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

Study acronym: STEPS
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Study completion pushed from Sep 1, 2028 to Dec 1, 2028
    • Eligibility criteria expanded, about 12 words
  2. Study sites revised (4)
    • Eligibility criteria expanded, about 4 words
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Study sites: 3 to 4v9
  5. Eligibility criteria shortened, about 3 wordsv8
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2025 to Oct 17, 2025
    • Eligibility criteria expanded, about 18 words
    • Site details revised at 3 of 3 sites
    v7
  2. Start date: Sep 22, 2025 to Nov 1, 2025v6
  3. Start date: Sep 2, 2025 to Sep 22, 2025v5
  4. Start date: Aug 1, 2025 to Sep 2, 2025v4
  5. Start date: May 1, 2025 to Aug 1, 2025v3
  6. Primary endpoint revised
    • Secondary endpoints revised (2)
    • Site contacts updated at 1 of 3 sites
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 includes 14 weekly study visits and 2 follow-up study visits (in-person, but virtual study visits are possible). Participants will also complete a short daily diary on their phones each day for the first twelve weeks. To qualify, participants (ages 21+) must be enrolled in an outpatient substance use disorder (SUD) treatment program. The study is being done in four regions across South Carolina: Charleston, Pickens/Easley, Conway, and Greenville.
Trial Details
NCT Number NCT06922617
Lead Sponsor Medical University of South Carolina
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Tobacco Use, Substance Use Disorders
Related terms Substance-Related Disorders, Tobacco Use
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov