Reducing harm for smokers with mental illness using e-cigarettes
Official title: Harm Reduction for Smokers With Mental Illness: RCT of E-cigarette Provision With or Without Behavioral Support to Boost Switching
Run by Dartmouth-Hitchcock Medical Center · NCT06543407 · Data updated 2026-11-12
This study is testing whether giving e-cigarettes with or without online support can help daily smokers with serious mental illness manage stress and reduce harm, even if they aren't ready to quit smoking yet.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT06543407 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 21 and older with serious mental illnesses such as schizophrenia, bipolar disorder, or major depressive disorders who smoke at least 10 cigarettes a day.
✕Probably not a fit
Patients currently interested in quitting smoking or those with certain medical conditions, such as asthma or cognitive impairment, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the effectiveness of providing e-cigarettes with and without behavioral support through telehealth for smokers with serious mental illness who are not ready to quit smoking. It aims to reduce harm by examining how e-cigarettes can be used as a coping mechanism for stress and distress. Participants must be daily smokers with a history of quit attempts but currently uninterested in cessation. The study will assess self-regulation and self-efficacy as potential mechanisms for behavior change.
Why it matters
Potential benefit: If successful, this approach could provide a safer alternative for smokers with mental illness, reducing their tobacco-related harm.
How similar studies have gone: Other studies have shown promise in using e-cigarettes for harm reduction among smokers, but this specific approach with telehealth support is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Diagnostic Criteria (must have one to be eligible): * Schizophrenia * Bipolar disorder * Major Depressive Disorders * Posttraumatic disorder * Other anxiety disorders Additional Inclusion Criteria: * 21 years or older; * English-speaking; * Daily smoker (at least 10 cigarettes/day); * At least one quit attempt in the past 5 years using evidence- based pharmacotherapy or behavioral cessation support; * Not currently interested in quitting. Exclusion Criteria: * Currently residing in a nursing home; * Current diagnosis of Asthma; * Cognitive impairment (score \<26 on the Telephone Interview for Cognitive Status (TICS); * Current use of e-cigarettes (\>once a week); * Psychiatric instability (hospitalized in the past month); * Current AND moderate to severe substance use disorder; * Pregnant or planning to become pregnant; * Use of any smoked products other than cigarettes; * Current unstable medical illness making e-cigarette unsafe (e.g., recent heart attack, cancer); * Participation in SWITCH IT pilot study.
Where it's running
-
Seven Counties Services
Louisville, Kentucky, United States Recruiting -
The Providence Center
Providence, Rhode Island, United States Recruiting
Study contacts
- Principal investigator: Sarah I. Pratt, PhD — Dartmouth Health
- Study coordinator: Meghan M. Santos, MSW
- Email: meghan.m.santos@hitchcock.org
- Phone: 978-494-4260
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.