Using e-cigarettes to help smokers with serious mental illness reduce smoking
Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness
This study is testing if e-cigarettes can help people with serious mental illness cut down on smoking compared to traditional nicotine replacement therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05815199 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized controlled trial aims to evaluate the effectiveness of e-cigarettes compared to nicotine replacement therapy in reducing combustible cigarette smoking among individuals diagnosed with serious mental illness. Participants will receive harm-reduction counseling and Ecological Momentary Intervention text messaging to support their smoking reduction efforts. The study will involve individuals who smoke at least five cigarettes per day and are interested in reducing their smoking without necessarily quitting completely. The trial will assess the impact of these interventions on smoking behavior over a specified period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 and older who smoke at least five combustible cigarettes per day and have a diagnosis of serious mental illness.
Not a fit: Patients who are currently attempting to quit smoking or have used other forms of tobacco in the past two weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a viable harm reduction strategy for smokers with serious mental illness, potentially leading to improved health outcomes.
How similar studies have performed: Other studies have explored harm reduction strategies for smoking, but the specific use of e-cigarettes in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Currently smokes 5 or more CPD * Willingness and ability to provide informed consent * Age of at least 21 years * Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool * Interested in reducing CC smoking but not necessarily trying to quit * Own a mobile phone or have regular access to a mobile phone * Able to provide an additional contact to improve follow-up rates Exclusion Criteria: * Is pregnant or breastfeeding * Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo) * Currently engaged in an attempt to quit CC * Change in dose of their psychotropic medication(s) in the last 30 days * Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders. * Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Omar El-Shahawy — NYU Langone Health
- Study coordinator: Omar El-Shahawy
- Email: Omar.ElShahawy@nyulangone.org
- Phone: 646-501-3587
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.