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

NCT07202039 | Not Yet Recruiting DMC

• 2 other identifiers: 2328661-1K01DA062708
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Cigarette Smoking; Opioid use disorder; Burprenorphine; Electronic cigarettes; Switching; Flavors

Outcome Measures

Primary Outcomes (1)

• Change in cigarettes smoked per day

  The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to weeks 12

  Baseline to week 12

Secondary Outcomes (6)

• Change in cigarettes smoked per day

  Baseline to week 24

• Percentage of participants with a ≥50% reduction in CPD

  Baseline to weeks 12 and 26

• Switching

  Weeks 12 and 24

• Partial Switching

  Weeks 12 and 24

• 7-Day CC Abstinence

  Weeks 12 and 26

Study Arms (3)

Sweet-Cooling EC + Counseling

EXPERIMENTAL

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.

Behavioral: Brief individual counseling sessions

Sweet non-cooling EC + Counseling

EXPERIMENTAL

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.

Behavioral: Brief individual counseling sessions

Tobacco-flavored EC + Counseling

ACTIVE COMPARATOR

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.

Behavioral: Brief individual counseling sessions

Interventions

Brief individual counseling sessions BEHAVIORAL

Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC

Sweet non-cooling EC + Counseling; Sweet-Cooling EC + Counseling; Tobacco-flavored EC + Counseling

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Addiction Medicine Center

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Opioid-Related Disorders; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Irene Pericot-Valverde, PhD

CONTACT

(864)656-4467; iperico@clemson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start (Estimated): April 29, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): June 29, 2029
• Last Updated: April 16, 2026

Record last verified: 2025-09

Locations

US (1)