Status:
RECRUITING
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use
Substance Use Disorders
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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...
Detailed Description
Tobacco use rates among those with substance use disorders (SUD) are disproportionately high compared to the general population. While rates of tobacco use continue to decline in the general populatio...
Eligibility Criteria
Inclusion
- 21+ years of age,
- smoke at least 5 cigarettes per day daily or near daily for the past 6 months,
- be within 90 days of the first outpatient SUD treatment session and have an active SUD diagnosis,
- 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
- 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 10+ days out of the past 30.
Key Trial Info
Start Date :
October 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06922617
Start Date
October 17 2025
End Date
September 1 2028
Last Update
October 20 2025
Active Locations (3)
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1
MUSC Charleston, Center for Drug and Alcohol Problems
Charleston, South Carolina, United States, 29425
2
Shoreline Behavioral Health Services
Conway, South Carolina, United States, 29526
3
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671