Cited by 237Psychedelics and Drug StudiesPain Management and Placebo EffectStatistical Methods in Clinical Trials

The DOI matches its Crossref record; 174 of the 174 references it cites were found in a registry or an index.

Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials

Open access

Aday, Jacob S., Heifets, Boris D., Pratscher, Steven D., Bradley, Ellen, Rosen, Raymond, Woolley, Joshua D.·2022·Psychopharmacology

DOI 10.1007/s00213-022-06123-7PMC PMC10184717

Published version of a preprint

Open this paper in CoChat — free account

Abstract

RATIONALE: Psychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a wide range of conditions and disorders. However, expectancy effects and effective condition masking have been raised as critical limitations to the interpretability of the research. OBJECTIVE: In this article, we review the many methodological challenges of conducting psychedelic clinical trials and provide recommendations for improving the rigor of future research. RESULTS: Although some challenges are shared with psychotherapy and pharmacology trials more broadly, psychedelic clinical trials have to contend with several unique sources of potential bias. The subjective effects of a high-dose psychedelic are often so pronounced that it is difficult to mask participants to their treatment condition; the significant hype from positive media coverage on the clinical potential of psychedelics influences participants' expectations for treatment benefit; and participant unmasking and treatment expectations can interact in such a way that makes psychedelic therapy highly susceptible to large placebo and nocebo effects. Specific recommendations to increase the success of masking procedures and reduce the influence of participant expectancies are discussed in the context of study development, participant recruitment and selection, incomplete disclosure of the study design, choice of active placebo condition, as well as the measurement of participant expectations and masking efficacy. CONCLUSION: Incorporating the recommended design elements is intended to reduce the risk of bias in psychedelic clinical trials and thereby increases the ability to discern treatment-specific effects of psychedelic therapy.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Integrity signals

