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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 (Shiffman 2004; West 2017).”
From Mindfulness for smoking cessation (2022) · cites this paper as Shiffman 2004
In the citing paper
“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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Items 101–200 of 255
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“In keeping with consensus guidelines, we analysed withdrawal phenomena only in those who were abstinent, defined as an exhaled CO<10 ppm[18].”
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Munafo, M., & Hitsman, B. (2010) · Addiction · doi:10.1111/j.1360-0443.2010.03127.x · Cited by 9
“While it is widely assumed that cravings may precipitate relapse to smoking, measures of self-reported craving predict relapse only weakly, particularly when measured at a single time-point, but even when assessed at regular intervals in ambulatory monitoring studies [2].”
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Mechanisms behind the success of exercise as an adjunct quit smoking aid
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“Individual cigarette withdrawal symptoms were assessed by Mood and Physical Symptoms Scale (MPSS) [38 - 40], which was developed in the early 1980s and variants of it have been used for 20 years.”
MethodCraving and treatment in smoking
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BackgroundNicotine Withdrawal and Depression
Gilbert, D. G., & Pergadia, M. L. (2016) · Elsevier eBooks · doi:10.1016/b978-0-12-802574-1.00017-x · Cited by 2
Self-citationZhang, M., Li, Q., Li, S., Sun, B., Wu, Z., Liu, J., Geng, X., & Chen, F. (2025) · Toxics · doi:10.3390/toxics13070586 · Cited by 1
“However, single measures fall short of capturing the full spectrum of withdrawal symptoms, often leading to biased assessments [36].”
Moss-Alonso, E., Rodríguez‐Cano, R., Martínez-Vispo, C., López‐Durán, A., & Becoña, E. (2025) · Addictive Behaviors · doi:10.1016/j.addbeh.2025.108439 · Cited by 1
Associations of nicotine concentration levels in e-cigarettes and tobacco dependence among US adults
Dai, H. D., Guastello, P. R., & Mahabee‐Gittens, E. M. (2026) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntag075 · Cited by 1
Predicting Binary Outcomes Using Trajectory Classes
Maruyama, N., Takahashi, F., Uno, H., & Takeuchi, M. (2012) · Statistics in Biopharmaceutical Research · doi:10.1080/19466315.2011.646912 · Cited by 1
“Methods by Matsumoto can be applied to changing patterns of craving in the case of the smoking cessation trial (Sayette et al. 2000; Shiffman, West, and Gilbert 2004).”
MethodProspective Evaluation of Factors Predicting Nicotine Withdrawal Symptoms Among Korean Americans
Kim, S. S., Fang, H., McKee, S. A., & Ziedonis, D. M. (2014) · The Journal of Smoking Cessation · doi:10.1017/jsc.2014.20 · Cited by 1
How Addictive Can Cigarettes Be? Two Case Reports
West, O., McRobbie, H. J., & Hájek, P. (2010) · The Journal of Smoking Cessation · doi:10.1375/jsc.5.1.102 · Cited by 1
Pouly, S., Haziza, C., Peck, M. J., & Peitsch, M. C. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-820490-0.00020-1 · Cited by 1
Nicotine Dependence and Cardiovascular Diseases: Biobehavioral and Psychosocial Correlates
Al’Absi, M., Nakajima, M., Green, P. A., Petersen, K. L., & Wittmers, L. E. (2022) · Springer eBooks · doi:10.1007/978-0-387-85960-6_12 · Cited by 1
Approaches to Smoking Cessation in a Cardiovascular Population
Sohn, M., Shishani, K., Okada, A., & Froelicher, E. S. (2012) · Springer eBooks · doi:10.1007/978-1-4419-5650-7_15 · Cited by 1
Sex Differences in Tobacco Abstinence: Effects on Executive Functioning
Eleuteri, F., Rusich, D., Jansari, A. S., & Arduino, L. S. (2019) · Psychology · doi:10.4236/psych.2019.1012107 · Cited by 1
“Abstinence-related signs and symptoms include depression, anxiety, irritable mood, disturbed appetite and reduced cognitive functioning (Shiffman, West, & Gilbert, 2004).”
Metadata
- 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 › Public Health, Environmental and Occupational Health › 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
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