Harm Reduction for Smokers With Mental Illness

NCT06543407 | Recruiting DMC

• 2 other identifiers: 02002328R01DA057729-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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

Keywords

serious mental illness; harm reduction; e-cigarettes

Outcome Measures

Primary Outcomes (3)

• Change in Urine NNAL

  urine levels of NNAL

  baseline to 8 weeks, 8 weeks to 26 weeeks

• Change in CO level

  carbon monixide level less than 6

  baseline to 8 weeks, 8 weeks to 26 weeks

• Change in self-reported cigarette use

  self-report of combustible cigarette use

  baseline to 8 weeks 8 weeks to 16 weeks

Study Arms (2)

E-cigarette provision only

ACTIVE COMPARATOR

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

SWITCH IT

EXPERIMENTAL

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

SWITCH IT BEHAVIORAL

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.

SWITCH IT

E-cig Provision Only OTHER

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

E-cigarette provision only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator
• Fordham University: collaborator
• Seven Counties Services: collaborator
• Western Michigan University School of Medicine: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Seven Counties Services

Louisville, Kentucky, 40203, United States

RECRUITING

The Providence Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Harm Reduction; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Smoking

Study Officials

• Sarah I. Pratt, PhD

  Dartmouth Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan M. Santos, MSW

CONTACT

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

Gail Williams, MS, MFT

CONTACT

gail.williams@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 15, 2026

Record last verified: 2025-11

Locations

US (2)