Clinical trial NCT06922617: STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Official title: Evaluating a Tobacco Harm Reduction Strategy Among Clients Enrolled in Substance Use Disorder Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tobacco Use
Substance Use Disorders
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-10
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: Inclusion Criteria:

* 21+ years of age,
* Smoke at least 5 cigarettes per day regularly for the past 6 months,
* Be within 30 days of SUD treatment program admission,
* Must submit a breath CO sample of ≥ 7 parts per million at screening and a positive instant-read urinary cotinine test (metabolite of nicotine, cut off of 200 ng/ml),
* Have had at least one failed quit attempt in their lifetime, and
* Have interest in reducing smoking, quitting smoking, or switching to a less harmful product.

Exclusion Criteria:

* Any significant or unstable medical or psychiatric concern that would affect safety,
* Current use of pharmacotherapy for smoking cessation,
* Pregnant, breastfeeding, or trying to become pregnant,
* Contraindicated for NRT, and
* Currently using an ENDS on 20+ days out of the past 30.

Primary outcomes:
measure: Abstinence from smoking at end of treatment
timeFrame: 7 days
Secondary outcomes:
measure: Acceptability of the intervention
timeFrame: 12 weeks
measure: Number of negative urine drug screens
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Charleston, Center for Drug and Alcohol Problems
state: South Carolina
city: Conway
country: United States
facility: Shoreline Behavioral Health Services
state: South Carolina
city: Pickens
country: United States
facility: Behavioral Health Services of Pickens County
state: South Carolina
Study officials:
References: