Recommendation for the assessment of tobacco craving and withdrawal in smoking cessation trials
Abstract
This paper addresses methodological issues in the assessment of nicotine withdrawal and craving in clinical trials of smoking cessation therapies. We define withdrawal as a syndrome of behavioral, affective, cognitive, and physiological symptoms, typically transient, emerging upon cessation or reduction of tobacco use and causing distress or impairment of behavioral function. Offset effects (effects related to removal of a direct nicotine effect) are sustained effects of cessation or reduction of tobacco use that cause distress or impairment. Withdrawal and craving are important as potential predictors of relapse, as mediators and markers of treatment effects, and as clinical phenomena in their own right. Symptoms recommended for assessment include craving, irritability, depression, restlessness, sleep disturbance, difficulty concentrating, increased appetite, and weight gain; anxiety deserves further study. We recommend reporting of data on each of these individual symptoms, and use of multiple-item assessments. Although some standardized measures of withdrawal have promising psychometric properties, no measure has yet fully established its reliability, validity, and broad applicability and, therefore, we do not currently favor universal adoption of any one measure. Assessment of objective indices of withdrawal (e.g., hormonal changes) is currently technically challenging and of unknown value. Although weekly assessment may suffice in some large trials, more intensive measurement can provide better sensitivity. Analyses of withdrawal should include baseline measures and be sensitive to potential instability in baseline. Analytic approaches should take into account potential bias when only abstinent subjects are examined. Conversely, heterogeneity should be considered when smoking subjects are included in intent-to-treat analyses. Withdrawal data from clinical trials focused on assessing abstinence rates may be biased because of progressive subject loss to dropout and relapse; different designs and approaches are needed to investigate the process and natural history of craving and withdrawal.
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Withdrawal following smoking cessation is acutely associated with heightened levels of stress and negative affect.
“Withdrawal following smoking cessation is acutely associated with heightened levels of stress and negative affect (Shiffman 2004; West 2017).”
From Mindfulness for smoking cessation (2022) · cites this paper as Shiffman 2004
Early stage acute stress, negative affect, and depression are predictive of relapse.
“but early stage acute stress, negative affect, and depression are predictive of relapse (Correa‐Fernández 2012; Glassman 1990; Shiffman 2004; Shiffman 2005).”
From Mindfulness for smoking cessation (2022) · cites this paper as Shiffman 2004
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“The negative effects of nicotine withdrawal account, in part, for low success rates.(2,3) Approved pharmacotherapies to treat nicotine dependence (eg, nicotine replacement therapy and bupropion) have had important, albeit moderate, efficacy, with reported rates of quitting generally twice those of placebo.”
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“The Wisconsin Smoking Withdrawal Scale (WSWS) measures severity of smoking withdrawal and exhibits good validity and reliability in smoking cessation studies (Shiffman et al., 2004; Welsch et al., 1999).”
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“and there is a lack of internationally certified manufacturing sites. Regulators also lack data on the ability of ENDDs to relieve the desire to smoke cigarettes and to suppress other tobacco withdrawal symptoms. Study designs that assess change in subjective withdrawal symptoms have been used to evaluate the utility…”
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“Thus, within hours upon cessation of nicotine exposure, a nicotine withdrawal syndrome emerges characterized by depressed mood, irritability, mild cognitive deficits and physiological symptoms (Shiffman et al. 2004).”
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“However, even if some of the group differences observed in the current study represent offset effects rather than withdrawal, these effects should not be discounted, as withdrawal and offset effects have equal potential to cause distress and motivate cigarette use (e.g., Hughes et al. 1990; Shiffman et al. 2004).”
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“and gradually wane to pre-cessation levels after 2–4 weeks, although cravings often continue.(54)”
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“However, most research shows that craving reports typically escalate in response to tobacco abstinence and are significantly associated with other elements of that syndrome [78, 86–89].”
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“Finally, craving has also largely been studied using single-item measures, which have several psychometric limitations compared with multi-item measures (Rosenberg, 2009; Sayette et al., 2000; Shiffman et al., 2004; Tiffany, 1992; Tiffany, Carter, & Singleton, 2000).”
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“Relevant variations may be the scales used, the frequency of assessments of craving and withdrawal symptoms, the intensity of craving and withdrawal symptoms, the out-patient vs laboratorybased nature of the studies, or other fundamental differences in study design (Hughes et al. 1984; Schneider and Jarvik 1984; Schne…”
BackgroundHeckman, B. W., MacQueen, D. A., Marquinez, N. S., MacKillop, J., Bickel, W. K., & Brandon, T. H. (2017) · Journal of Consulting and Clinical Psychology · doi:10.1037/ccp0000197 · Cited by 39 · see citing works
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“Withdrawal and craving symptoms—Within the app, participants rated their average withdrawal symptoms and cravings at the end of each day using a five-point rating scale of severity [79, 80].”
