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

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use; Substance Use Disorders
• Intervention / Treatment: Drug: Quitting using Medication; Behavioral: Counseling; Behavioral: Switching to E-Cigarette

Detailed Description

Tobacco use rates among those with substance use disorders (SUD) are disproportionately high compared to the general population. While rates of tobacco use continue to decline in the general population, use rates among those with SUD have remained stagnant, with only slight declines noted in recent years. Despite this, clients enrolled in SUD treatment rarely engage in evidence-based tobacco treatment and many do not quit using tobacco during treatment. Continued tobacco use during SUD treatment results in worse substance-related treatment outcomes, as well as premature morbidity and mortality. Yet, surprisingly few rigorous randomized controlled trials (RCT) have been conducted to assess tobacco cessation in this population. Strategies to reduce the harmful effects of continued tobacco use in a SUD treatment population are urgently needed.

Importantly, those in SUD treatment who smoke cigarettes endorse an interest in quitting smoking, but quit rates are lower among a SUD population compared to the general population by about half. For example, within our own hospital system at the Medical University of South Carolina (MUSC), which employs an opt-out tobacco cessation approach for all inpatients, those with mental health diagnoses, including SUD, were less likely to report tobacco abstinence at 30-day follow-up post-discharge, compared to those without mental health diagnoses. There is a clear public health need to address the harmful impact of combustible tobacco use among those enrolled in treatment for SUD and ensure that these strategies, should they be efficacious in reducing harm, are acceptable and feasible for SUD clients, program staff and leadership. The need to address combustible tobacco use in this population has been present for decades and yet advances in this area have been minimal. Those in SUD treatment are still disproportionately impacted by the harms of combustible tobacco, which may be due, in large part, to the barriers that exist in treating tobacco as part of SUD standard of care.

Participants will be randomized 1:1 to: 1) switch exclusively to ENDS, or 2) quit tobacco with NRT. The aims of this study are to: 1) evaluate if switching to ENDS leads to greater rates of 7-day biologically confirmed point prevalence abstinence (PPA) from cigarette smoking at 12 weeks compared to quitting with NRT among those enrolled in SUD treatment (Aim 1), 2) evaluate patient, provider, and organizational-level implementation outcomes using mixed methods according to the Proctor framework, which describes barriers and facilitators of successful implementation of an intervention (Aim 2), and 3) assess the impact of switching to ENDS compared to quitting with NRT on SUD treatment outcomes and engagement to test for non-inferiority over 12 weeks (Aim 3).

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ela Williams; Phone Number: (843) 876-2090; Email: williela@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • MUSC Charleston, Center for Drug and Alcohol Problems
      • Contact: Ela Williams; Phone Number: 843-876-2090; Email: williela@musc.edu
    • Conway, South Carolina, United States, 29526
      • Recruiting
      • Shoreline Behavioral Health Services
      • Contact: April Lehman; Phone Number: 843-698-2767; Email: alehman@shorelinebhs.org
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Phoenix Center
      • Contact: Daniel Moss; Phone Number: 864-898-2992; Email: mossd@musc.edu
    • Pickens, South Carolina, United States, 29671
      • Recruiting
      • Behavioral Health Services of Pickens County
      • Contact: Elizabeth Chapman, LPC; Phone Number: 864-898-2992; Email: chapmanb@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 pharmacotherapy with smoking cessation efficacy,
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medication; This 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.	Drug: Quitting using Medication; Participants will receive twelve weeks of FDA approved medication, combination NRT, with instructions to quit smoking cigarettes at quit date; Behavioral: Counseling; Participants will recieve brief weekly counseling to support their quit or switch attempt from cigarettes.
Experimental: Switching to an E-Cigarette; This arm includes participants randomly assigned to the E-Cigarette Group. Participants will receive a study-provided e-cigarette product for 12 weeks.	Behavioral: Counseling; Participants will recieve brief weekly counseling to support their quit or switch attempt from cigarettes.; Behavioral: Switching to E-Cigarette; Participants will receive twelve weeks of e-cigarette products with instructions to switch completely at switch date

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the intervention	4-item Acceptability of the Intervention Measure where higher scores indicate greater acceptability (range 1-5)	12 weeks
Number of negative urine drug screens	Number of negative urine drug screens (for the primary substance of use) submitted during the 12 week treatment	12 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Substance-Related Disorders; Tobacco Use; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Counseling
• Other Study ID Numbers: Pro00136062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No