Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
NCT06922617

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

Led by Medical University of South Carolina · Updated on 2026-04-03

240

Participants Needed

4

Research Sites

150 weeks

Total Duration

On this page

Sponsors

M

Medical University of South Carolina

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 21 years of age or older
  • Smoke at least 5 cigarettes daily or nearly daily for the past 6 months
  • Enrolled in outpatient substance use disorder treatment with a past or current diagnosis
  • Breath carbon monoxide sample of 7 parts per million or higher at screening
  • Positive instant-read urinary cotinine test
  • At least one previous unsuccessful quit attempt for smoking
  • Interest in reducing smoking, quitting, or switching to a less harmful product
  • If female, agrees to use birth control during the study
Not Eligible

You will not qualify if you...

  • Any significant or unstable medical or psychiatric condition affecting safety
  • Currently using pharmacotherapy effective for smoking cessation
  • Pregnant, breastfeeding, or trying to become pregnant
  • Contraindicated for nicotine replacement therapy
  • Currently using electronic nicotine delivery systems (ENDS) on 20 or more days in the past 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

MUSC Charleston, Center for Drug and Alcohol Problems

Charleston, South Carolina, United States, 29425

Actively Recruiting

2

Shoreline Behavioral Health Services

Conway, South Carolina, United States, 29526

Actively Recruiting

3

Phoenix Center

Greenville, South Carolina, United States, 29607

Actively Recruiting

4

Behavioral Health Services of Pickens County

Pickens, South Carolina, United States, 29671

Actively Recruiting

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Research Team

E

Ela Williams

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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