ClinicalTrials.gg
RecruitingNCT06543407Updated Jan 15, 2026

Harm Reduction for Smokers With Mental Illness

An interventional study of SWITCH IT and E-cig Provision Only in Tobacco Dependence, sponsored by Dartmouth-Hitchcock Medical Center. Recruiting at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT

02

Conditions studied

  • Tobacco Dependence

Keywords

  • serious mental illness
  • harm reduction
  • e-cigarettes
03

In context

Tobacco Use Disorder

1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.

This study's planned enrollment of 250 is above the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
250 participants (estimated)

Study arms

  • Active comparator
    E-cigarette provision only

    Participants randomized to this condition will receive a supply of NJOY Daily e-cigarettes for the first 8 weeks of the study.

    Other: E-cig Provision Only

  • Experimental
    SWITCH IT

    Participants randomized to this condition will receive a supply of e-cigarettes and behavioral support and coaching, protocolized intervention, SWITCH IT, for the first 8 weeks of the study.

    Behavioral: SWITCH IT

Interventions

  • BehavioralSWITCH IT

    Behavioral support for switching, 7-10 sessions with SWITCH IT coach delivered during the first 8 weeks of the study. SWITCH IT participants will also have the opportunity to receive supported "field trips" to explore e-cigarette options based on availability, cost, and preferences during week 4 and week 6.

  • OtherE-cig Provision Only

    Provision of e-cigarettes (NJOY) based on combusible use for the first 8 weeks of the study.

06

What researchers measure

Primary outcomes

  1. Change in Urine NNAL

    urine levels of NNAL

    Time frame: baseline to 8 weeks, 8 weeks to 26 weeeks

  2. Change in CO level

    carbon monixide level less than 6

    Time frame: baseline to 8 weeks, 8 weeks to 26 weeks

  3. Change in self-reported cigarette use

    self-report of combustible cigarette use

    Time frame: baseline to 8 weeks 8 weeks to 16 weeks

07

Study locations

2 of 2 sites recruiting
  • Seven Counties Services
    Louisville, Kentucky 40203, United States
    Recruiting
  • The Providence Center
    Providence, Rhode Island 02903, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06543407
Collaborators
Dartmouth College, Fordham University, Seven Counties Services, Western Michigan University School of Medicine, National Institute on Drug Abuse (NIDA)
Responsible party
Sarah Pratt (Associate Professor, Dartmouth-Hitchcock Medical Center) — Principal investigator
First posted
Aug 9, 2024
Start date
Oct 1, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Jan 15, 2026

Study contacts

Meghan M. Santos, MSW
Contact
meghan.m.santos@hitchcock.org
978-494-4260
Gail Williams, MS, MFT
Contact
gail.williams@dartmouth.edu
Sarah I. Pratt, PhD
principal investigator · Dartmouth Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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