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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
  1. Yann Le Strat1,2,3,4,5,
  2. Jürgen Rehm6,7,8,
  3. Bernard Le Foll1,2
  1. 1Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, Toronto, Ontario, Canada
  2. 2Addiction Program, Centre for Addiction and Mental Health, Toronto, Ontario, Canada
  3. 3INSERM U894, Team 1, Centre for Psychiatry and Neurosciences, Paris, France
  4. 4Department of Psychiatry, Louis-Mourier Hospital, AP-HP, Colombes, France
  5. 5Faculty of Medicine, University Paris 7 Denis-Diderot, Paris, France
  6. 6Centre for Addiction and Mental Health (CAMH), Toronto, Canada
  7. 7Dalla Lana School of Public Health (DLSPH), University of Toronto, Canada
  8. 8Institute for Clinical Psychology and Psychotherapy, TU Dresden, Germany
  1. Correspondence to Dr Yann Le Strat, INSERM and Centre for Addiction and Mental Health, 2 ter rue d'Alèsia, Paris, 75014, France; yann.lestrat{at}inserm.fr

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.

  • Addiction

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Footnotes

  • Funding The National Epidemiologic Survey on Alcohol and Related Conditions was sponsored by the National Institute on Alcohol Abuse and Alcoholism and funded, in part, by the Intramural Program of DHHS-NIH-NIAAA. YLS is funded by a grant from the Société Française de Tabacologie and the Addiction Program of CAMH.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the US Census Bureau and the Office of Management and Budget.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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