The Effect of Electronic Cigarette Use on Smoking Behaviors Among Smokers Receiving Outpatient Psychiatric Treatment
Status unconfirmed · Not applicable
Conditions studied: Tobacco Smoking, Psychiatric Disorders
In brief
This study aims to establish the feasibility and acceptability of a project designed to investigate the impact of electronic cigarette use on combustible cigarette smoking and smoking-related factors among smokers with psychiatric disorders, a high-risk population, who are not yet ready to quit smoking. All participants will be instructed to switch completely from combustible cigarettes to e-cigarettes for the next 8 weeks. They will be assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
Key facts
- Study ID
- NCT04014322
- Run by
- Fordham University
- People needed
- 50
- Starts
- 2020-12-12
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2023-09-18
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 21 years of age or older
- English-speaking,
- current daily smokers (i.e., at least 5 cigarettes/day)
- have been daily smokers at least for 6 months
- attended a minimum of 2 treatment visits in the past 12 months at Montefiore Behavioral Health Center
- have at least one psychiatric disorder (other than substance use disorders),
- willing to try switching to use e-cigarettes (provided by the research team) exclusively for a total of 8 weeks,
- those who are not yet ready to quit smoking,
- for women of childbearing age, willingness to use contraception during the study.
You may not qualify if…
- acute psychiatric symptomatology which precludes study participation including current active suicidal ideation
- current diagnosis of dementia or cognitive impairment sufficient to impair provision of informed consent or study participation
- patient's inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures as contained in the statement of informed consent, after no more than two explanations
- current clinical diagnosis of intellectual development disorder
- current regular use of other tobacco products or combustible marijuana
- current (non-nicotine) substance use disorder and current substance use (in the past month)
- current effort to quit smoking or current use of pharmacotherapy (in the past month) to quit smoking,
- pregnant, breastfeeding, or planning to become pregnant within 6 months, current unstable cardiovascular disease,
- current unstable pulmonary disease (i.e., an ER visit or hospitalization due to pulmonary issues in the past 6 month or current use of oxygen therapy),
- patient does not have a stable home address where the research team could reliably reach patient
- household members are currently participating or have participated in this research study
Where it is running
- Montefiore Behavioral Health Center — The Bronx, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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