How generalizable 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

International audienceAbstract Objectives: To examine the generalizability 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 United States 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 4,962 adults with past 12 months nicotine dependence, and then to a sub-group of participants motivated to quit (n=4,121). Results: We found that approximately 6 out of ten participants (65.89%) with nicotine dependence were excluded by at least one criterion. In the sub-group of nicotine dependent participant 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 less than 10 cigarettes per day or less and current depression led most frequently to exclusion (33.79% and 15.71% respectively). Conclusions: Further studies and interventions should explore efficacy of tobacco treatment interventions in larger segment of the population, notably on the subpopulations of people with nicotine dependence who smoke less than 10 cigarettes per day or with comorbid depression