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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06543407

Enrollment

250

Registered

2024-08-09

Start date

2024-10-01

Completion date

2028-03-31

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Dependence

Keywords

serious mental illness, harm reduction, e-cigarettes

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

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Outcomes assessor blind

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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
Change in self-reported cigarette use	baseline to 8 weeks 8 weeks to 16 weeks	self-report of combustible cigarette use

Countries

United States

Contacts

Primary ContactMeghan M. Santos, MSW

meghan.m.santos@hitchcock.org978-494-4260

Backup ContactGail Williams, MS, MFT

gail.williams@dartmouth.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026