STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Recruiting now · Not applicable
Conditions studied: Tobacco Use, Substance Use Disorders
In brief
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.
Key facts
- Study ID
- NCT06922617
- Run by
- Medical University of South Carolina
- People needed
- 240
- Starts
- 2025-10-17
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-04-03
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- any significant or unstable medical or psychiatric concern that would affect safety,
- current use of pharmacotherapy with smoking cessation efficacy,
- pregnant, breastfeeding, or trying to become pregnant,
- contraindicated for NRT, and
- currently using an ENDS on 20+ days out of the past 30.
Where it is running
- MUSC Charleston, Center for Drug and Alcohol Problems — Charleston, South Carolina, United States (enrolling)
- Shoreline Behavioral Health Services — Conway, South Carolina, United States (enrolling)
- Phoenix Center — Greenville, South Carolina, United States (enrolling)
- Behavioral Health Services of Pickens County — Pickens, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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