Registry

Crossref · 10.1007/s00213-022-06123-7

Cites

174 of 174 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

1 retracted

RETRACTED ARTICLE: MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials
Mithoefer, M. C., Feduccia, A. A., Jerome, L., Mithoefer, A., Wagner, M., Walsh, Z., Hamilton, S., Yazar-Klosinski, B., Emerson, A., & Doblin, R. (2019) · Psychopharmacology · doi:10.1007/s00213-019-05249-5 · Cited by 359
Retracted
The Cochrane Collaboration's tool for assessing risk of bias in randomised trials
Higgins, J. P. T., Altman, D. G., Gotzsche, P. C., Juni, P., Moher, D., Oxman, A. D., Savovic, J., Schulz, K. F., Weeks, L., Sterne, J. A. C., et al. (2011) · BMJ · doi:10.1136/bmj.d5928 · Cited by 33,817
The “Golden Age” of Probiotics: A Systematic Review and Meta-Analysis of Randomized and Observational Studies in Preterm Infants
Dermyshi, E., Wang, Y., Yan, C., Hong, W., Qiu, G., Gong, X., & Zhang, T. (2017) · Neonatology · doi:10.1159/000454668 · Cited by 24,586
Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations
Dworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Kerns, R. D., Ader, D. N., et al. (2008) · The Journal of Pain · doi:10.1016/j.jpain.2007.09.005 · Cited by 3,471
Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, & U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health (2006) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-4-79 · Cited by 2,856
Psychosomatic medicine in Germany: more timely than ever
Zipfel, S., Herzog, W., Kruse, J., & Henningsen, P. (2016) · Psychotherapy and Psychosomatics · doi:10.1159/000447701 · Cited by 2,323
Psychometric properties of the credibility/expectancy questionnaire
Devilly, G. J., & Borkovec, T. D. (2000) · Journal of Behavior Therapy and Experimental Psychiatry · doi:10.1016/s0005-7916(00)00012-4 · Cited by 2,295
A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee
Moseley, J. B., O’Malley, K. J., Petersen, N. J., Menke, T. J., Brody, B. A., Kuykendall, D. H., Hollingsworth, J. C., Ashton, C. M., & Wray, N. P. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa013259 · Cited by 2,262
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: a randomized double-blind trial
Griffiths, R. R., Johnson, M. W., Carducci, M. A., Umbricht, A., Richards, W. A., Richards, B. D., Cosimano, M. P., & Klinedinst, M. A. (2016) · Journal of Psychopharmacology · doi:10.1177/0269881116675513 · Cited by 2,201
Alliance in individual psychotherapy
Horvath, A. O., Del Re, A. C., Flückiger, C., & Symonds, D. (2011) · Psychotherapy · doi:10.1037/a0022186 · Cited by 2,072
What are biomarkers?
Strimbu, K., & Tavel, J. A. (2010) · Current Opinion in HIV and AIDS · doi:10.1097/coh.0b013e32833ed177 · Cited by 2,062
Regression to the mean: what it is and how to deal with it
Barnett, A. G. (2004) · International Journal of Epidemiology · doi:10.1093/ije/dyh299 · Cited by 1,988
The Hawthorne Effect: a randomised, controlled trial
McCarney, R., Warner, J. P., Iliffe, S., van Haselen, R. A., Griffin, M., & Fisher, P. (2007) · BMC Medical Research Methodology · doi:10.1186/1471-2288-7-30 · Cited by 1,838
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial.
Ross, S., Bossis, A., Guss, J., Agin-Liebes, G., Malone, T., Cohen, B., Mennenga, S. E., Belser, A., Kalliontzi, K., Babb, J., et al. (2016) · Journal of Psychopharmacology · doi:10.1177/0269881116675512 · Cited by 1,698
Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance
Griffiths, R. R., Richards, W. A., McCann, U., & Jesse, R. (2006) · Psychopharmacology · doi:10.1007/s00213-006-0457-5 · Cited by 1,684 · cited 5×
“We have reviewed studies where incomplete disclosure has been used to reduce participants’ certainty regarding their treatment assignment (Bershad et al. 2019; Carbonaro et al. 2018; Griffiths et al. 2006; Reissig et al. 2012).”
Influential
Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial
Davis, A. K., Barrett, F. S., May, D. G., Cosimano, M. P., Sepeda, N. D., Johnson, M. W., Finan, P. H., & Griffiths, R. R. (2021) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2020.3285 · Cited by 1,301
Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer
Grob, C. S., Danforth, A. L., Chopra, G. S., Hagerty, M., McKay, C. R., Halberstadt, A. L., & Greer, G. R. (2011) · Archives of General Psychiatry · doi:10.1001/archgenpsychiatry.2010.116 · Cited by 1,206
Pilot study of the 5-HT 2A R agonist psilocybin in the treatment of tobacco addiction
Johnson, M. W., Garcia-Romeu, A., Cosimano, M. P., & Griffiths, R. R. (2014) · Journal of Psychopharmacology · doi:10.1177/0269881114548296 · Cited by 914
Mystical-type experiences occasioned by psilocybin mediate the attribution of personal meaning and spiritual significance 14 months later
Griffiths, R., Richards, W., Johnson, M., McCann, U., & Jesse, R. (2008) · Journal of Psychopharmacology · doi:10.1177/0269881108094300 · Cited by 905
The Importance of Placebo Effects in Pain Treatment and Research
Turner, J. A. (1994) · JAMA · doi:10.1001/jama.1994.03510440069036 · Cited by 871
Adaptive designs in clinical trials: why use them, and how to run and report them
Pallmann, P., Bedding, A. W., Choodari-Oskooei, B., Dimairo, M., Flight, L., Hampson, L. V., Holmes, J., Mander, A. P., Odondi, L., Sydes, M. R., et al. (2018) · BMC Medicine · doi:10.1186/s12916-018-1017-7 · Cited by 829
Understanding the Hawthorne effect
Sedgwick, P., & Greenwood, N. (2015) · BMJ · doi:10.1136/bmj.h4672 · Cited by 824
Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension
Calvert, M., Kyte, D., Mercieca-Bebber, R., Slade, A., Chan, A.-W., King, M. T., and the SPIRIT-PRO Group, Hunn, A., Bottomley, A., Regnault, A., et al. (2018) · JAMA · doi:10.1001/jama.2017.21903 · Cited by 814
The Effect of Treatment Expectation on Drug Efficacy: Imaging the Analgesic Benefit of the Opioid Remifentanil
Bingel, U., Wanigasekera, V., Wiech, K., Ni Mhuircheartaigh, R., Lee, M. C., Ploner, M., & Tracey, I. (2011) · Science Translational Medicine · doi:10.1126/scitranslmed.3001244 · Cited by 810
Placebo interventions for all clinical conditions
Hróbjartsson, A., & Gøtzsche, P. C. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003974.pub3 · Cited by 777
The placebo response in medicine: minimize, maximize or personalize?
Enck, P., Bingel, U., Schedlowski, M., & Rief, W. (2013) · Nature Reviews Drug Discovery · doi:10.1038/nrd3923 · Cited by 671
The importance of patient-reported outcomes in clinical trials and strategies for future optimization
Mercieca-Bebber, R., King, M. T., Calvert, M. J., Stockler, M. R., & Friedlander, M. (2018) · Patient Related Outcome Measures · doi:10.2147/prom.s156279 · Cited by 659
Therapist adherence/competence and treatment outcome: A meta-analytic review.
