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Life sciences · Interventional Study
ClinicalTrials.gov · November 9, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05030272). This is a study registration, not published results. Lead sponsor: Wake Forest University Health Sciences. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 343 participants (ACTUAL). Conditions: Tobacco Use Disorder, Mental Illness, Recurring Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Persistent Depressive Disorder. Interventions: DEVICE: Quit on the Go App (formerly "Learn to Quit " App); BEHAVIORAL: Brief advice; DRUG: Nicotine patch; BEHAVIORAL: Smartphone coaching; DRUG: Nicotine gum; DRUG: Nicotine Lozenges. Primary outcome measures: Bio-verified 7-day point-prevalence abstinence at 24 weeks , At 24 weeks from Baseline. Brief summary: The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).