Tobacco UseSTEPSNCT06922617
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
A study testing Switching to E-Cigarette, Quitting using Medication and Counseling in people with Tobacco Use and Substance Use Disorders, run by Medical University of South Carolina at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Substance Use Disorders
- What is being tested?
- Switching to E-Cigarette, Quitting using Medication and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Oct 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21+ 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.
Who cannot join
- any significant or unstable medical or psychiatric concern that would affect safety,
- current use of smoking cessation pharmacotherapy for the purposes of quitting smoking,
- pregnant, breastfeeding, or trying to become pregnant,
- contraindicated for NRT, and
- currently using an ENDS on 20+ days out of the past 30.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
MUSC Charleston
Charleston, South Carolina, 29425
Ela Williams, 843-876-2090, williela@musc.edu
- Recruiting
Shoreline Behavioral Health Services
Conway, South Carolina, 29526
April Lehman, 843-698-2767, alehman@shorelinebhs.org
- Recruiting
Phoenix Center
Greenville, South Carolina, 29607
Daniel Moss, 864-898-2992, mossd@musc.edu
- Recruiting
Behavioral Health Services of Pickens County
Pickens, South Carolina, 29671
Elizabeth Chapman, LPC, 864-898-2992, chapmanb@musc.edu
About this study
Official title: 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 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.
Read the 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).
- Conditions
- Tobacco Use, Substance Use Disorders
- Being tested
- Switching to E-Cigarette, Quitting using Medication, Counseling
- Medical subject headings
- Tobacco Use, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switching to E-CigaretteBehavioural
Participants will receive twelve weeks of e-cigarette products with instructions to switch completely at switch date
Quitting using MedicationDrug
Participants will receive twelve weeks of FDA approved medication, combination NRT, with instructions to quit smoking cigarettes at quit date
CounselingBehavioural
Participants will recieve brief weekly counseling to support their quit or switch attempt from cigarettes.
| Study group | Role | What they receive |
|---|---|---|
| Medication | Experimental | 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. Receives: Drug: Quitting using Medication; Behavioral: Counseling |
| Switching to an E-Cigarette | Experimental | This arm includes participants randomly assigned to the E-Cigarette Group. Participants will receive a study-provided e-cigarette product for 12 weeks. Receives: Behavioral: Switching to E-Cigarette; Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence from smoking at end of treatment
7-day biologically confirmed point prevelance abstinence from cigarette smoking at Week 12 end of treatment visit
Measured: 7 days
Secondary outcomes (2)
Acceptability of the intervention
4-item Acceptability of the Intervention Measure where higher scores indicate greater acceptability (range 1-5)
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start17 Oct 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Erin McClure, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922617
- Sponsor's protocol ID
- Pro00136062
- Acronym
- STEPS
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Tobacco Harm Reduction Strategy Among Clients Enrolled in Substance Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT06922617
- Acronym / sponsor ID
- STEPS / Pro00136062
- Conditions
- Tobacco Use, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication | Experimental | Drug: Quitting using Medication, Behavioral: CounselingThis 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 | Experimental | Behavioral: Switching to E-Cigarette, Behavioral: CounselingThis arm includes participants randomly assigned to the E-Cigarette Group. Participants will receive a study-provided e-cigarette product for 12 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 21+ 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,
Key exclusion criteria (5 listed)
- any significant or unstable medical or psychiatric concern that would affect safety,
- current use of smoking cessation pharmacotherapy for the purposes of quitting smoking,
- pregnant, breastfeeding, or trying to become pregnant,
- contraindicated for NRT, and
- currently using an ENDS on 20+ days out of the past 30.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Switching to E-CigaretteParticipants will receive twelve weeks of e-cigarette products with instructions to switch completely at switch date | Behavioural | Switching to an E-Cigarette |
| Quitting using MedicationParticipants will receive twelve weeks of FDA approved medication, combination NRT, with instructions to quit smoking cigarettes at quit date | Drug | Medication |
| CounselingParticipants will recieve brief weekly counseling to support their quit or switch attempt from cigarettes. | Behavioural | Medication, Switching to an E-Cigarette |
Primary outcome
Abstinence from smoking at end of treatment
Time frame: 7 days
7-day biologically confirmed point prevelance abstinence from cigarette smoking at Week 12 end of treatment visit
2 secondary outcomes
Acceptability of the intervention
Time frame: 12 weeks
Number of negative urine drug screens
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Switching to E-Cigarette, Quitting using Medication and Counseling in people with Tobacco Use and Substance Use Disorders, run by Medical University of South Carolina at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ela Williams ((843) 876-2090, williela@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence from smoking at end of treatment (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.