Webb, C. A., DeRubeis, R. J., & Barber, J. P. (2010) · Journal of Consulting and Clinical Psychology · doi:10.1037/a0018912 · Cited by 657
Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations
Dworkin, R. H., Turk, D. C., McDermott, M. P., Peirce-Sandner, S., Burke, L. B., Cowan, P., Farrar, J. T., Hertz, S., Raja, S. N., Rappaport, B. A., et al. (2009) · Pain · doi:10.1016/j.pain.2009.08.019 · Cited by 654
Untitled work
(2020) · doi:10.1056/nejmra1907805 · Cited by 634
Overview: hypochondriasis, bodily complaints, and somatic styles
BARSKY, A. J., & Klerman, G. L. (1983) · American Journal of Psychiatry · doi:10.1176/ajp.140.3.273 · Cited by 605
Biomarkers and surrogate endpoints in clinical trials
Fleming, T. R., & Powers, J. H. (2012) · Statistics in Medicine · doi:10.1002/sim.5403 · Cited by 559
The subjective effects of psychedelics are necessary for their enduring therapeutic effects
Yaden, D. B., & Griffiths, R. R. (2021) · ACS Pharmacology & Translational Science · doi:10.1021/acsptsci.0c00194 · Cited by 541
Waiting list may be a nocebo condition in psychotherapy trials: a contribution from network meta-analysis
Furukawa, T. A., Noma, H., Caldwell, D. M., Honyashiki, M., Shinohara, K., Imai, H., Chen, P., Hunot, V., & Churchill, R. (2014) · Acta Psychiatrica Scandinavica · doi:10.1111/acps.12275 · Cited by 521
Attenuation of Antidepressant Effects of Ketamine by Opioid Receptor Antagonism
Williams, N. R., Heifets, B. D., Blasey, C., Sudheimer, K., Pannu, J., Pankow, H., Hawkins, J., Birnbaum, J., Lyons, D. M., Rodriguez, C. I., et al. (2018) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2018.18020138 · Cited by 519
Self-citation
Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors
Hróbjartsson, A., Thomsen, A. S. S., Emanuelsson, F., Tendal, B., Hilden, J., Boutron, I., Ravaud, P., & Brorson, S. (2012) · BMJ · doi:10.1136/bmj.e1119 · Cited by 505
Set and setting, psychedelics and the placebo response: an extra-pharmacological perspective on psychopharmacology
Hartogsohn, I. (2016) · Journal of Psychopharmacology · doi:10.1177/0269881116677852 · Cited by 483
A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD)
Oehen, P., Traber, R., Widmer, V., & Schnyder, U. (2012) · Journal of Psychopharmacology · doi:10.1177/0269881112464827 · Cited by 424
Predicting responses to psychedelics: a prospective study
Haijen, E. C. H. M., Kaelen, M., Roseman, L., Timmermann, C., Kettner, H., Russ, S., Nutt, D., Daws, R. E., Hampshire, A. D. G., Lorenz, R., et al. (2018) · Frontiers in Pharmacology · doi:10.3389/fphar.2018.00897 · Cited by 417
Proceeding From Observed Correlation to Causal Inference: The Use of Natural Experiments
Rutter, M. L. (2007) · Perspectives on Psychological Science · doi:10.1111/j.1745-6916.2007.00050.x · Cited by 409
Factor Analysis of the Mystical Experience Questionnaire: A Study of Experiences Occasioned by the Hallucinogen Psilocybin
MacLean, K. A., Leoutsakos, J. S., Johnson, M. W., & Griffiths, R. R. (2012) · Journal for the Scientific Study of Religion · doi:10.1111/j.1468-5906.2012.01685.x · Cited by 405
Statistics Notes: Some examples of regression towards the mean
Bland, J. M., & Altman, D. G. (1994) · BMJ · doi:10.1136/bmj.309.6957.780 · Cited by 381
Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations
Dworkin, R. H., Turk, D. C., Peirce-Sandner, S., Baron, R., Bellamy, N., Burke, L. B., Chappell, A., Chartier, K., Cleeland, C. S., Costello, A., et al. (2010) · Pain · doi:10.1016/j.pain.2010.02.018 · Cited by 381
Expectations
Constantino, M. J., Arnkoff, D. B., Glass, C. R., Ametrano, R. M., & Smith, J. Z. (2011) · Journal of Clinical Psychology · doi:10.1002/jclp.20754 · Cited by 367
The subjective effects of psychedelics may not be necessary for their enduring therapeutic effects
Olson, D. E. (2021) · ACS Pharmacology & Translational Science · doi:10.1021/acsptsci.0c00192 · Cited by 329
Potential Therapeutic Effects of Psilocybin
Johnson, M. W., & Griffiths, R. R. (2017) · Neurotherapeutics · doi:10.1007/s13311-017-0542-y · Cited by 328
Blinding and expectancy confounds in psychedelic randomized controlled trials
Muthukumaraswamy, S. D., Forsyth, A., & Lumley, T. (2021) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2021.1933434 · Cited by 324
Exploratory randomized controlled trial evaluating the impact of a waiting list control design
Cunningham, J. A., Kypri, K., & McCambridge, J. (2013) · BMC Medical Research Methodology · doi:10.1186/1471-2288-13-150 · Cited by 321
LSD enhances suggestibility in healthy volunteers
Carhart-Harris, R. L., Kaelen, M., Whalley, M. G., Bolstridge, M., Feilding, A., & Nutt, D. J. (2015) · Psychopharmacology · doi:10.1007/s00213-014-3714-z · Cited by 320
The balanced placebo design: Methodological considerations
Rohsenow, D. J., & Marlatt, G. A. (1981) · Addictive Behaviors · doi:10.1016/0306-4603(81)90003-4 · Cited by 310
Long-term effects of psychedelic drugs: A systematic review
Aday, J. S., Mitzkovitz, C. M., Bloesch, E. K., Davoli, C. C., & Davis, A. K. (2020) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2020.03.017 · Cited by 279
Self-citation
Peak experiences and the afterglow phenomenon: When and how do therapeutic effects of hallucinogens depend on psychedelic experiences?
Majić, T., Schmidt, T. T., & Gallinat, J. (2015) · Journal of Psychopharmacology · doi:10.1177/0269881114568040 · Cited by 278
A Model of Placebo Response in Antidepressant Clinical Trials
Rutherford, B. R., & Roose, S. P. (2013) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2012.12040474 · Cited by 268
Patients' expectations regarding medical treatment: a critical review of concepts and their assessment
Laferton, J. A. C., Kube, T., Salzmann, S., Auer, C. J., & Shedden-Mora, M. C. (2017) · Frontiers in Psychology · doi:10.3389/fpsyg.2017.00233 · Cited by 267
A meta-analysis of the association between patients’ early treatment outcome expectation and their posttreatment outcomes.
Constantino, M. J., Vîslă, A., Coyne, A. E., & Boswell, J. F. (2018) · Psychotherapy · doi:10.1037/pst0000169 · Cited by 260
Psychotherapy and the placebo effect.
ROSENTHAL, D. M., & Frank, J. D. (1956) · Psychological Bulletin · doi:10.1037/h0044068 · Cited by 256
Is Ecstasy an “Empathogen”? Effects of +/- 3,4-Methylenedioxymethamphetamine on Prosocial Feelings and Identification of Emotional States in Others
Bedi, G., Hyman, D., & de Wit, H. (2010) · Biological Psychiatry · doi:10.1016/j.biopsych.2010.08.003 · Cited by 247
REACTIONS TO PSILOCYBJN ADMINISTERED IN A SUPPORTIVE ENVIRONMENT
Leary, T., Litwin, G. H., & Metzner, R. (1963) · The Journal of Nervous and Mental Disease · doi:10.1097/00005053-196312000-00007 · Cited by 245
Psychedelics alter metaphysical beliefs