MethodLiakoni, E., Edwards, K. C., Helen, G. S., Nardone, N., Dempsey, D. A., Tyndale, R. F., & Benowitz, N. L. (2018) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1238 · Cited by 37 · see citing works
“Withdrawal symptoms can present a major obstacle to smoking cessation and increase relapse risk.(26,27) Therefore, specific supporting measures (e.”
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Reduction in Cortisol After Smoking Cessation Among Users of Nicotine Patches
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Self-citationDistress intolerance during smoking cessation treatment
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Begh, R. A., Munafo, M. R., Shiffman, S. S., Ferguson, S. G., Nichols, L., Mohammed, M. A., HOLDER, R. L., Sutton, S. R., & Aveyard, P. N. (2015) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2015.01.041 · Cited by 34 · see citing works
“For withdrawal analyses, we followed recommendations of the Society for Research on Nicotine and Tobacco work group (Shiffman et al., 2004) and performed analyses initially in abstainers only and then by intention-to treat (ITT).”
MethodSelf-citationKlein, E. G., Quisenberry, A. J., Shoben, A. B., Cooper, S., Ferketich, A. K., Berman, M. L., Peters, E. M., & Wewers, M. E. (2017) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntx021 · Cited by 32 · see citing works
Gilbert, D. G., Zuo, Y., Rabinovich, N. E., Riise, H., Needham, R., & Huggenvik, J. I. (2009) · Journal of Abnormal Psychology · doi:10.1037/a0015382 · Cited by 32 · see citing works
“The observed ability of trait anger and depression to predict abstinence-induced increases in state anger-irritability and depression (respectively) above and beyond the assessed genotypes is consistent with the view that TAS trajectories are determined by multiple genetic, situational, and historical factors (Shiffma…”
ResultSelf-citationMarkov model of smoking cessation
Killeen, P. R. (2011) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1011277108 · Cited by 31 · see citing works
Smoking cessation behaviors three months following acute insular damage from stroke
Abdolahi, A., Williams, G. C., Benesch, C. G., Wang, H. Z., Spitzer, E. M., Scott, B. E., Block, R., & van Wijngaarden, E. (2015) · Addictive Behaviors · doi:10.1016/j.addbeh.2015.07.001 · Cited by 32 · see citing works
“To distinguish urge from cessation, these two constructs must be measured separately [26].”
BackgroundMistry, R., Jones, A. D., Pednekar, M. S., et al. (2018) · Reproductive Health · doi:10.1186/s12978-018-0516-5 · Cited by 31 · see citing works
“Behaviorally, tobacco use may act as an appetite suppressant [15–17], and has been linked with lower food intake and household food insecurity [18–20], while tobacco abstinence may increase appetite [16, 21].”
BackgroundSmoCuDa: A Validated Smoking Cue Database to Reliably Induce Craving in Tobacco Use Disorder
Manoliu, A., Haugg, A., Sladky, R., Hulka, L. M., Kirschner, M., Brühl, A. B., Seifritz, E., Quednow, B. B., Herdener, M., & Scharnowski, F. (2020) · European Addiction Research · doi:10.1159/000509758 · Cited by 29 · see citing works
Chatterjee, S., Hovsepian, K., Sarker, H., Saleheen, N., Al’Absi, M., Atluri, G., Ertin, E., Lam, C. Y., Lemieux, A. M., Nakajima, M., et al. (2016) · ACM International Joint Conference on Pervasive and Ubiquitous Computing (UbiComp) · doi:10.1145/2971648.2971672 · Cited by 30 · see citing works
“Smoking researchers have envisioned [37,43] the use of ubiquitous computing (e.”
BackgroundAcupressure for smoking cessation – a pilot study
White, A. R., Moody, R. C., & Campbell, J. L. (2007) · BMC Complementary and Alternative Medicine · doi:10.1186/1472-6882-7-8 · Cited by 30 · see citing works
Nicotine Withdrawal Symptoms in Adolescent and Adult Twins
Pergadia, M. L., Arpana Agrawal, A., Heath, A. C., Martin, N. G., Bucholz, K. K., & Madden, P. A. F. (2010) · Twin Research and Human Genetics · doi:10.1375/twin.13.4.359 · Cited by 30 · see citing works
“…symptoms associated with nicotine abstinence, particularly DSM-IV nicotine withdrawal symptoms (Hughes, 2007a; Hughes, 2007b; Hughes, 2007c; Shiffman et al., 2004) the predominate method of examining the symptoms of nicotine withdrawal symptoms has been to explore the factor structure or…”
BackgroundMethodShiffman, S. (2008) · Clinical Therapeutics · doi:10.1016/j.clinthera.2008.07.019 · Cited by 29 · see citing works
Self-citationMead, E. L., Chen-Sankey, J. C., Kirchner, T., et al. (2018) · Nicotine & Tobacco Research · doi:10.1093/ntr/nty061 · Cited by 28 · see citing works
Higher fasting ghrelin serum levels in active smokers than in former and never-smokers
Wittekind, D. A., Kratzsch, J., Mergl, R., Enzenbach, C., Witte, A. V., Villringer, A., & Kluge, M. (2019) · The World Journal of Biological Psychiatry · doi:10.1080/15622975.2019.1671610 · Cited by 27 · see citing works
Farris, S. G., Zvolensky, M. J., Otto, M. W., & Leyro, T. M. (2015) · Journal of Psychopharmacology · doi:10.1177/0269881115575536 · Cited by 25 · see citing works
“24 hours after quitting) can be conceptualized as critical ‘window’ for experiencing acute distress (Shiffman et al., 2004).”
BackgroundSeverity of tobacco abstinence symptoms varies by time of day
Perkins, K. A., Briski, J. L., Fonte, C. A., Scott, J., & Lerman, C. E. (2009) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntn003 · Cited by 26 · see citing works
Time to Reconsider the Role of Craving in Opioid Use Disorder
Kleykamp, B. A., Weiss, R. D., & Strain, E. C. (2019) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2019.1839 · Cited by 26 · see citing works
Parsons, A. C., Ingram, J. T., Inglis, J., Aveyard, P. N., Johnstone, E. C., Brown, K. S., Franklin, M., & Bermúdez, I. (2009) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2009.02.006 · Cited by 24 · see citing works
“only (Shiffman et al., 2004), which we defined as CO reading less than 10ppm at the relevant visit, which avoided excluding many participants.”
BackgroundSmith, A. E., Cavallo, D. A., McFetridge, A. K., Liss, T. B., & Krishnan‐Sarin, S. (2008) · Nicotine & Tobacco Research · doi:10.1080/14622200802219357 · Cited by 24 · see citing works
Characterizing nicotine withdrawal in pregnant cigarette smokers.
Heil, S. H., Higgins, S. T., Mongeon, J. A., Badger, G. J., & Bernstein, I. M. (2006) · Experimental and Clinical Psychopharmacology · doi:10.1037/1064-1297.14.2.165 · Cited by 23 · see citing works
Linke, S., Rutledge, T. R., & Myers, M. G. (2012) · Mental health and physical activity · doi:10.1016/j.mhpa.2012.02.001 · Cited by 24 · see citing works
Health behaviors among testicular cancer survivors
Reilley, M. J., Jacobs, L. A., Vaughn, D. J., & Palmer, S. C. (2014) · The Journal of Community and Supportive Oncology · doi:10.12788/jcso.0033 · Cited by 22 · see citing works
Possible New Symptoms of Tobacco Withdrawal II: Anhedonia—A Systematic Review
Hughes, J. R., Klemperer, E. M., & Peasley‐Miklus, C. (2018) · Nicotine & Tobacco Research · doi:10.1093/ntr/nty171 · Cited by 23 · see citing works
Shiffman, S. S., & Ferguson, S. G. (2008) · Current Medical Research and Opinion · doi:10.1185/03007990802380341 · Cited by 22 · see citing works
Self-citationRogers, A. H., Bakhshaie, J., Garey, L., Piasecki, T. M., Gallagher, M. W., Schmidt, N. B., & Zvolensky, M. J. (2018) · Behaviour Research and Therapy · doi:10.1016/j.brat.2018.10.007 · Cited by 22 · see citing works
Tønnesen, P., & Mikkelsen, K. L. (2012) · Nicotine & Tobacco Research · doi:10.1093/ntr/nts146 · Cited by 20 · see citing works
- Authors
- Shiffman, S., West, R., & Gilbert, D.
- Affiliations
- University of Pittsburgh (US)
- St George's, University of London (GB)
- Southern Illinois University Carbondale (US)
- Corresponding author
- Shiffman, Saul
- Venue
- Nicotine & Tobacco Research
- Publisher
- Oxford University Press (OUP)
- Published
- 2004-08-01
- Volume
- 6
- Issue
- 4
- Pages
- 599-614
- ISSN
- 1462-2203 (ISSN-L)
- 1469-994X
- OpenAlex
- W1971596397
- Cited by
- 255
- References
- 0
- Citations by year
- 2026: 6 · 2025: 8 · 2024: 8 · 2023: 9 · 2022: 10 · 2021: 16 · 2020: 7 · 2019: 9 · 2018: 14 · 2017: 8 · 2016: 14 · 2015: 10 · 2014: 9 · 2013: 11 · 2012: 15
- FWCI
- 6.99
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Nicotine & Tobacco Research (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Prenatal Substance Exposure Effects
- Keywords
- cigarette craving, nicotine withdrawal, smoking cessation, recurrence prediction, reliability and validity, intention-to-treat analysis
- MeSH terms
- Clinical Trials as Topic, Data Collection, Ganglionic Stimulants, Humans, Nicotine, Terminology as Topic, Patient Dropouts, Recurrence, Research Design, Substance Withdrawal Syndrome, Tobacco Use Disorder, Smoking Cessation, Endpoint Determination
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.
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