Clinical trial Recruiting at 2 sites Interventional Ages 21 and up

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 typeInterventional
Ages21 Years and up
SexAll
Enrollment250 (estimated)
SponsorDartmouth-Hitchcock Medical Center
Academic / other
Locations2 sites (Louisville, Kentucky and 1 other locations)
StatusRecruiting
StartedOctober 1, 2024
Main results expectedDecember 31, 2027
Study endsMarch 31, 2028
Registry record updatedJanuary 15, 2026
Trial IDNCT06543407 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.