Timmermann, C., Kettner, H., Letheby, C., Roseman, L., Rosas, F. E., & Carhart-Harris, R. L. (2021) · Scientific Reports · doi:10.1038/s41598-021-01209-2 · Cited by 243
Reconsidering the Value of Covert Research
Roulet, T. J., Gill, M., Stenger, S., & Gill, D. J. (2017) · Organizational Research Methods · doi:10.1177/1094428117698745 · Cited by 242
Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework
Gold, S. M., Enck, P., Hasselmann, H., Friede, T., Hegerl, U., Mohr, D. C., & Otte, C. (2017) · The Lancet Psychiatry · doi:10.1016/s2215-0366(17)30153-0 · Cited by 236
The meaning-enhancing properties of psychedelics and their mediator role in psychedelic therapy, spirituality, and creativity
Hartogsohn, I. (2018) · Frontiers in Neuroscience · doi:10.3389/fnins.2018.00129 · Cited by 229
Microdosing psychedelics: More questions than answers? An overview and suggestions for future research
Kuypers, K. P. C., Ng, L., Erritzøe, D., Knudsen, G. M., Nichols, C. D., Nichols, D. E., Pani, L., Soula, A., & Nutt, D. (2019) · Journal of Psychopharmacology · doi:10.1177/0269881119857204 · Cited by 227
How to Change Your Mind: What the New Science of Psychedelics Teaches Us about Consciousness, Dying, Addiction, Depression, and Transcendence,
Rhead, J. (2018) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2018.1535149 · Cited by 224
Placebos in chronic pain: evidence, theory, ethics, and use in clinical practice
Kaptchuk, T. J., Hemond, C. C., & Miller, F. G. (2020) · BMJ · doi:10.1136/bmj.m1668 · Cited by 224
Predicting Reactions to Psychedelic Drugs: A Systematic Review of States and Traits Related to Acute Drug Effects
Aday, J. S., Davis, A. K., Mitzkovitz, C. M., Bloesch, E. K., & Davoli, C. C. (2021) · ACS Pharmacology & Translational Science · doi:10.1021/acsptsci.1c00014 · Cited by 224
Self-citation
Development of the Stanford Expectations of Treatment Scale (SETS): A tool for measuring patient outcome expectancy in clinical trials
Younger, J., Gandhi, V., Hubbard, E., & Mackey, S. (2012) · Clinical Trials · doi:10.1177/1740774512465064 · Cited by 212 · cited 2×
“2021) recommend the use of established measures of expectancy, such as the Stanford Expectations of Treatment Scale (Younger et al. 2012), which is a valid and reliable measure of participants’ positive and negative treatment expectancies.”
A Brief Intervention Reduces Hazardous and Harmful Drinking in Emergency Department Patients
D'Onofrio, G., Fiellin, D. A., Pantalon, M. V., Chawarski, M. C., Owens, P. H., Degutis, L. C., Busch, S. H., Bernstein, S. L., & O'Connor, P. G. (2012) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2012.02.006 · Cited by 207
Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations
Smith, S. M., Dworkin, R. H., Turk, D. C., McDermott, M. P., Eccleston, C., Farrar, J. T., Rowbotham, M. C., Bhagwagar, Z., Burke, L. B., Cowan, P., et al. (2020) · Pain · doi:10.1097/j.pain.0000000000001952 · Cited by 194
Self-blinding citizen science to explore psychedelic microdosing
Szigeti, B., Kartner, L., Blemings, A., Rosas, F., Feilding, A., Nutt, D. J., Carhart-Harris, R. L., & Erritzoe, D. (2021) · eLife · doi:10.7554/elife.62878 · Cited by 192
The nocebo effect of drugs
Planès, S., Villier, C., & Mallaret, M. (2016) · Pharmacology Research & Perspectives · doi:10.1002/prp2.208 · Cited by 186
Regression to the mean in treated versus untreated chronic pain
Whitney, C. W., & Korff, M. V. (1992) · Pain · doi:10.1016/0304-3959(92)90032-7 · Cited by 178
A randomised controlled trial of vaporised Δ9-tetrahydrocannabinol and cannabidiol alone and in combination in frequent and infrequent cannabis users: acute intoxication effects
Solowij, N., Broyd, S. J., Greenwood, L., van Hell, H., Martelozzo, D., Rueb, K., Todd, J., Liu, Z., Galettis, P., Martin, J. H., et al. (2019) · European Archives of Psychiatry and Clinical Neuroscience · doi:10.1007/s00406-019-00978-2 · Cited by 176
Attenuation of antidepressant and antisuicidal effects of ketamine by opioid receptor antagonism
Williams, N. R., Heifets, B. D., Bentzley, B. S., Blasey, C., Sudheimer, K. D., Hawkins, J., Lyons, D. M., & Schatzberg, A. F. (2019) · Molecular Psychiatry · doi:10.1038/s41380-019-0503-4 · Cited by 174
Self-citation
MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
Wolfson, P. E., Andries, J., Feduccia, A. A., Jerome, L., Wang, J. B., Williams, E., Carlin, S. C., Sola, E., Hamilton, S., Yazar-Klosinski, B., et al. (2020) · Scientific Reports · doi:10.1038/s41598-020-75706-1 · Cited by 169
Deception in Research on the Placebo Effect
Miller, F. G., Wendler, D. S., & Swartzman, L. C. (2005) · PLoS Medicine · doi:10.1371/journal.pmed.0020262 · Cited by 168
Methods of Blinding in Reports of Randomized Controlled Trials Assessing Pharmacologic Treatments: A Systematic Review
Boutron, I., Estellat, C., Guittet, L., Dechartres, A., Sackett, D. L., Hróbjartsson, A., & Ravaud, P. (2006) · PLoS Medicine · doi:10.1371/journal.pmed.0030425 · Cited by 168
Patient reported outcomes: looking beyond the label claim
Doward, L. C., Gnanasakthy, A., & Baker, M. G. (2010) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-8-89 · Cited by 162
Psychedelics, placebo effects, and set and setting: Insights from common factors theory of psychotherapy
Gukasyan, N., & Nayak, S. M. (2021) · Transcultural Psychiatry · doi:10.1177/1363461520983684 · Cited by 159
Association Between Placebo-Activated Neural Systems and Antidepressant Responses
Peciña, M., Bohnert, A. M., Sikora, M., Avery, E. T., Langenecker, S. A., Mickey, B. J., & Zubieta, J. (2015) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2015.1335 · Cited by 158
Association of Combined Naltrexone and Ketamine With Depressive Symptoms in a Case series of Patients With Depression and Alcohol Use Disorder
Yoon, G., Petrakis, I. L., & Krystal, J. H. (2019) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2018.3990 · Cited by 155
Tripping on nothing: placebo psychedelics and contextual factors
Olson, J. A., Suissa-Rocheleau, L., Lifshitz, M., Raz, A., & Veissière, S. P. L. (2020) · Psychopharmacology · doi:10.1007/s00213-020-05464-5 · Cited by 155
Pain, placebo, and test of treatment efficacy: a narrative review
Vase, L., & Wartolowska, K. A. (2019) · British Journal of Anaesthesia · doi:10.1016/j.bja.2019.01.040 · Cited by 151
Commentary: Measuring the success of blinding in RCTs: don't, must, can't or needn't?
Sackett, D. L. (2007) · International Journal of Epidemiology · doi:10.1093/ije/dym088 · Cited by 150
The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations
Smith, S. M., Dworkin, R. H., Turk, D. C., Baron, R., Polydefkis, M. J., Tracey, I., Borsook, D., Edwards, R. R., Harris, R. E., Wager, T. D., et al. (2017) · Journal of Pain · doi:10.1016/j.jpain.2017.02.429 · Cited by 150
Ethics and ego dissolution: the case of psilocybin
Smith, W. R., & Sisti, D. (2021) · Journal of Medical Ethics · doi:10.1136/medethics-2020-106070 · Cited by 146
Positive expectations predict improved mental-health outcomes linked to psychedelic microdosing
Kaertner, L. S., Steinborn, M. B., Kettner, H., Spriggs, M. J., Roseman, L., Buchborn, T., Balaet, M., Timmermann, C., Erritzoe, D., & Carhart-Harris, R. L. (2021) · Scientific Reports · doi:10.1038/s41598-021-81446-7 · Cited by 145
The Psychedelic Explorer's Guide: Safe, Therapeutic, and Sacred Journeys
Fadiman, J. (2011) · Cited by 138
Towards a proposal for assessment of blinding success in clinical trials: up-to-date review
Kolahi, J., Bang, H., & Park, J. (2009) · Community Dentistry and Oral Epidemiology · doi:10.1111/j.1600-0528.2009.00494.x · Cited by 137
Ayahuasca’s ‘afterglow’: improved mindfulness and cognitive flexibility in ayahuasca drinkers
Murphy-Beiner, A., & Soar, K. (2020) · Psychopharmacology · doi:10.1007/s00213-019-05445-3 · Cited by 135
Set, setting, and matrix
Eisner, B. (1997) · Journal of Psychoactive Drugs · doi:10.1080/02791072.1997.10400190 · Cited by 135
Blinding in randomised clinical trials of psychological interventions: a retrospective study of published trial reports
Juul, S., Gluud, C., Simonsen, S., Frandsen, F. W., Kirsch, I., & Jakobsen, J. C. (2021) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2020-111407 · Cited by 135
Double-blind comparison of the two hallucinogens psilocybin and dextromethorphan: similarities and differences in subjective experiences
Carbonaro, T. M., Johnson, M. W., Hurwitz, E., & Griffiths, R. R. (2018) · Psychopharmacology · doi:10.1007/s00213-017-4769-4 · Cited by 133
How Sound Is the Double-Blind Design for Evaluating Psychotropic Drugs?
Fisher, S., & Greenberg, R. P. (1993) · The Journal of Nervous and Mental Disease · doi:10.1097/00005053-199306000-00002 · Cited by 126
Magnitude of the Placebo Response Across Treatment Modalities Used for Treatment-Resistant Depression in Adults: A Systematic Review and Meta-analysis
Jones, B. D. M., Razza, L. B., Weissman, C. R., Karbi, J., Vine, T., Mulsant, L. S., Brunoni, A. R., Husain, M. I., Mulsant, B. H., Blumberger, D. M., et al. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.25531 · Cited by 121
Placebo effects in psychotherapy: a framework
Enck, P., & Zipfel, S. (2019) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2019.00456 · Cited by 115
Why Do Clinical Trials Fail?
Kobak, K. A., Kane, J., Thase, M. E., & Nierenberg, A. A. (2007) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0b013e31802eb4b7 · Cited by 112
A placebo-controlled study of the effects of ayahuasca, set and setting on mental health of participants in ayahuasca group retreats
Uthaug, M. V., Mason, N. L., Toennes, S. W., Reckweg, J. T., de Sousa Fernandes Perna, E. B., Kuypers, K. P. C., van Oorsouw, K., Riba, J., & Ramaekers, J. G. (2021) · Psychopharmacology · doi:10.1007/s00213-021-05817-8 · Cited by 112
Trends in LSD use among US adults: 2015–2018
Yockey, R. A., Vidourek, R. A., & King, K. A. (2020) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2020.108071 · Cited by 111
How blind is blind? Assessment of patient and doctor medication guesses in a placebo-controlled trial of imipramine and phenelzine
Rabkin, J. G., Markowitz, J. S., Stewart, J. W., McGrath, P. J., Harrison, W. M., Quitkin, F. M., & Klein, D. F. (1986) · Psychiatry Research · doi:10.1016/0165-1781(86)90094-6 · Cited by 103
Molecular mechanisms of placebo responses in humans
Peciña, M., & Zubieta, J.-K. (2014) · Molecular Psychiatry · doi:10.1038/mp.2014.164 · Cited by 103
Treatment Expectations and Preferences as Predictors of Outcome of Acupuncture for Chronic Back Pain
Sherman, K. J., Cherkin, D. C., Ichikawa, L., Avins, A. L., Delaney, K. M., Barlow, W. E., Khalsa, P. S., & Deyo, R. A. (2010) · Spine · doi:10.1097/brs.0b013e3181c2a8d3 · Cited by 100
A Controlled Study of Lysergide in the Treatment of Alcoholism. I . The Effects on Drinking Behavior
Smart, R. G., Storm, T., Baker, E. F. W., & Solursh, L. P. (1966) · Quarterly Journal of Studies on Alcohol · doi:10.15288/qjsa.1966.27.469 · Cited by 100
Registered clinical studies investigating psychedelic drugs for psychiatric disorders
Siegel, A. N., Meshkat, S., Benitah, K., Lipsitz, O., Gill, H., Lui, L. M. W., Teopiz, K. M., McIntyre, R. S., & Rosenblat, J. D. (2021) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2021.05.019 · Cited by 97
Acute effects of ayahuasca on neuropsychological performance: differences in executive function between experienced and occasional users
Bouso, J. C., Fábregas, J. M., Antonijoan, R. M., Rodríguez-Fornells, A., & Riba, J. (2013) · Psychopharmacology · doi:10.1007/s00213-013-3167-9 · Cited by 96
The use of waitlists as control conditions in anxiety disorders research
Patterson, B., Boyle, M. H., Kivlenieks, M., & Van Ameringen, M. (2016) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2016.08.015 · Cited by 94
Systematized Review of Psychotherapeutic Components of Psilocybin-Assisted Psychotherapy
Horton, D. M., Morrison, B., & Schmidt, J. A. (2021) · American Journal of Psychotherapy · doi:10.1176/appi.psychotherapy.20200055 · Cited by 93
High doses of dextromethorphan, an NMDA antagonist, produce effects similar to classic hallucinogens
Reissig, C. J., Carter, L. P., Johnson, M. W., Mintzer, M. Z., Klinedinst, M. A., & Griffiths, R. R. (2012) · Psychopharmacology · doi:10.1007/s00213-012-2680-6 · Cited by 91
Examining changes in personality following shamanic ceremonial use of ayahuasca
Weiss, B., Miller, J. D., Carter, N. T., & Keith Campbell, W. (2021) · Scientific Reports · doi:10.1038/s41598-021-84746-0 · Cited by 86
A qualitative study of changes in expectations over time among patients with chronic low back pain seeking four CAM therapies
Eaves, E. R., Sherman, K. J., Ritenbaugh, C., Hsu, C. W., Nichter, M., Turner, J. A., & Cherkin, D. C. (2015) · BMC Complementary and Alternative Medicine · doi:10.1186/s12906-015-0531-9 · Cited by 81
The next generation of mindfulness-based intervention research: what have we learned and where are we headed?
Rosenkranz, M. A., Dunne, J. D., & Davidson, R. J. (2019) · Current Opinion in Psychology · doi:10.1016/j.copsyc.2018.12.022 · Cited by 81
Diversity, equity, and access in psychedelic medicine
Williams, M. T., & Labate, B. C. (2019) · Journal of Psychedelic Studies · doi:10.1556/2054.2019.032 · Cited by 79
Right-Wing Psychedelia: Case Studies in Cultural Plasticity and Political Pluripotency
Pace, B. A., & Devenot, N. (2021) · Frontiers in Psychology · doi:10.3389/fpsyg.2021.733185 · Cited by 79
Effects of MDMA on attention to positive social cues and pleasantness of affective touch
Bershad, A. K., Mayo, L. M., Hedger, K. V., McGlone, F. P., Walker, S. C., & de Wit, H. (2019) · Neuropsychopharmacology · doi:10.1038/s41386-019-0402-z · Cited by 76
The relation between outcome expectation, therapeutic alliance, and outcome among depressed patients in group cognitive-behavioral therapy
Vîslă, A., Constantino, M. J., Newkirk, K., Ogrodniczuk, J. S., & Söchting, I. (2016) · Psychotherapy Research · doi:10.1080/10503307.2016.1218089 · Cited by 75
An examination of the efficiency of the sequential parallel design in psychiatric clinical trials
Tamura, R., & Huang, X. (2007) · Clinical Trials · doi:10.1177/1740774507081217 · Cited by 73
Guidance for Industry and FDA Staff
(2011) · Elsevier eBooks · doi:10.1016/b978-1-4377-4461-3.10017-3 · Cited by 68
Assessing the effects of methodological differences on outcomes in the use of psychedelics in the treatment of anxiety and depressive disorders: A systematic review and meta-analysis
Leger, R. F., & Unterwald, E. M. (2021) · Journal of Psychopharmacology · doi:10.1177/02698811211044688 · Cited by 61
Focus Article Report of the NIH Task Force on Research Standards for Chronic Low Back Pain
Deyo, R. A., Dworkin, S. F., Amtmann, D., Andersson, G. B. J., BORENSTEIN, D. G., Carragee, E. J., Carrino, J. A., Chou, R., Cook, K. F., Delitto, A., et al. (2014) · Clinical Journal of Pain · doi:10.1097/ajp.0000000000000120 · Cited by 60
2019: A year of expansion in psychedelic research, industry, and deregulation
Aday, J. S., Bloesch, E. K., & Davoli, C. C. (2020) · Drug Science Policy and Law · doi:10.1177/2050324520974484 · Cited by 60
Self-citation
A social affective neuroscience lens on placebo analgesia
Atlas, L. Y. (2021) · Trends in Cognitive Sciences · doi:10.1016/j.tics.2021.07.016 · Cited by 60
Psychedelic therapy: a roadmap for wider acceptance and utilization
Marks, M., & Cohen, I. G. (2021) · Nature Medicine · doi:10.1038/s41591-021-01530-3 · Cited by 59
Are placebo and drug-specific effects additive? Questioning basic assumptions of double-blinded randomized clinical trials and presenting novel study designs
Κube, T., & Rief, W. (2016) · Drug Discovery Today · doi:10.1016/j.drudis.2016.11.022 · Cited by 59
Double-blindness Procedures, Rater Blindness, and Ratings of Outcome
Başoğlu, M. (1997) · Archives of General Psychiatry · doi:10.1001/archpsyc.1997.01830200078011 · Cited by 58
Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial
Burns, J. W., Jensen, M. P., Thorn, B., Lillis, T. A., Carmody, J., Newman, A. K., & Keefe, F. (2022) · Pain · doi:10.1097/j.pain.0000000000002357 · Cited by 58
A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers
Reckweg, J., Mason, N. L., van Leeuwen, C., Toennes, S. W., Terwey, T. H., & Ramaekers, J. G. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.760671 · Cited by 58
Do natural experiments have an important future in the study of mental disorders?
Thapar, A., & Rutter, M. L. (2019) · Psychological Medicine · doi:10.1017/s0033291718003896 · Cited by 57
Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations
Gewandter, J. S., Dworkin, R. H., Turk, D. C., Devine, E. G., Hewitt, D., Jensen, M. P., Katz, N. P., Kirkwood, A. A., Malamut, R. I., Markman, J. D., et al. (2019) · Journal of Pain · doi:10.1016/j.jpain.2019.12.003 · Cited by 56
Comparison of psychological placebo and waiting list control conditions in the assessment of cognitive behavioral therapy for the treatment of generalized anxiety disorder: a meta-analysis.
Zhu, Z., Zhang, L., Jiang, J., Li, W., Cao, X., Zhou, Z., Zhang, T., & Li, C. (2014) · Europe PMC (PubMed Central) · doi:10.11919/j.issn.1002-0829.214173 · Cited by 54
Isness: Using Multi-Person VR to Design Peak Mystical Type Experiences Comparable to Psychedelics
Glowacki, D. R., Wonnacott, M. D., Freire, R., Glowacki, B. R., Gale, E. M., Pike, J. E., de Haan, T., Chatziapostolou, M., & Metatla, O. (2020) · Proceedings of the 2020 CHI Conference on Human Factors in Computing Systems · doi:10.1145/3313831.3376649 · Cited by 54
Caution at psychiatry’s psychedelic frontier
Burke, M. J., & Blumberger, D. M. (2021) · Nature Medicine · doi:10.1038/s41591-021-01524-1 · Cited by 54
Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?
Carhart-Harris, R. L., Wagner, A. C., Agrawal, M., Kettner, H., Rosenbaum, J. F., Gazzaley, A., Nutt, D. J., & Erritzoe, D. (2022) · Journal of Psychopharmacology · doi:10.1177/02698811211008567 · Cited by 51
Perceived treatment, feedback, and placebo effects in double-blind RCTs: an experimental analysis
Colagiuri, B., & Boakes, R. A. (2009) · Psychopharmacology · doi:10.1007/s00213-009-1743-9 · Cited by 50
Effects of psilocybin microdosing on awe and aesthetic experiences: a preregistered field and lab-based study
van Elk, M., Fejer, G., Lempe, P., Prochazkova, L., Kuchař, M., Hájková, K., & Marschall, J. (2021) · Psychopharmacology · doi:10.1007/s00213-021-05857-0 · Cited by 50
Concurrent Use of Buprenorphine, Methadone, or Naltrexone Does Not Inhibit Ketamine’s Antidepressant Activity
Marton, T., Barnes, D. E., Wallace, A., & Woolley, J. D. (2019) · Biological Psychiatry · doi:10.1016/j.biopsych.2019.02.008 · Cited by 49
Self-citation
Is there a genuine placebo effect in acute depression treatments? A reassessment of regression to the mean and spontaneous remission
Hengartner, M. P. (2019) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2019-111161 · Cited by 48
A Literature Review of Therapeutic Expectancy Effects
Tambling, R. B. (2012) · Contemporary Family Therapy · doi:10.1007/s10591-012-9201-y · Cited by 47
Efficacy of selective serotonin reuptake inhibitors in the absence of side effects: a mega-analysis of citalopram and paroxetine in adult depression
Hieronymus, F., Lisinski, A., Nilsson, S., & Eriksson, E. (2017) · Molecular Psychiatry · doi:10.1038/mp.2017.147 · Cited by 44
Enhancing the acute psychological benefits of green exercise: an investigation of expectancy effects
Flowers, E. P., Freeman, P., & Gladwell, V. F. (2018) · Psychology of Sport and Exercise · doi:10.1016/j.psychsport.2018.08.014 · Cited by 44
What can be done to control the placebo response in clinical trials? A narrative review
Evans, K., Colloca, L., Peciña, M., & Katz, N. P. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106503 · Cited by 44
A systematic review and meta-analysis of the success of blinding in antidepressant RCTs
Scott, A. J., Sharpe, L., & Colagiuri, B. (2021) · Psychiatry Research · doi:10.1016/j.psychres.2021.114297 · Cited by 42
Who is blind in psychedelic research? Letter to the editor regarding: blinding and expectancy confounds in psychedelic randomized controlled trials
Schenberg, E. E. (2021) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2021.1951473 · Cited by 41
Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?
Holbein, M. E. B., Berglund, J. P., Weatherwax, K. J., Gerber, D. E., & Adamo, J. E. (2015) · Clinical and Translational Science · doi:10.1111/cts.12255 · Cited by 36
Cannabis-induced oceanic boundlessness
Earleywine, M., Ueno, L. F., Mian, M. N., & Altman, B. R. (2021) · Journal of Psychopharmacology · doi:10.1177/0269881121997099 · Cited by 36
A Comparison of Deceptive and Non-Deceptive Placebo Analgesia: Efficacy and Ethical Consequences
Mundt, J. M., Roditi, D., & Robinson, M. E. (2016) · Annals of Behavioral Medicine · doi:10.1007/s12160-016-9854-0 · Cited by 34
American Trip: Set, Setting, and the Psychedelic Experience in the Twentieth Century
Hartogsohn, I. (2020) · Cited by 34
Association of Single-blind Placebo Run-in Periods With the Placebo Response in Randomized Clinical Trials of Antidepressants
Scott, A. J., Sharpe, L., Quinn, V. F., & Colagiuri, B. (2021) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2021.3204 · Cited by 34
Psychedelics alter metaphysical beliefsPreprint
Timmermann, C., Kettner, H., Letheby, C., Roseman, L., Rosas, F. E., & Carhart-Harris, R. L. (2021) · PsyArXiv (OSF Preprints) · doi:10.31234/osf.io/f6sjk · Cited by 34
Why Psychiatry Needs Psychedelics and Psychedelics Need Psychiatry
Sessa, B. (2014) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2014.877322 · Cited by 33
Placebo effects in psychotherapy: A flawed concept and a contorted history.
Wampold, B. E., Frost, N. D., & Yulish, N. E. (2016) · Psychology of Consciousness Theory Research and Practice · doi:10.1037/cns0000045 · Cited by 32
Designing and conducting proof-of-concept chronic pain analgesic clinical trials
Campbell, C. M., Gilron, I., Doshi, T. L., & Raja, S. N. (2018) · PAIN Reports · doi:10.1097/pr9.0000000000000697 · Cited by 32
Purpose-guided trial design in health-related behavioral intervention research.
Freedland, K. E. (2020) · Health Psychology · doi:10.1037/hea0000867 · Cited by 32
The Psychedelic Explorer’s Guide: Safe, Therapeutic, and Sacred Journeys
Rhead, J. (2014) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2014.948329 · Cited by 30
Design and conduct of confirmatory chronic pain clinical trials
Katz, N. P. (2020) · PAIN Reports · doi:10.1097/pr9.0000000000000854 · Cited by 30
A theoretical analysis showed that blinding cannot eliminate potential for bias associated with beliefs about allocation in randomized clinical trials
Mathieu, E., Herbert, R., McGeechan, K., Herbert, J. J., & Barratt, A. L. (2014) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2014.02.001 · Cited by 29
Effect of a Symptom Diary on Symptom Frequency and Intensity in Healthy Subjects
Ferrari, R. R., & RUSSELL, A. S. (2010) · The Journal of Rheumatology · doi:10.3899/jrheum.100513 · Cited by 28
Maintenance of Blinding in Clinical Trials and the Implications for Studying Analgesia Using Cannabinoids
Wilsey, B. L., Deutsch, R., & Marcotte, T. D. (2016) · Cannabis and Cannabinoid Research · doi:10.1089/can.2016.0016 · Cited by 28
Hypnotic suggestion produces mystical-type experiences in the laboratory: A demonstration proof.
Lynn, S. J., & Evans, J. V. (2017) · Psychology of Consciousness Theory Research and Practice · doi:10.1037/cns0000105 · Cited by 28
What Is Controlled for in Placebo-Controlled Trials?
Fillingim, R. B., & Price, D. D. (2005) · Mayo Clinic Proceedings · doi:10.4065/80.9.1119 · Cited by 24
The impact of ecological momentary assessment on posttraumatic stress symptom trajectory
Dewey, D., McDonald, M. K., Brown, W. J., Boyd, S. J., Bunnell, B. E., & Schuldberg, D. (2015) · Psychiatry Research · doi:10.1016/j.psychres.2015.09.009 · Cited by 23
Antecedents of mystical experience and dread in intensive meditation.
Russ, S. L., & Elliott, M. S. (2017) · Psychology of Consciousness Theory Research and Practice · doi:10.1037/cns0000119 · Cited by 23
Ten Practical Recommendations for Improving Blinding Integrity and Reporting in Psychotherapy Trials
Mataix-Cols, D., & Andersson, E. (2021) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2021.1419 · Cited by 23
Impact of Daily Assessments on Distress and PTSD Symptoms in Trauma-Exposed Women
Pedersen, E. R., Kaysen, D. L., Lindgren, K. P., Blayney, J. A., & Simpson, T. L. (2013) · Journal of Interpersonal Violence · doi:10.1177/0886260513505705 · Cited by 20
Lessons to be Learned from Placebo Arms in Psychopharmacology Trials
Doering, B. K., Rief, W., & Petrie, K. J. (2014) · Handbook of experimental pharmacology · doi:10.1007/978-3-662-44519-8_15 · Cited by 18
An introduction to adaptive designs and adaptation in CNS trials
Dragalin, V. (2010) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2010.09.004 · Cited by 18
Factors shaping expectations for complete relief from symptoms during rehabilitation for patients with spine pain
Bishop, M. D., Mintken, P. E., Bialosky, J. E., & Cleland, J. A. (2018) · Physiotherapy Theory and Practice · doi:10.1080/09593985.2018.1440676 · Cited by 17
Rigorous Trial Design Is Essential to Understand the Role of Opioid Receptors in Ketamine’s Antidepressant Effect
Heifets, B. D., Williams, N., Bentzley, B. S., & Schatzberg, A. F. (2019) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2019.0766 · Cited by 17
Self-citation
Working alliance as a mediator and moderator between expectations for counseling success and counseling outcome among Korean clients
Yoo, S., Hong, S., Sohn, N., & O’Brien, K. M. (2014) · Asia Pacific Education Review · doi:10.1007/s12564-014-9320-2 · Cited by 14
Placebo Response Reduction and Accurate Pain Reporting Training Reduces Placebo Responses in a Clinical Trial on Chronic Low Back Pain
Erpelding, N., Evans, K., Lanier, R. K., Elder, H., & Katz, N. P. (2020) · Clinical Journal of Pain · doi:10.1097/ajp.0000000000000873 · Cited by 14
Can MDMA Change Sociopolitical Values? Insights From a Research Participant
de Wit, H., Bershad, A. K., Hutchison, W., & Bremmer, M. P. (2021) · Biological Psychiatry · doi:10.1016/j.biopsych.2021.01.016 · Cited by 10
Placebo
Benedetti, F., & Schedlowski, M. (2014) · Handbook of Experimental Pharmacology · doi:10.1007/978-3-662-44519-8 · Cited by 8
Anne Hamilton-Byrne and the Family
Cusack, C. M. (2020) · Nova Religio The Journal of Alternative and Emergent Religions · doi:10.1525/nr.2020.24.1.31 · Cited by 4
Can sequential parallel comparison design and two-way enriched design be useful in medical device clinical trials?
Ivanova, A., Zhang, Z., Thompson, L., Yang, Y., Kotz, R. M., & Fang, X. (2015) · Journal of Biopharmaceutical Statistics · doi:10.1080/10543406.2015.1092028 · Cited by 3
Aum shinrikyo
Kogo, Y. (2003) · Self & Society · doi:10.1080/03060497.2003.11086195 · Cited by 2

