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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

Qualifiers

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,

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Switching to E-Cigarette
  • Quitting using Medication
  • Counseling

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator