Electronic Cigarettes in Smokers With Mental Illness
Condition: Schizophrenia; Schizophreniform Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      People with mental illness are more likely to smoke and are more severely addicted to
      nicotine than the general population. As a result, the number of deaths related to tobacco is
      higher.

      Smoking is highly addictive because it delivers nicotine very quickly. Research studies show
      that people who use nicotine replacement therapies (such us patches, gums, etc) are more
      likely to quit smoking than those who try to quit without using these nicotine products.
      Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette
      (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic
      traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals
      contained in tobacco cigarettes.

      Given the increasing popularity of e-cigs, there is an urgent need to improve our
      understanding of both the potential benefits and risks of e-cigs use in people with serious
      mental illness. In this pilot we propose inviting 50 people with schizophrenia (or
      schizophrenia-related disorder) who are not intending to quit smoking in the near future to
      take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week
      period in which they will not receive free e-cigs and we monitor which products participants
      choose, and a final 24-week follow-up visit. During the 24-week study period we will assess
      the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants,
      nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as
      well as the e-cigs perceived benefits and risks.
    


Intervention name(s): disposable electronic cigarettes
Intervention type(s): Other
Intervention description(s): Participants will receive e-cigs free of charge during 6-week. Each week for 6 weeks, participants will receive enough e-cigs to cover 150% of their usual weekly cigarette smoking rate. We will encourage participants to use the e-cigs whenever they would usually smoke a cigarette.
During a 4-week post-distribution period, we will assess e-cig and cigarette use and other measures when e-cigs are not being freely provided and participants must purchase them on their own. The Week 10 session at the end of this period includes assessment of total nicotine intake, nicotine dependence, subjective and reinforcing effects of e-cigs and cigarettes, attitudes toward e-cigs, motivation to quit and self-efficacy for smoking cessation. At the Week 24 follow-up session we will again collect these measures to determine if any changes observed during the intervention phases have been maintained.
Other intervention name(s): NJOY
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: electronic cigarettes; smoking; schizophrenia; serious mental illness