STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
STEPS
Evaluating a Tobacco Harm Reduction Strategy Among Clients Enrolled in Substance Use Disorder Treatment
1 other identifier
interventional
240
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedStudy Start
First participant enrolled
October 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
March 4, 2026
March 1, 2026
2.9 years
April 3, 2025
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Abstinence from smoking at end of treatment
7-day biologically confirmed point prevelance abstinence from cigarette smoking at Week 12 end of treatment visit
7 days
Secondary Outcomes (2)
Acceptability of the intervention
12 weeks
Number of negative urine drug screens
12 weeks
Study Arms (2)
Medication
EXPERIMENTALThis arm includes participants randomly assigned to the medication group. Participants will receive combination nicotine replacement therapy (NRT). The NRT will consist of transdermal patches and nicotine lozenges. Participants will receive study product for 12 weeks.
Switching to an E-Cigarette
EXPERIMENTALThis arm includes participants randomly assigned to the E-Cigarette Group. Participants will receive a study-provided e-cigarette product for 12 weeks.
Interventions
Participants will receive twelve weeks of e-cigarette products with instructions to switch completely at switch date
Participants will receive twelve weeks of FDA approved medication, combination NRT, with instructions to quit smoking cigarettes at quit date
Participants will recieve brief weekly counseling to support their quit or switch attempt from cigarettes.
Eligibility Criteria
You may qualify if:
- + 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,
- have had at least one failed smoking quit attempt in their lifetime,
- have interest in reducing smoking, quitting smoking, or switching to a less harmful product, and
- if female, agrees to use a form of birth control during the study.
You may not qualify if:
- 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
- currently using an ENDS on 20+ days out of the past 30.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
MUSC Charleston, Center for Drug and Alcohol Problems
Charleston, South Carolina, 29425, United States
Shoreline Behavioral Health Services
Conway, South Carolina, 29526, United States
Phoenix Center
Greenville, South Carolina, 29607, United States
Behavioral Health Services of Pickens County
Pickens, South Carolina, 29671, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor-Faculty
Study Record Dates
First Submitted
April 3, 2025
First Posted
April 10, 2025
Study Start
October 17, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
March 4, 2026
Record last verified: 2026-03