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

Evaluating a Tobacco Harm Reduction Strategy Among Clients Enrolled in Substance Use Disorder Treatment

Who can join

Ages 21 and older · All sexes · Healthy volunteers welcome

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 enrolled in outpatient SUD treatment and have an SUD diagnosis (past or current),
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 smoking cessation pharmacotherapy for the purposes of quitting smoking,
3. pregnant, breastfeeding, or trying to become pregnant,
4. contraindicated for NRT, and
5. currently using an ENDS on 20+ days out of the past 30.

About the study

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.

What is being tested

• Switching to E-Cigarette (behavioral)
• Quitting using Medication (drug)
• Counseling (behavioral)

Sponsor: Medical University of South Carolina · Participants: 240 · Started: Oct 17, 2025

Contact the study team

• Ela Williams · Phone: (843) 876-2090

Official record on ClinicalTrials.gov — NCT06922617

Locations in the U.S.

Conditions

• Drug Use and Addiction

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.