This clinical trial compares switching to electronic nicotine delivery systems (ENDS) to nicotine replacement therapy (NRT) for the improvement of smoking cessation (quit smoking) in patients receiving treatment for substance use disorders (SUD). Tobacco use rates among those with SUD are unequally high compared to the general population. Individuals enrolled in SUD treatment rarely engage in tobacco treatment and many do not quit using tobacco during treatment. Continued tobacco use during SUD treatment may result in worse substance-related treatment outcomes, as well as disease and death. Strategies to reduce the harmful effects of continued tobacco use during SUD treatment are greatly needed. ENDS is a battery-powered electronic device designed to deliver a nicotine-containing liquid solution for inhalation. They are not burned or ignited and may reduce harm because most of the harm from smoking comes from the burning of tobacco. NRT is a type of treatment that uses special products, such as patches or lozenges, to give small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking. Switching to ENDS may be a more effective way to improve smoking cessation in patients receiving SUD treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT06922617.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Erin A McClure
Phone: 843-792-7192
PRIMARY OBJECTIVES:
I. 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.
II. Among study participants, evaluate patient implementation outcomes using mixed methods according to the Proctor framework.
III. Assess the impact of switching to ENDS compared to quitting with NRT on SUD treatment outcomes and retention to test for non-inferiority of negative urine drug screens, drug free days, and time engaged in SUD treatment during the 12-week study.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients attend a cessation counseling session over 5-10 minutes at baseline and receive ENDS and use as desired and continue to smoke for 7 days. Starting on day 7, patients stop smoking completely and switch to ENDS and use as much as needed for 12 weeks in the absence of unacceptable toxicity. Patients may also attend additional cessation counseling sessions and receive additional tobacco standard of care clinical practices as needed on study.
GROUP II: Patients attend a cessation counseling session over 5-10 minutes at baseline and receive combination NRT, consisting of transdermal nicotine patches and nicotine lozenges, and use as desired and continue to smoke for 7 days. Starting on day 7, patients stop smoking completely and switch to combination NRT and use as per package instructions for 12 weeks in the absence of unacceptable toxicity. Patients may also attend additional cessation counseling sessions and receive additional tobacco standard of care clinical practices as needed on study.
Additionally, all patients undergo urine sample collection throughout the study.
After completion of study intervention, patients are followed up at weeks 16 and 24.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMedical University of South Carolina
Principal InvestigatorErin A McClure
