Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine (SWITCH)

Prisma Health-Upstate

Status: Not yet enrolling

Conditions: Sweet Non-cooling EC; Tobacco-flavored EC; Sweet-Cooling EC

Treatments: Behavioral: Brief individual counseling sessions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07202039

2328661-1

K01DA062708 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This project aims to investigate the impact of e-cigarette flavors and usage patterns on achieving harm-reduction milestones in a sample of cigarette smokers with opioid use disorder who are taking buprenorphine

Enrollment: 90 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age ≥21 years
• Smoke ≥5 CPD for ≥1 year
• Daily CC smoker
• Willing to switch to EC
• Exhaled CO ≥6 ppm
• Diagnosed with OUD
• Stable on bupropion treatment
• In good physical and mental health
• Able to use a smartphone
• Willing to participate in all study components
• Able to provide informed consent Exclusion Criteria
• Interested in quitting CC (contemplation stage of change)
• Use of EC on ≥4 of the past 30 days
• Use of other tobacco products (e.g., cigars, smokeless tobacco) on ≥9 days of the past 30 days
• Use of nicotine replacement therapy, smoking cessation medication, or a cessation attempt in the past 30 days
• Hypertension
• Medical condition that would contraindicate participation
• Meet DSM-V criteria for major depressive episode, psychotic episode, or manic episode
• Current suicidal ideation or suicide attempt in the past year
• Psychiatric hospitalization in the past year
• Contemplating pregnancy, currently pregnant, or breastfeeding
• Unable to speak and/or read English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Sweet-Cooling EC + Counseling

Experimental group

Description:

Those randomized to the intervention group will be provided a free 12-week supply of sweet-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.

Treatment:

Behavioral: Brief individual counseling sessions

Sweet non-cooling EC + Counseling

Experimental group

Description:

Those randomized to the intervention group will be provided a free 12-week supply of sweet non-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.

Treatment:

Behavioral: Brief individual counseling sessions

Tobacco-flavored EC + Counseling

Active Comparator group

Description:

Those randomized to the intervention group will be provided a free 12-week supply of tobacco-flavored electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.

Treatment:

Behavioral: Brief individual counseling sessions