Actively Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Led by Medical University of South Carolina · Updated on 2026-04-03
240
Participants Needed
4
Research Sites
150 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 21 years of age or older
- Smoke at least 5 cigarettes daily or nearly daily for the past 6 months
- Enrolled in outpatient substance use disorder treatment with a past or current diagnosis
- Breath carbon monoxide sample of 7 parts per million or higher at screening
- Positive instant-read urinary cotinine test
- At least one previous unsuccessful quit attempt for smoking
- Interest in reducing smoking, quitting, or switching to a less harmful product
- If female, agrees to use birth control during the study
You will not qualify if you...
- Any significant or unstable medical or psychiatric condition affecting safety
- Currently using pharmacotherapy effective for smoking cessation
- Pregnant, breastfeeding, or trying to become pregnant
- Contraindicated for nicotine replacement therapy
- Currently using electronic nicotine delivery systems (ENDS) on 20 or more days in the past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
MUSC Charleston, Center for Drug and Alcohol Problems
Charleston, South Carolina, United States, 29425
Actively Recruiting
2
Shoreline Behavioral Health Services
Conway, South Carolina, United States, 29526
Actively Recruiting
3
Phoenix Center
Greenville, South Carolina, United States, 29607
Actively Recruiting
4
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671
Actively Recruiting
Research Team
E
Ela Williams
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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