Recruiting

Harm Reduction

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT06543407

Conditions

Tobacco Dependence

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

SWITCH IT

E-cig Provision Only

Study Details

Brief 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

Conditions

Tobacco Dependence

Study ID

NCT06543407

Start date

Oct 1, 2024

Status verified date

Nov, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

SWITCH 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.

E-cig Provision Only

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

Primary outcome measure

  • Change in Urine NNAL [ Time Frame: baseline to 8 weeks, 8 weeks to 26 weeeks ]
  • Change in CO level [ Time Frame: baseline to 8 weeks, 8 weeks to 26 weeks ]
  • Change in self-reported cigarette use [ Time Frame: baseline to 8 weeks 8 weeks to 16 weeks ]

Central Contacts and Locations

Central contacts

Meghan M. Santos, MSW

978-494-4260meghan.m.santos@hitchcock.org

Gail Williams, MS, MFT

gail.williams@dartmouth.edu

Locations

Seven Counties Services

Recruiting

Louisville, Kentucky, United States, 40203

Contacts

Cheri Green, EdD, MSN, RN

cheri.green@sevencounties.org

Dylan Hillerich, MEd

dylan.hillerich@sevencounties.org

The Providence Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Diane Beckman, PhD

4012764020dbeckman@careNE.org

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Jan 15, 2026

Last verified

Nov, 2025

Keywords

  • serious mental illness
  • harm reduction
  • e-cigarettes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-01-15.