Harm Reduction for Smokers With Mental Illness

Dartmouth Health

Status: Enrolling

Conditions: Tobacco Dependence

Treatments: Other: E-cig Provision Only; Behavioral: SWITCH IT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06543407

R01DA057729-01A1 (U.S. NIH Grant/Contract)

02002328

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

E-cigarette provision only

Active Comparator group

Description:

Participants randomized to this condition will receive a supply of NJOY Daily e-cigarettes for the first 8 weeks of the study.

Treatment:

Other: E-cig Provision Only

SWITCH IT

Experimental group

Description:

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.

Treatment:

Behavioral: SWITCH IT