Investigating how e-cigarettes affect smoking habits in psychiatric patients
The Effect of Electronic Cigarette Use on Smoking Behaviors and Smoking-related Factors Among Smokers Receiving Outpatient Psychiatric Treatment
NA · Fordham University · NCT04014322
This study is testing if switching to e-cigarettes can help people with psychiatric disorders who smoke reduce their traditional cigarette use over 8 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Fordham University (other) |
| Locations | 1 site (Bronx, New York) |
| Trial ID | NCT04014322 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the feasibility and acceptability of using electronic cigarettes to reduce combustible cigarette smoking among individuals with psychiatric disorders who are not ready to quit smoking. Participants will switch from traditional cigarettes to e-cigarettes for 8 weeks, with assessments conducted at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks to evaluate changes in smoking behavior and readiness to quit. The study will involve 50 adult daily smokers receiving outpatient psychiatric treatment, and e-cigarettes will be provided at no cost. The research seeks to fill the gap in understanding the impact of e-cigarette use on smoking behaviors in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who are daily smokers with at least one psychiatric disorder and are not ready to quit smoking.
Not a fit: Patients with acute psychiatric symptoms or cognitive impairments that prevent informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an alternative smoking cessation method for individuals with psychiatric disorders.
How similar studies have performed: While the use of e-cigarettes among smokers has been studied, this specific approach targeting psychiatric patients is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Bronx, New York
- Montefiore Behavioral Health Center — Bronx, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Haruka Minami, Ph.D. — Fordham University
- Study coordinator: Haruka Minami, Ph.D.
- Email: hminami@fordham.edu
- Phone: (718) 817-3885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tobacco Smoking, Psychiatric Disorders, electronic cigarette use, smoking behavior