Reducing harm for smokers with mental illness using e-cigarettes
Harm Reduction for Smokers With Mental Illness: RCT of E-cigarette Provision With or Without Behavioral Support to Boost Switching
NA · Dartmouth-Hitchcock Medical Center · NCT06543407
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center (other) |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Trial ID | NCT06543407 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using e-cigarettes for harm reduction among smokers, but this specific approach with telehealth support is relatively novel.
Eligibility criteria
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 this trial is running
Louisville, Kentucky and 1 other locations
- 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
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 Dependence, serious mental illness, harm reduction, e-cigarettes