STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking (NCT06922617) | Clinical Trial Compass
RecruitingNot Applicable
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
United States240 participantsStarted 2025-10-17
Plain-language 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 will include five in-person study visits and eleven virtual assessments. Participants will also complete a short daily diary on their phones each day for the first twelve weeks. To qualify, participants must be within 30 days of SUD treatment program admission. This study is being conducted at three outpatient SUD treatment programs across South Carolina. These sites include: 1) the Center for Drug and Alcohol Problems (CDAP) in Charleston, SC, 2) Behavioral Health Services of Pickens County (BHSPC) in Pickens, SC, and 3) Shoreline Behavioral Health Services in Conway, SC. the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and the Medical University of South Carolina in Florence, SC.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. 21+ years of age,
✓. smoke at least 5 cigarettes per day daily or near daily for the past 6 months,
✓. be enrolled in outpatient SUD treatment and have an SUD diagnosis (past or current),
✓. must submit a breath CO sample of ≥ 7 parts per million at screening and a positive instant-read urinary cotinine test,
✓. have had at least one failed smoking quit attempt in their lifetime,
✓. have interest in reducing smoking, quitting smoking, or switching to a less harmful product, and
✓. if female, agrees to use a form of birth control during the study.
Exclusion criteria
✕. any significant or unstable medical or psychiatric concern that would affect safety,
✕. current use of pharmacotherapy with smoking cessation efficacy,