Harm Reduction for Smokers With Mental Illness

Not Applicable

Recruiting

• Conditions: Tobacco Dependence
• Interventions: Other: E-cig Provision Only; Behavioral: SWITCH IT

• Registration Number: NCT06543407
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2027-12-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E-cigarette provision only	E-cig Provision Only	Participants randomized to this condition will receive a supply of NJOY Daily e-cigarettes for the first 8 weeks of the study.
SWITCH IT	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.

Primary Outcome Measures

Name	Time	Method
Change in self-reported cigarette use	baseline to 8 weeks 8 weeks to 16 weeks	self-report of combustible cigarette use
Change in Urine NNAL	baseline to 8 weeks, 8 weeks to 26 weeeks	urine levels of NNAL
Change in CO level	baseline to 8 weeks, 8 weeks to 26 weeks	carbon monixide level less than 6

Trial Locations

Locations (2)

Seven Counties Services; 🇺🇸 Louisville, Kentucky, United States

Homer Stryker MD School of Medicine (WMed); 🇺🇸 Kalamazoo, Michigan, United States