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

NCT ID: NCT07202039

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2030-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sweet-Cooling EC + Counseling

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.

Group Type EXPERIMENTAL

Brief individual counseling sessions

Intervention Type 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

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.

Group Type EXPERIMENTAL

Brief individual counseling sessions

Intervention Type BEHAVIORAL

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

Tobacco-flavored EC + Counseling

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.

Group Type ACTIVE_COMPARATOR

Brief individual counseling sessions

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief individual counseling sessions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Prisma Health-Upstate

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Irene Pericot-Valverde

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Addiction Medicine Center

Greenville, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Irene Pericot-Valverde, PhD

Role: CONTACT

(864)656-4467

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alain Litwin, MD

Role: primary

(864) 455-5648

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K01DA062708

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2328661-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Buprenorphine Dose Alteration Study - 1
NCT00000219 COMPLETED PHASE1
Opioids and Smoking Cessation
NCT03857139 WITHDRAWN PHASE4
Novel Induction to Buprenorphine/Naloxone
NCT05644587 TERMINATED PHASE4