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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 201–255 of 255
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Jackson, S. E., Brown, J., West, R., Norris, E., Livingstone‐Banks, J., & Lindson, N. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013696 · Cited by 1
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Variation in bupropion findings is not due to differences in measurement: comment on Teneggi et al.
Shiffman, S. M. (2006) · Psychopharmacology · doi:10.1007/s00213-006-0315-5 · Cited by 1
“(See Sayette et al. 2000 and Shiffman et al. 2004 for discussion of analytic approaches.)”
BackgroundSelf-citationWang, S. (2010) · Library and Archives Canada (Government of Canada) · Cited by 1
THE BEHAVIORAL EFFECTS OF FIRST-GENERATION ELECTRONIC CIGARETTES AFTER 24-HOUR TOBACCO DEPRIVATION
Harvanko, A. M. (2015) · UKnowledge (University of Kentucky)
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“…of tobacco use determines a withdrawal syndrome, characterized by agitation, irritation, frustration or anger, concentration difficulty, depressed mood, anxiety, restlessness, decreased heart rate and increased appetite or weight gain (Benowitz, 2010; Perkins, 2002; Shiffman et al., 2004).”
BackgroundThe Early Time Course of Smoking Withdrawal Symptoms
Hendricks, P. S. (2006) · Digital Commons - University of South Florida (University of South Florida)
Early chronic airway disease in young and middle-aged smokers
Toljamo, T. (2012) · Työväentutkimus Vuosikirja
The Role of Aftereffects and Withdrawal in Addiction
Kassel, J. D., Veilleux, J. C., Heinz, A. J., Braun, A. R., & Weber, S. (2013) · Wiley eBooks · doi:10.1002/9781118384404.ch11
Tobacco smoking, high body mass index and the outcome after surgery : The role of intervention
Sadr‐Azodi, O. (2008) · Figshare
Dawning Dependence: Processes underlying smoking cessation in adolescence
Kleinjan, M. (2009) · EUR Research Repository (Erasmus University Rotterdam)
Individualized Smoking Cessation Treatment: Roles For Sets Of Genomic Markers
Uhl, G. R., & Rose, J. E. (2011) · Personalized Medicine · doi:10.2217/pme.11.4
Pergadia, M. L., & Gilbert, D. G. (2012) · Addiction · doi:10.1111/j.1360-0443.2012.04071.x
“It is critical that such randomized controls be used in future internet and other studies characterizing withdrawal symptoms, because failure to do so fails to address the issue of decreasing negative affect and other withdrawal indices resulting from repeated testing, rather than from an actual diminution of symptoms…”
BackgroundSelf-citationBronars, C. A. (2011) · KU ScholarWorks (The University of Kansas)
Cigarette smoking: Attentional mediation of anxiety as a predictor of nicotine withdrawal severity
Morrell, H. E. R. (2007) · ThinkTech (Texas Tech University)
Muñoz, M. Á., Sanjuan, R., & Montoya, P. (2011)
Chronic pain and cigarette smoking: The elucidation of a synergistic relationship
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Broszkiewicz, M., & Drygas, W. (2016) · Medycyna Pracy · doi:10.13075/mp.5893.00327
Smoking Assessment through Information Technology
Gremigni, P. (2009) · IGI Global eBooks · doi:10.4018/978-1-60566-356-2.ch013
Taleb, Z. B. (2016) · FIU - Digital Commons (Florida International University) · doi:10.25148/etd.fidc000707
“First, withdrawal symptoms have a substantial role in inducing smoking relapse that compromises cessation outcomes (Shiffman et al., 2004).”
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Goesling, J. (2011)
Rios, L. E., Freire, M. D. C. M., & Costa, N. L. (2018) · Revista Odonto Ciência · doi:10.15448/1980-6523.2017.3.26317
“Description of treatment: The patient received a treatment for smoking cessation involving behavioural support and NRT – transdermal patches and nicotine chewing gum.”
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Cigarette Addiction in Flight Personnel and Coping Methods with Nicotine Deficiency During Flight
İlkhan, G. D. (2019) · BOĞAZİÇİ TIP DERGİSİ · doi:10.14744/bmj.2019.79553
김민혁, & 민성호 (2011) · Journal of Korean Medical Association
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Tønnesen, P., Карроззи, Л., Фагерстрем, К. О., Грациу, К., Хименезруиз, К., Nardini, S. G., Виеджи, Д., Лаццаро, К., Кэмпелл, И. А., Dagli, E. I., et al. (2010) · PULMONOLOGIYA · doi:10.18093/0869-0189-2010-2-9-36
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“It has been argued that nicotine withdrawal syndrome manifests in anxiety and depression-like behaviors [9].”
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Cohn, A. M., Cassidy, R. N., Denlinger-Apte, R. L., Donny, E. C., Villanti, A. C., Hatsukami, D. K., Dunn, D. S., Wyatt, R., Niznik, T., Cohen‐Davidyan, T., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2022-067694
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“Reducing craving is an important goal in the clinical and public health interventions of tobacco use (Do & Galván, 2014; Shiffman et al., 2004; Wang, Lowen, et al., 2015; Wang, Romer, et al., 2015).”
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Meta-Analysis Of Studies Investigation Of The Effect Of Smoking Cessation On Impatience
Dash, M. C. (2014) · ScholarWorks -A service of University of Vermont Libraries (University of Vermont)
Adkins-Hempel, M., Japuntich, S. J., Chrastek, M., DUNSIGER, S. I., Breault, C., Ayenew, W., Everson‐Rose, S. A., Nijjar, P. S., Bock, B. C., Wu, W.-C., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26589072
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Ramos-Rolón, A. P., Langleben, D. D., Lynch, K. G., Wiers, C. E., & Shi, Z. (2026) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2026.113066
Smoking cessation with CBT and mindfulness: study protocol for a randomized controlled trial
Chen, R., Ye, R., & Liao, Y. (2026) · Trials · doi:10.1186/s13063-026-09611-9
“The models will integrate longitudinal data for each secondary outcome at its specified time points (baseline, weeks 4, 8, 12, 16, 20, 26 for smoking frequency, craving intensity, and weight change; baseline, weeks 12, 26 for emotional regulation, sleep quality, and nicotine dependence) for overall…”
Dowd, A. N., Moody, K., Bagley, E. M., DeMass, R., Toll, B. A., Smith, T. T., & Palmer, A. M. (2026) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntag166
Palacio, M. V. (2026) · SSRN Electronic Journal · doi:10.2139/ssrn.7149598 · Cited by 1
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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