NCT06922617 · Medical University of South Carolina
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
(STEPS)
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Switching to E-Cigarette
Participants will receive twelve weeks of e-cigarette products with instructions to switch completely at switch date
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Charleston, South Carolina
- Conway, South Carolina
- Greenville, South Carolina
- Pickens, South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations