Cited by 245Substance Abuse Treatment and OutcomesOpioid Use Disorder TreatmentNeurotransmitter Receptor Influence on Behavior

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Dextroamphetamine for Cocaine-Dependence Treatment: A Double-Blind Randomized Clinical Trial

Grabowski, John, Rhoades, Howard, Schmitz, Joy, Stotts, Angela, Daruzska, Lee Ann, Creson, Dan, Moeller, F. Gerard·2001·Journal of Clinical Psychopharmacology

DOI 10.1097/00004714-200110000-00010

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Abstract

A properly implemented agonist treatment regimen should improve retention and reduce illicit drug use. Cocaine-dependent subjects (N = 128) were enrolled in a 12-week randomized, double-blind, placebo-controlled trial. In the multistage dosing design, subjects initially received placebo (PBO) or 15 to 30 mg of dextroamphetamine sulfate, sustained-release capsules. At week 5, the dose doubled to 30 mg or 60 mg for active groups. Subjects attended the clinic twice a week, provided urine samples, obtained medication, and had one behavioral therapy session a week. Retention was best for the 15- to 30-mg group, whereas the proportion of benzoylecgonine-positive urine screens was, from lowest to highest, 30 to 60 mg, 15 to 30 mg, and PBO at study end. Dosing must be refined. The results provide support for additional examination of the agonist model in psychostimulant-dependence treatment.

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BackgroundMethodResultInfluential
Abuse-Related Effects of Dual Dopamine/Serotonin Releasers with Varying Potency to Release Norepinephrine in Male Rats and Rhesus Monkeys
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“Statistical analyses in preclinical addiction medication research Pharmacological treatment effects on cocaine self-administration were evaluated using a ramping, subchronic dosing regimen to model dosing regimens used in clinical trials (Grabowski et al., 2001, 2004).”
BackgroundMethodInfluential
Methylphenidate effective in treating amphetamine abusers with no other psychiatric disorder
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Background
Effects of methcathinone and 3-Cl-methcathinone (PAL-434) in cocaine discrimination or self-administration in rhesus monkeys
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“Since a number of groups have suggested that other agonist-like medications, such as modafinil and methylphenidate, may have utility as cocaine treatment medications (e.g., Dackis et al., 2003, 2005; Grabowski et al., 2001; Mariani and Levin, 2012; Martínez-Raga et al., 2008; Vansickel et al., 2008; Winhusen et al., 2…”
Background
Attenuation of cocaine self-administration by chronic oral phendimetrazine in rhesus monkeys
Czoty, P., Blough, B., Fennell, T., Snyder, R. W., & Nader, M. A. (2016) · Neuroscience · doi:10.1016/j.neuroscience.2016.03.002 · Cited by 11
“Moreover, clinical studies have supported the safety and efficacy of amphetamine and its analogs as a treatment for cocaine use disorders, including multiple double-blind, placebo-controlled studies (Grabowski et al., 2001, 2004b; Shearer et al., 2003; Mooney et al., 2009; Levin et al., 2015).”
Background
Effects of 7-day continuous d-amphetamine, methylphenidate, and cocaine treatment on choice between methamphetamine and food in male rhesus monkeys
Schwienteck, K. L., & Banks, M. (2015) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2015.08.022 · Cited by 13
“A more recent example of this reverse translation approach might be the demonstration of amphetamine treatment efficacy for cocaine addiction (Grabowski et al., 2001; Negus, 2003).”
Background
Potential effect of antidepressants on remission from cocaine use disorder – A nationwide matched retrospective cohort study
Gao, Z., Winhusen, T. M., Gorenflo, M. P., Ghitza, U. E., Nunes, E. V., Saxon, A. J., Korthuis, P. T., Brady, K. T., Luo, S. X., Davis, P. B., et al. (2023) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2023.110958 · Cited by 14
Reduction of the reinforcing effectiveness of cocaine by continuous d-amphetamine treatment in rats: importance of active self-administration during treatment period
Zimmer, B. A., Chiodo, K. A., & Roberts, D. (2013) · Psychopharmacology · doi:10.1007/s00213-013-3305-4 · Cited by 15
“Self-administration”
Background
A mechanistic overview of approaches for the treatment of psychostimulant dependence
Jensen, K. L., Jensen, S. B., & Madsen, K. L. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.854176 · Cited by 12
Distinguishing Symptoms of ADHD from Other Psychiatric Disorders in the Adult Primary Care Setting
Montano, C. B., & Weisler, R. H. (2011) · Postgraduate Medicine · doi:10.3810/pgm.2011.05.2287 · Cited by 11
Can pharmacotherapy improve treatment outcomes in people with co-occurring major depressive and cocaine use disorders?
Angarita, G. A., Hadizadeh, H., Cerdena, I. L., & Potenza, M. N. (2021) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2021.1931684 · Cited by 11
Identification of Treatment Targets in a Genetic Mouse Model of Voluntary Methamphetamine Drinking
Phillips, T. J., Mootz, J. R. K., & Reed, C. L. (2016) · International review of neurobiology · doi:10.1016/bs.irn.2016.02.001 · Cited by 12
Co-targeting the kappa opioid receptor and dopamine transporter reduces motivation to self-administer cocaine and partially reverses dopamine system dysregulation
Estave, P. M., Albertson, S. E., Karkhanis, A. N., & Jones, S. R. (2024) · Scientific Reports · doi:10.1038/s41598-024-53463-9 · Cited by 11
Safety and tolerability of intranasal cocaine during phendimetrazine maintenance
Stoops, W. W., Strickland, J., Hays, L., Rayapati, A., Lile, J., & Rush, C. (2016) · Psychopharmacology · doi:10.1007/s00213-016-4260-7 · Cited by 9
“…reduces cocaine self-administration in rats, monkeys, and humans (Greenwald et al. 2010; Negus and Mello 2003a, b; Rush et al. 2010; Thomsen et al. 2013) and also reduces the number of cocaine-positive urine samples provided by patients enrolled in clinical trials (Grabowski et al. 2001, 2004b).”
Modulation of striatal dopamine dynamics by cocaine self-administration and amphetamine treatment in female rats
Siciliano, C. A., Mauterer, M. I., Fordahl, S., & Jones, S. R. (2019) · European Journal of Neuroscience · doi:10.1111/ejn.14437 · Cited by 12
“These findings were supported and extended by two larger clinical trials conducted by Grabowski and colleagues in which AMPH was administered on an outpatient basis for 12 (Grabowski et al., 2001) or 24 (Grabowski, Rhoades, et al.”
Result
EVALUATION OF DRUG ABUSE TREATMENT MEDICATIONS: CONCORDANCE BETWEEN CLINICAL AND PRECLINICAL STUDIES.
Mello, N. K. (2005) · PubMed · Cited by 11
A randomized, double-blind, placebo-controlled trial of ondansetron for the treatment of cocaine use disorder with post hoc pharmacogenetic analysis
Blevins, D., Seneviratne, C., Wang, X.-Q., Johnson, B. A., & Ait‐Daoud, N. (2021) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2021.109074 · Cited by 11
Impulsiveness as a moderator of amphetamine treatment response for cocaine use disorder among ADHD patients
Blevins, D., Choi, C. J., Pavlicova, M., Martinez, D., Mariani, J., Grabowski, J., & Levin, F. R. (2020) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2020.108082 · Cited by 10
Self-citation
Effects of the dopamine/norepinephrine releaser phenmetrazine on cocaine self-administration and cocaine-primed reinstatement in rats
Czoty, P., Tran, P. K., Thomas, L. N., Martin, T. J., Grigg, A., Blough, B., & Beveridge, T. J. R. (2015) · Psychopharmacology · doi:10.1007/s00213-015-3875-4 · Cited by 8
Maintenance on naltrexone + amphetamine decreases cocaine-vs.-food choice in male rhesus monkeys
Moerke, M. J., Banks, M. L., Cheng, K., Rice, K. C., & Negus, S. S. (2017) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2017.09.020 · Cited by 10
“Furthermore, clinical trials have demonstrated the effectiveness of amphetamine maintenance to decrease metrics of cocaine use in cocaine-dependent patients (Grabowski et al., 2001; Mariani et al., 2012; Nuijten et al., 2016; Perez-Mana et al., 2011).”
Background
Using Ca2+-channel biosensors to profile amphetamines and cathinones at monoamine transporters: electro-engineering cells to detect potential new psychoactive substances
Steele, T. W. E., & Eltit, J. M. (2018) · Psychopharmacology · doi:10.1007/s00213-018-5103-5 · Cited by 10
Evaluation of the Reinforcing Strength of Phendimetrazine Using a Progressive-Ratio Schedule of Reinforcement in Rhesus Monkeys
Minkiewicz, M., Czoty, P. W., Blough, B. E., & Nader, M. A. (2020) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.120.264952 · Cited by 10
“For example, clinical and preclinical studies have consistently demonstrated that d-amphetamine reduces the reinforcing and subjective effects of cocaine (e.g., Grabowski et al., 2001; Negus and Mello, 2003; Chiodo and Roberts, 2009; Rush et al., 2009; Czoty et al., 2010, 2011, 2016b).”
Result
Chapter 19. Dual dopamine/serotonin releasers as potential medications for stimulant and alcohol addictions
Rothman, R., Blough, B., & Baumann, M. (2008) · Springer eBooks · doi:10.1007/978-0-387-76678-2_19 · Cited by 1
Contrasting the reinforcing effects of the novel dopamine transport inhibitors JJC8-088 and JJC8-091 in monkeys: Potential translation to medication assisted treatment
Allen, M. I., Rahimi, O., Johnson, B., Cao, J., Newman, A. H., & Nader, M. A. (2024) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.124.002356 · Cited by 9
The effects of combination levodopa-ropinirole on cognitive improvement and treatment outcome in individuals with cocaine use disorder: A bayesian mediation analysis.
Schmitz, J. M., Suchting, R., Green, C., Webber, H. E., Vincent, J., Moeller, F., & Lane, S. (2021) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2021.108800 · Cited by 6
Self-citation
Treating adult attention deficit hyperactivity disorder in hospitalized psychiatric patients.
Castaneda, R., Levy, R. H., Hazzi, C., Ross, S., Roman, W., & Hamid, H. (2008) · General Hospital Psychiatry · doi:10.1016/j.genhosppsych.2008.08.006 · Cited by 9
“[29] Grabowski J, Rhoades H, Schmitz J, Stotts A, et al.”
Background
Substitution therapy with amphetamine-isotherapic attenuates amphetamine toxicological aspects of addiction
Segat, H. J., Metz, V. G., Rosa, H. Z., Dias, V. T., Barcelos, R. C. S., Dolci, G. S., & Bürger, M. E. (2018) · Neuroscience Letters · doi:10.1016/j.neulet.2018.10.007 · Cited by 9
Commissioning pharmacological treatments for drug users: a brief review of the evidence base
Keen, J., & Oliver, P. (2004) · Drugs Education Prevention and Policy · doi:10.1080/0968763031000075906 · Cited by 9
“Such treatments may include specialist interventions such as dexamphetamine (Grabowski et al., 2001) and amelioration of withdrawal symptoms with SSRIs such as fluoxetine and/or short-term benzodiazepines.”
Background
Emerging medications and pharmacological treatment approaches for substance use disorders
Raymond, J. S., Athanasopoulos, A. G., Badolato, C. J., Doolan, T. M., Scicluna, R. L., Everett, N. A., Bowen, M. T., & James, M. H. (2024) · Pharmacology Biochemistry and Behavior · doi:10.1016/j.pbb.2024.173952 · Cited by 9
“The rationale behind psychostimulant-based treatments for StUDs mirrors the rationale of agonist therapies for opioid use disorder and nicotine use disorder (as described in the Introduction ) (Herin et al., 2010; Grabowski et al., 2001).”
The utility of ?tolerance? as a concept in the study of drug self-administration
Negus, S. S., Mello, N. K., & Caine, S. B. (2004) · Psychopharmacology · doi:10.1007/s00213-003-1606-8 · Cited by 8
“Moreover, both our data and recent clinical studies (Grabowski et al. 2001) suggest that chronic exposure to amphetamine may also produce tolerance-like decreases in the reinforcing effects of cocaine and may be useful in the treatment of cocaine dependence.”
Delta Opioids and Substance Abuse
Negus, S. S. (2003) · CRC Press eBooks · doi:10.1201/9780203025765.ch23 · Cited by 8
Role of d -amphetamine and d -methamphetamine as active metabolites of benzphetamine: Evidence from drug discrimination and pharmacokinetic studies in male rhesus monkeys
Banks, M. L., Snyder, R. W., Fennell, T. R., & Negus, S. S. (2017) · Pharmacology Biochemistry and Behavior · doi:10.1016/j.pbb.2017.03.008 · Cited by 7
Mixed amphetamine salts–extended release (MAS-ER) as a behavioral treatment augmentation strategy for cocaine use disorder: A randomized clinical trial.
Carpenter, K. M., Choi, C. J., Basaraba, C. N., Pavlicová, M., Brooks, D. J., Brezing, C., Bisaga, A. M., Nunes, E. V., Mariani, J. J., & LEVIN, F. R. (2023) · Experimental and Clinical Psychopharmacology · doi:10.1037/pha0000676 · Cited by 6
Clinical Trials for Stimulant Use Disorders: Addressing Heterogeneities That May Undermine Treatment Outcomes
Regier, P. S., Kampman, K. M., & Childress, A. R. (2019) · Handbook of experimental pharmacology · doi:10.1007/164_2019_303 · Cited by 7
Identification of key genes and therapeutic drugs for cocaine addiction using integrated bioinformatics analysis
Wang, X., Sun, S., Chen, H., Yun, B., Zhang, Z., Wang, X., Wu, Y., Lv, J., He, Y., Wan, L., et al. (2023) · Frontiers in Neuroscience · doi:10.3389/fnins.2023.1201897 · Cited by 5
“Dextroamphetamine, a central nervous system stimulant, has been found to be a treatment for cocaine dependence (Grabowski et al., 2001; Shearer et al., 2003; Palis et al., 2021; Ndiaye et al., 2022).”
Background
The potential of pharmacogenomics to treat drug addiction.
Haile, C., & Kosten, T. (2009) · Pharmacogenomics (London) · doi:10.2217/pgs.09.146 · Cited by 7
Methamphetamine Cured my Cocaine Addiction
Haile, C. N., Garza, R. D. L., & Newton, T. F. (2010) · Journal of Addiction Research & Therapy · doi:10.4172/2155-6105.1000103 · Cited by 5
“These cases appear to support preclinical and clinical studies suggesting that chronic treatment with AMPH-like stimulants— such as METH—may be efficacious for cocaine dependence [11,14].”
Result
Dexamphetamine substitute‐prescribing in pregnancy: a 10‐year retrospective audit
White, R., Thompson, M., Windsor, D., Walsh, M., Cox, D., & Charnaud, B. (2006) · Journal of Substance Use · doi:10.1080/14659890600594112 · Cited by 5
Behavioral Studies in Nonhuman Primates: Focus on Models of Substance Use Disorders
Johnson, B., Norman, C., Minkiewicz, M., & Nader, M. A. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-809324-5.23967-9 · Cited by 5
The Novel N-Substituted Benztropine Analog GA2-50 Possesses Pharmacokinetic and Pharmacodynamic Profiles Favorable for a Candidate Substitute Medication for Cocaine Abuse
Othman, A. A., Newman, A., & Eddington, N. (2008) · Journal of Pharmacy and Science · doi:10.1002/jps.21389 · Cited by 4
Opening the Cocaine Economy by Providing Within-session Access to a Cheaper Source of Cocaine Makes Demand for it More Elastic
Kearns, D., & Silberberg, A. (2019) · Behavioural Pharmacology · doi:10.1097/fbp.0000000000000510 · Cited by 2
An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders
Blevins, D., Carpenter, K. M., Martínez, D., Mariani, J. J., & LEVIN, F. R. (2020) · Contemporary Clinical Trials · doi:10.1016/j.cct.2020.106187 · Cited by 4
“showed improvements in cocaine use that were moderated by medication dose, with higher-dose d-amphetamine groups having more cocaine-negative urines and all doses resulting in more improvement compared to placebo [44].”
Result
D-amphetamine maintenance therapy reduces cocaine use in female rats
Ndiaye, N. A., Allain, F., & Samaha, A. (2022) · Psychopharmacology · doi:10.1007/s00213-022-06271-w · Cited by 4
“In parallel, while some studies in humans and nonhuman primates have included females, results were not analysed by sex (Grabowski et al., 2001; Greenwald et al., 2010; Lile et al., 2020; Negus & Mello, 2003; Rush et al., 2010, 2009), arguably becausemany of these studies were not sufficiently powered to do so.”
BackgroundResultInfluential
Role of the Human Laboratory in the Development of Medications for Alcohol and Drug Dependence
Roache, J. D. (2010) · Springer eBooks · doi:10.1007/978-1-4419-0338-9_7 · Cited by 4

Authors: Grabowski, J., Rhoades, H., Schmitz, J., Stotts, A., Daruzska, L. A., Creson, D., & Moeller, F. G.
ORCID: Schmitz, Joy
Stotts, Angela
Moeller, F. Gerard
Venue: Journal of Clinical Psychopharmacology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2001-10
Volume: 21
Issue: 5
Pages: 522-526
ISSN: 0271-0749 (ISSN-L)
DOI: 10.1097/00004714-200110000-00010
OpenAlex: W2052304909
Cited by: 243
References: 22
Citations by year: 2026: 3 · 2025: 3 · 2024: 10 · 2023: 7 · 2022: 5 · 2021: 12 · 2020: 10 · 2019: 8 · 2018: 9 · 2017: 6 · 2016: 14 · 2015: 13 · 2014: 12 · 2013: 11 · 2012: 13
FWCI: 7.78
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Psychopharmacology (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health (5p50da009262-20)
National Institute on Drug Abuse (DA RO1-6143, DA P50-9262)
Topics: Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
Keywords: d-amphetamine, cocaine dependence, treatment retention, illicit drug use, dose escalation, urine drug testing, benzoylecgonine, stimulant use disorder, behavior therapy
MeSH terms: Adult, Central Nervous System Stimulants, Behavior Therapy, Cocaine, Delayed-Action Preparations, Dextroamphetamine, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Patient Compliance, Patient Dropouts, Severity of Illness Index, Substance Abuse Detection, Cocaine-Related Disorders

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Dextroamphetamine for Cocaine-Dependence Treatment: A Double-Blind Randomized Clinical Trial

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