Study Comparing E-Cigarettes and Nicotine Replacement Therapy to Help People in Substance Use Disorder Treatment Quit Smoking

What this Trial Is About

This research aims to evaluate whether switching completely to e-cigarettes can help people who smoke and are undergoing treatment for substance use disorders SUD quit smoking, compared to using FDA-approved nicotine replacement therapy NRT such as patches and lozenges. Tobacco use remains high among those with SUD despite declines in the general population, and quitting smoking during SUD treatment is challenging but important for better health outcomes. The study also seeks to understand implementation barriers and how these treatments affect SUD progress over 12 weeks. Participants will be randomly assigned to one of two groups one group will receive twelve weeks of e-cigarette products with instructions to switch completely from cigarettes, while the other group will receive twelve weeks of combination NRT patches plus nicotine lozenges to support quitting smoking. Both groups will also receive brief weekly counseling to support their quit or switch attempts. The study period includes 12 weeks of treatment with follow-up assessments. Participants will be involved for six months, including five in-person visits and eleven virtual assessments. They will complete a daily diary on their phones for the first twelve weeks. Researchers will monitor smoking abstinence verified biologically at the end of treatment, evaluate how acceptable the treatments are, and assess substance use outcomes through urine drug screens. Safety and participant engagement will also be tracked throughout the study.

STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking