The Appeal and Impact of E-cigarettes in Smokers With SMI
Completed · Not applicable
Conditions studied: Tobacco Dependence, Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
In brief
This study will evaluate behavioral and psychological appeal, toxicity, and effect of e-cigarettes on smoking behavior and nicotine addiction in chronic smokers with serious mental illness (SMI) who have failed to quit smoking. A total of 240 participants will be enrolled and randomly assigned to either receive a supply of e-cigarettes for 8 weeks plus assessments (baseline \& weeks 2, 4, 6, 8, 13, \& 26) or assessments only. This single-blinded study will provide e-cigarettes and instructions on their safe use. Level of appeal will be inferred from carefully assessed use of e-cigarettes and reduction in combustible tobacco. Qualitative data will also be collected from participants assigned to e-cigarettes, given that unanticipated issues will almost certainly arise in connection with e-cigarette use that can only be captured within a qualitative debriefing at the conclusion of participants' time in the study.
Key facts
- Study ID
- NCT03050853
- Run by
- Dartmouth-Hitchcock Medical Center
- People needed
- 240
- Starts
- 2017-03-01
- Expected to finish
- 2021-01-31
- Last updated by the study team
- 2021-03-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
- Enrolled in services at the research site for a minimum of 3 months
- Regular smoker (approximately 10 cigarettes for the past 5 years) with a history of at least 1 quit attempt
- Fluent in English
You may not qualify if…
- Regular use of e-cigarettes in the past month
- Current interest/plan to quit smoking
- Regular use of nicotine replacement therapy to quit smoking or use of bupropion or varenicline to quit smoking
- Use of emergency room or hospitalization for psychiatric reasons in the past 30 days
Where it is running
- Centerstone Kentucky — Louisville, Kentucky, United States
- Vinfen Corp — Lawrence, Massachusetts, United States
Full record on ClinicalTrials.gov
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