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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06922617
Status
Recruiting
Apply to this trial

Conditions

  • Substance Use Disorders
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Switching to E-Cigarette — BEHAVIORAL
    Participants will receive twelve weeks of e-cigarette products with instructions to switch completely at switch date
  • Quitting using Medication — DRUG
    Participants will receive twelve weeks of FDA approved medication, combination NRT, with instructions to quit smoking cigarettes at quit date
  • Counseling — BEHAVIORAL
    Participants will recieve brief weekly counseling to support their quit or switch attempt from cigarettes.

Study Details

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 Dates

Start date
Oct 17, 2025
Status verified
Apr 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Medication
    This arm includes participants randomly assigned to the medication group. Participants will receive combination nicotine replacement therapy (NRT). The NRT will consist of transdermal patches and nicotine lozenges. Participants will receive study product for 12 weeks.
  • Experimental: Switching to an E-Cigarette
    This arm includes participants randomly assigned to the E-Cigarette Group. Participants will receive a study-provided e-cigarette product for 12 weeks.

Primary Outcome Measure

Abstinence from smoking at end of treatment [ Time Frame: 7 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
MUSC Charleston, Center for Drug and Alcohol ProblemsCharlestonSouth Carolina29425
Ela Williams
[email protected]
843-876-2090
Shoreline Behavioral Health ServicesConwaySouth Carolina29526
April Lehman
[email protected]
843-698-2767
Phoenix CenterGreenvilleSouth Carolina29607
Daniel Moss
[email protected]
864-898-2992
Behavioral Health Services of Pickens CountyPickensSouth Carolina29671
Elizabeth Chapman, LPC
[email protected]
864-898-2992

Find similar trials in Charleston, SC

By research site
MUSC Charleston, Center for Drug and Alcohol Problems· Charleston, SCShoreline Behavioral Health Services· Conway, SCPhoenix Center· Greenville, SCBehavioral Health Services of Pickens County· Pickens, SC

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