How generalisable to community samples are clinical trial results for treatment of nicotine dependence: a comparison of common eligibility criteria with respondents of a large representative general population survey

Le Strat, Yann; Rehm, Jürgen; Le Foll, Bernard

doi:10.1136/tc.2010.038703

Cited by 67Smoking Behavior and CessationSubstance Abuse Treatment and OutcomesEthics in Clinical Research

How generalisable to community samples are clinical trial results for treatment of nicotine dependence: a comparison of common eligibility criteria with respondents of a large representative general population survey

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Le Strat, Yann, Rehm, Jürgen, Le Foll, Bernard·2011·Tobacco Control

DOI 10.1136/tc.2010.038703

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Abstract

Objective: To examine the generalisability of findings from clinical trials of individuals with nicotine dependence to a large general population sample. Methods: Eligibility criteria were drawn from typical criteria of clinical trials for nicotine dependence. The National Epidemiological Survey on Alcohol and Related Conditions (NESARC), a large national sample of the US population, was used to assess how many potentially eligible people would fulfil the eligibility criteria. NESARC interviewed more than 43 000 adults aged 18 years and older. We applied a standard set of eligibility criteria representative of smoking cessation clinical trials to all the 4962 adults with nicotine dependence in the past 12 months, and then to a subgroup of participants motivated to quit (n=4121). Results: We found that approximately six out of 10 participants (65.89%) with nicotine dependence were excluded by at least one criterion. In the subgroup of nicotine-dependent participants motivated to quit, more than half (58.60%) were excluded by at least one criterion. For the overall sample, smoking 10 cigarettes per day or less and lack of motivation to quit were the two criteria leading to exclusion for the greatest percentage of individuals (32.02% and 17.60%, respectively). For the sample motivated to quit, smoking 10 cigarettes or fewer per day and current depression led most frequently to exclusion (33.79% and 15.71%, respectively). Conclusions: Further studies and interventions should explore the efficacy of tobacco treatment interventions in a larger segment of the population, notably in the subpopulations of people with nicotine dependence who smoke fewer than 10 cigarettes per day or who have comorbid depression.

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Authors: Le Strat, Y., Rehm, J., & Le Foll, B.
Affiliations: Centre for Addiction and Mental Health (CA)
ORCID: Rehm, Jürgen
Venue: Tobacco Control
Publisher: BMJ
Published: 2011-01-06
Volume: 20
Issue: 5
Pages: 338-343
ISSN: 0964-4563 (ISSN-L)
1468-3318
DOI: 10.1136/tc.2010.038703
OpenAlex: W2154364515
Cited by: 67
References: 113
Citations by year: 2026: 1 · 2024: 1 · 2023: 3 · 2022: 1 · 2021: 4 · 2020: 4 · 2019: 3 · 2017: 7 · 2016: 9 · 2015: 10 · 2014: 4 · 2013: 11 · 2012: 7
FWCI: 5.23
Type: journal article
Language: en
Open access: green
hal.science
Licence: other-oa
Locations: Tobacco Control (publishedVersion)
PubMed (publishedVersion)
HAL (submittedVersion, other-oa)
Trinity's Access to Research Output (TARA) (Trinity College Dublin) (submittedVersion)
Funders: National Institutes of Health
Topics: Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Keywords: nicotine dependence, smoking cessation, inclusion and exclusion criteria, generalizability, motivation to quit, depression, NESARC
MeSH terms: Adolescent, Adult, Aged, Female, Health Surveys, Humans, Male, Middle Aged, Motivation, Tobacco Use Disorder, United States, Randomized Controlled Trials as Topic, Smoking Cessation, Treatment Outcome, Diagnosis, Dual (Psychiatry), Patient Selection, Diagnostic and Statistical Manual of Mental Disorders, Young Adult

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How generalisable to community samples are clinical trial results for treatment of nicotine dependence: a comparison of common eligibility criteria with respondents of a large representative general population survey

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