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RECRUITING Not applicable ClinicalTrials.gov

STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking

Sponsor: Medical University of South Carolina • ClinicalTrials.gov ID: NCT06922617

Registry updated: 2026-09-03
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Description

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.

Interventions

  • Switching to E-Cigarette (Behavioral)
    Participants will receive twelve weeks of e-cigarette products with instructions to switch completely at switch date
  • Quitting using Medication (Drug)
    Participants will receive twelve weeks of FDA approved medication, combination NRT, with instructions to quit smoking cigarettes at quit date
  • Counseling (Behavioral)
    Participants will recieve brief weekly counseling to support their quit or switch attempt from cigarettes.

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 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.

Conditions

Tobacco Use Substance Use Disorders

Locations

  • MUSC Charleston — Charleston, South Carolina, United States
  • Shoreline Behavioral Health Services — Conway, South Carolina, United States
  • Phoenix Center — Greenville, South Carolina, United States
  • Behavioral Health Services of Pickens County — Pickens, South Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record