Harm Reduction for Smokers With Mental Illness: Randomized Trial of E-cigarette Provision With or Without Behavioral Support to Boost Switching

What this Trial Is About

This research aims to evaluate the effectiveness of providing e-cigarettes with or without behavioral support through telehealth to reduce harm among smokers with mental illness who cannot quit smoking and are not ready to pursue cessation treatment. The study focuses on smokers diagnosed with conditions such as schizophrenia, bipolar disorder, major depressive disorder, posttraumatic stress disorder, or other anxiety disorders. It also explores self-regulation mechanisms like using e-cigarettes instead of cigarettes to manage stress or distress and self-efficacy as factors influencing behavior change. Participants will be randomly assigned to one of two groups: one group receives a supply of NJOY Daily e-cigarettes alone for the first 8 weeks, while the other group receives both e-cigarettes and structured behavioral support called SWITCH IT, which includes 7 to 10 coaching sessions delivered over the same 8-week period. SWITCH IT participants may also have opportunities for supported visits to explore different e-cigarette options during weeks 4 and 6. The study does not involve a placebo group and uses single masking. Throughout the study, researchers will assess changes in tobacco-related markers such as urine NNAL levels and carbon monoxide (CO) levels from baseline to 8 weeks and then to 26 weeks. Self-reported cigarette use will also be monitored from baseline through 16 weeks. Participants' smoking habits, biological samples, and behavioral responses will be evaluated to determine the impact of the interventions. The study is sponsored by Dartmouth-Hitchcock Medical Center and will run until March 2028.

Harm Reduction for Smokers With Mental Illness