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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Apr 3, 2025

Keywords

ClinConnect Summary

The STEPS trial is studying whether e-cigarettes, or nicotine vapes, can help people who smoke and are receiving treatment for substance use disorders (SUD) quit smoking. The trial compares the effectiveness of e-cigarettes to FDA-approved medications like nicotine patches and lozenges. If you participate, the study will last for 6 months and involve five in-person visits and eleven virtual check-ins. You will also keep a short daily diary on your phone for the first twelve weeks to track your progress.

To join the trial, you must be at least 21 years old, smoke at least 5 cigarettes a day for the past six months, and be within 30 days of starting an SUD treatment program. You should also have tried to quit smoking before and want to either quit or switch to a less harmful product. However, if you are pregnant, have certain medical issues, or are already using smoking cessation medications, you won't be eligible. This study is taking place at three outpatient treatment centers in South Carolina, and it aims to find better ways to help people quit smoking while they manage their substance use disorders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 21+ years of age,
• • 2. smoke at least 5 cigarettes per day daily or near daily for the past 6 months,
• • 3. be within 90 days of the first outpatient SUD treatment session and have an active SUD diagnosis,
• • 4. must submit a breath CO sample of ≥ 7 parts per million at screening and a positive instant-read urinary cotinine test,
• • 5. have had at least one failed smoking quit attempt in their lifetime,
• • 6. have interest in reducing smoking, quitting smoking, or switching to a less harmful product, and
• • 7. if female, agrees to use a form of birth control during the study.
• Exclusion Criteria:
• • 1. any significant or unstable medical or psychiatric concern that would affect safety,
• • 2. current use of pharmacotherapy with smoking cessation efficacy,
• • 3. pregnant, breastfeeding, or trying to become pregnant,
• • 4. contraindicated for NRT, and
• • 5. currently using an ENDS on 10+ days out of the past 30.