Evaluating a tobacco harm reduction strategy among clients enrolled in substance use disorder treatment - PROJECT ABSTRACT The prevalence of cigarette smoking among individuals with substance use disorders (SUD) is nearly three times higher than the prevalence of smoking among the general population. Individuals with SUD are more likely to die from smoking-related illness than from complications associated with substance use. In addition to the direct deleterious health effects of tobacco, continued smoking during SUD treatment is associated with worse substance-related outcomes and greater odds of relapse. However, few SUD programs offer tobacco cessation services and even when available, quit rates for individuals with SUD remain lower than the general population. Tobacco cessation interventions that have been shown to be effective in general SUD treatment settings have been multicomponent interventions that are time- and resource-intensive and expensive to implement. Thus, there is a strong need to implement low-intensity, appealing interventions that can reduce the harms from combustible tobacco among individuals in SUD treatment. Tobacco harm reduction strategies to reduce tobacco- related morbidity and mortality among an SUD treatment population are an appealing and pragmatic approach that may lead to greater uptake among clients, as well as program staff and leadership and may provide a viable alternative to better serve clients (when deemed appropriate, but not as a replacement to cessation). One harm reduction strategy is to ask smokers to switch completely to a non-combusted, electronic nicotine delivery system (ENDS). A handful of rigorous RCTs have now shown that switching to ENDS has the potential to promote abstinence from cigarettes better than traditional forms of pharmacotherapy in a general population of those who smoke and are motivated to quit. However, switching to ENDS as a harm reduction strategy has yet to be compared to pharmacotherapy among individuals with SUD (efficacy) and evaluated for acceptability and appropriateness among clients, program staff and leadership (implementation). Further, smoking cessation during SUD treatment has been shown to improve SUD outcomes and therefore it is critical to evaluate the impact of tobacco harm reduction interventions on SUD outcomes and engagement. This study proposes a Hybrid Type 1 effectiveness-implementation randomized controlled trial to evaluate the impact of switching to ENDS compared to quitting tobacco with an FDA-approved pharmacotherapy for smoking cessation (nicotine replacement therapy [NRT]). This trial will enroll 240 clients across 3 South Carolina outpatient SUD programs. Participants will be randomized 1:1 to either switch to an ENDS product or to quit smoking with NRT. We will 1) assess whether switching to ENDS better promotes biochemically-verified point prevalence abstinence from cigarettes at the 12-week end of treatment visit compared to NRT (Aim 1), 2) evaluate patient, provider, and organizational-level implementation outcomes using mixed methods according to the Proctor framework (Aim 2), and 3) assess SUD treatment outcomes and engagement between groups to test for non-inferiority (Aim 3).