Research works printed but not linked: 4

Aday JS (2021) Delineating the association between psychedelic drug use and facets of gratitude, aesthetic experience, and relationships with nature. Dissertation, Central Michigan University
Doblin R (1991) Pahnke’s “Good Friday experiment”: a long-term follow-up and methodological critique. J Transpers Psychol 23:1–28
Pahnke WN (1963) Drugs and mysticism: an analysis of the relationship between psychedelic drugs and the mystical consciousness: a thesis. Dissertation. Harvard University
Puente I (2014) Holotropic breathwork can occasion mystical experiences in the context of a daylong workshop. J Transper Res 6:40–50

Sorted by citations

Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
Raison, C. L., Sanacora, G., Woolley, J., Heinzerling, K., Dunlop, B. W., Brown, R. T., Kakar, R., Hassman, M., Trivedi, R. P., Robison, R., et al. (2023) · JAMA · doi:10.1001/jama.2023.14530 · Cited by 545
Self-citation
Pharmacological, neural, and psychological mechanisms underlying psychedelics: A critical review
van Elk, M., & Yaden, D. B. (2022) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2022.104793 · Cited by 221
Adverse events in clinical treatments with serotonergic psychedelics and MDMA: a mixed-methods systematic review.
Breeksema, J. J., Kuin, B. W., Kamphuis, J., van den Brink, W., Vermetten, E., & Schoevers, R. A. (2022) · Journal of Psychopharmacology · doi:10.1177/02698811221116926 · Cited by 178
Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial
Sloshower, J., Skosnik, P. D., Safi-Aghdam, H., Pathania, S., Syed, S., Pittman, B., & D’Souza, D. C. (2023) · Journal of Psychopharmacology · doi:10.1177/02698811231154852 · Cited by 165
Clinical applications and therapeutic potentials of advanced nanoparticles: a comprehensive review on completed human clinical trials
Kumarasamy, R. V., Natarajan, P. M., Umapathy, V. R., Roy, J. R., Mironescu, M., & Palanisamy, C. P. (2024) · Frontiers in Nanotechnology · doi:10.3389/fnano.2024.1479993 · Cited by 154

See all 237

Authors: Aday, J. S., Heifets, B. D., Pratscher, S. D., Bradley, E., Rosen, R., & Woolley, J. D.
Affiliations: San Francisco VA Medical Center (US)
Stanford Medicine (US)
University of Florida Health (US)
Corresponding author: Aday, Jacob S.
Heifets, Boris D.
Pratscher, Steven D.
Bradley, Ellen
Rosen, Raymond
Woolley, Joshua D.
ORCID: Aday, Jacob S.
Heifets, Boris D.
Pratscher, Steven D.
Bradley, Ellen
Woolley, Joshua D.
Venue: Psychopharmacology
Publisher: Springer Science and Business Media LLC
Published: 2022-04-01
Volume: 239
Issue: 6
Pages: 1989-2010
ISSN: 0033-3158 (ISSN-L)
1432-2072
DOI: 10.1007/s00213-022-06123-7
PMC: PMC10184717
OpenAlex: W4226207502
Cited by: 237
References: 174
Citations by year: 2026: 49 · 2025: 59 · 2024: 64 · 2023: 47 · 2022: 18
FWCI: 7.84
Type: journal article
Language: en
Open access: green
doi.org
Licence: public-domain
www.springer.com/tdm (tdm)
www.springer.com/tdm (vor)
Locations: Psychopharmacology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
PsyArXiv (OSF Preprints) (submittedVersion)
PsyArXiv (OSF Preprints) (submittedVersion, public-domain)
Funders: U.S. Department of Veterans Affairs (IK4 CX002090)
University of California, San Francisco
National Institute on Aging (T32AG049673)
Topics: Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: placebo effect, nocebo effect, expectancy effects, active placebo, treatment expectations, bias mitigation, research design, participant recruitment
MeSH terms: Hallucinogens, Humans, Motivation, Psychotherapy, Research Design

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Claims other papers make about this one

Self-check

Citations

Cites

Cited by

Related

Metadata

Record

About these checks