Harm Reduction for Smokers With Mental Illness

Harm Reduction for Smokers With Mental Illness: RCT of E-cigarette Provision With or Without Behavioral Support to Boost Switching

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

Study Overview

• Status: Recruiting
• Conditions: Tobacco Dependence
• Intervention / Treatment: Other: E-cig Provision Only; Behavioral: SWITCH IT

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghan M. Santos, MSW; Phone Number: 978-494-4260; Email: meghan.m.santos@hitchcock.org
• Study Contact Backup: Name: Gail Williams, MS, MFT; Email: gail.williams@dartmouth.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40203
      • Recruiting
      • Seven Counties Services
      • Contact: Cheri Green, EdD, MSN, RN; Email: cheri.green@sevencounties.org
      • Contact: Dylan Hillerich, MEd; Email: dylan.hillerich@sevencounties.org
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • The Providence Center
      • Contact: Diane Beckman, PhD; Phone Number: 4012764020; Email: dbeckman@careNE.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Provision of e-cigarettes (NJOY) based on combusible use 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); Dartmouth College; Fordham University; Western Michigan University School of Medicine; Seven Counties Services
• Investigators: Principal Investigator: Sarah I. Pratt, PhD, Dartmouth Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: harm reduction; e-cigarettes; serious mental illness
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Smoking; Tobacco Use Disorder; Vaping; Harm Reduction
• Other Study ID Numbers: 02002328; R01DA057729-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No