Recruiting

E-Cigarettes vs. Nicotine Replacement Therapy

Sponsor:

Medical University of South Carolina

Code:

NCT06922617

Conditions

Tobacco Use

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Switching to E-Cigarette

Quitting using Medication

Counseling

Study Details

Brief summary:

The purpose of this study is to investigate whether non-cigarette tobacco products, namely e-cigarettes (nicotine vapes), can help people who smoke and are in treatment for substance use disorder quit smoking by switching completely to e-cigarettes as compared to FDA-approved medications, namely nicotine replacement therapy in the form of patches and lozenges. Participation will last 6 months and includes 14 weekly study visits and 2 follow-up study visits (in-person, but virtual study visits are possible). Participants will also complete a short daily diary on their phones each day for the first twelve weeks. To qualify, participants (ages 21+) must be enrolled in an outpatient substance use disorder (SUD) treatment program. The study is being done in four regions across South Carolina: Charleston, Pickens/Easley, Conway, and Greenville.

Conditions

Tobacco Use

Substance Use Disorders

Study ID

NCT06922617

Start date

Oct 17, 2025

Status verified date

Sep, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 21+ years of age,
2. smoke at least 5 cigarettes per day daily or near daily for the past 6 months,
3. be enrolled in outpatient SUD treatment and have an SUD diagnosis (past or current),
4. must submit a breath CO sample of ≥ 7 parts per million at screening and a positive instant-read urinary cotinine test,
5. have had at least one failed smoking quit attempt in their lifetime,
6. have interest in reducing smoking, quitting smoking, or switching to a less harmful product, and
7. if female, agrees to use a form of birth control during the study.

Exclusion criteria:

1. any significant or unstable medical or psychiatric concern that would affect safety,
2. current use of smoking cessation pharmacotherapy for the purposes of quitting smoking,
3. pregnant, breastfeeding, or trying to become pregnant,
4. contraindicated for NRT, and
5. currently using an ENDS on 20+ days out of the past 30.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Medication

This arm includes participants randomly assigned to the medication group. Participants will receive combination nicotine replacement therapy (NRT). The NRT will consist of transdermal patches and nicotine lozenges. Participants will receive study product for 12 weeks.

experimental: Switching to an E-Cigarette

This arm includes participants randomly assigned to the E-Cigarette Group. Participants will receive a study-provided e-cigarette product for 12 weeks.

Interventions

Switching to E-Cigarette

Participants will receive twelve weeks of e-cigarette products with instructions to switch completely at switch date

Quitting using Medication

Participants will receive twelve weeks of FDA approved medication, combination NRT, with instructions to quit smoking cigarettes at quit date

Counseling

Participants will recieve brief weekly counseling to support their quit or switch attempt from cigarettes.

Primary outcome measure

  • Abstinence from smoking at end of treatment [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Ela Williams

(843) 876-2090williela@musc.edu

Locations

MUSC Charleston

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Ela Williams

843-876-2090williela@musc.edu

Shoreline Behavioral Health Services

Recruiting

Conway, South Carolina, United States, 29526

Contacts

April Lehman

843-698-2767alehman@shorelinebhs.org

Phoenix Center

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Daniel Moss

864-898-2992mossd@musc.edu

Behavioral Health Services of Pickens County

Recruiting

Pickens, South Carolina, United States, 29671

Contacts

Elizabeth Chapman, LPC

864-898-2992chapmanb@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-09-03.