E-cigarettes versus nicotine patches and lozenges to help people in substance-use treatment quit smoking

Evaluating a Tobacco Harm Reduction Strategy Among Clients Enrolled in Substance Use Disorder Treatment

This trial will test whether switching completely to e-cigarettes helps adults in outpatient substance use treatment quit smoking compared with using nicotine patches and lozenges.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Medical University of South Carolina (Academic / other)
• Locations: 4 sites (Charleston, South Carolina and 3 other locations)
• Trial ID: NCT06922617 on ClinicalTrials.gov

What this trial studies

This randomized interventional trial compares switching completely to e-cigarettes (nicotine vapes) with standard nicotine replacement therapy (patches and lozenges) among adults enrolled in outpatient substance use disorder (SUD) treatment. Participation lasts six months and includes five in-person visits, eleven virtual assessments, and a short daily smartphone diary for the first 12 weeks. Eligible participants are adults 21+ who smoke at least five cigarettes per day, are within 30 days of SUD treatment admission, and have biochemical confirmation of smoking; key exclusions include pregnancy, current frequent ENDS use, contraindications to NRT, or unstable medical/psychiatric conditions. The trial is conducted at several outpatient SUD programs affiliated with the Medical University of South Carolina across South Carolina.

Who should consider this trial

Good fit: Adults aged 21 or older who smoke at least five cigarettes per day, are within 30 days of starting outpatient SUD treatment, have positive breath CO and cotinine tests, and want to reduce or quit smoking are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, currently use e-cigarettes on most days (20+ days/month), have contraindications to NRT, or have unstable medical or psychiatric conditions may not benefit or be eligible.

Why it matters

Potential benefit: If successful, switching to e-cigarettes could offer a more acceptable and effective way for people in SUD treatment to stop smoking and reduce tobacco-related illness.

How similar studies have performed: E-cigarettes have shown promise versus NRT in some general-population trials, but rigorous randomized data specifically in people receiving SUD treatment are limited.

Eligibility criteria

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 pharmacotherapy with smoking cessation efficacy,
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.

Where this trial is running

Charleston, South Carolina and 3 other locations

• MUSC Charleston, Center for Drug and Alcohol Problems — Charleston, South Carolina, United States (Recruiting)
• Shoreline Behavioral Health Services — Conway, South Carolina, United States (Recruiting)
• Phoenix Center — Greenville, South Carolina, United States (Recruiting)
• Behavioral Health Services of Pickens County — Pickens, South Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Ela Williams

Conditions Tobacco Use; Substance Use Disorders