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

RecruitingNAAges 21 Years - anyAllMedical University of South Carolina
NCT06922617 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Switching to E-Cigarette
  • Quitting using Medication
  • Counseling
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Where

4 sites
MUSC Charleston
Charleston, United States
Shoreline Behavioral Health Services
Conway, United States
Phoenix Center
Greenville, United States
Behavioral Health Services of Pickens County
Pickens, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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