Harm Reduction for Smokers with Mental Illness Study

This study is looking at ways to help people with mental illnesses who smoke reduce the harm from cigarettes, especially if they aren't ready to quit completely. It compares providing e-cigarettes (NJOY) alone with providing e-cigarettes along with behavioral support called SWITCH IT. SWITCH IT involves coaching sessions and opportunities to explore e-cigarette options. The study aims to see if these approaches can reduce how much you smoke and how much nicotine your body takes in. You might be able to join if you are 21 or older, speak English, smoke at least 10 cigarettes a day, and have a diagnosis like schizophrenia, bipolar disorder, major depressive disorder, or anxiety disorders. The study is currently unclear about its recruitment status and plans to enroll 250 participants.

Study design
This interventional study plans to enroll 250 participants. It compares two groups: one receiving e-cigarettes only, and another receiving e-cigarettes with behavioral support.
What's involved
Participants will receive e-cigarettes for the first 8 weeks. Those in the SWITCH IT group will also have 7-10 behavioral support sessions over the first 8 weeks, with optional field trips in week 4.
Compensation
Not stated in the trial record.
Follow-up
Your urine NNAL and CO levels will be measured at 8 weeks and 26 weeks. Self-reported cigarette use will be measured at 8 weeks and 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06543407

Harm Reduction for Smokers With Mental Illness

Recruiting
NAAges 21+InterventionalTreatment
Dartmouth-Hitchcock Medical Center
~250 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:SWITCH ITE-cig Provision Only

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Urine NNAL
Measured over baseline to 8 weeks, 8 weeks to 26 weeeks
+2 more outcomes measured
Tobacco Dependence
2 sites across 2 states
Kentucky1
Rhode Island1
  • Sarah I. Pratt, PhD · PRINCIPAL_INVESTIGATOR · Dartmouth Health

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.
  • Change in Urine NNALbaseline to 8 weeks, 8 weeks to 26 weeeks

    urine levels of NNAL

  • Change in CO levelbaseline to 8 weeks, 8 weeks to 26 weeks

    carbon monixide level less than 6

  • Change in self-reported cigarette usebaseline to 8 weeks 8 weeks to 16 weeks

    self-report of combustible cigarette use