A Multi-Site Trial of Tirzepatide for Smoking Cessation
This multi-site clinical trial will generate data on the efficacy of tirzepatide for smoking cessation and associated outcomes (e.g., post-cessation weight gain) in treatment-seeking people who smoke (PWS) with overweight or obesity. A sample of 300 treatment-seeking people who smoke with body mass index of 25 kg/m2 or greater will be recruited from four geographic sites (University of Southern California, Yale University, University of Chicago, and University of Colorado Anschutz Medical Campus) to participate in a parallel-arm, dose-escalating, placebo-controlled trial. Participants will attend weekly clinic visits to receive subcutaneous tirzepatide or placebo over 16 weeks (Visit Weeks 1-16), followed by follow-up visits at Week 17 and Week 27. Medication will be prescribed according to the standard dose titration schedule for the first 16 weeks of treatment (initial dose: 2.5mg/week; final dose: 10mg/week). All participants will also receive nicotine patches.
• Age 21-65 years
• Body mass index ≥ 25kg/m2 at the baseline screening
• Reporting ≥10 cigarettes per day, on average, for the past 6 months and \> 2 year duration of smoking
• Interest in making a long-term cessation attempt within the next 30-60 days
• Willingness to receive study medication and standard-of-care smoking cessation supports (nicotine replacement therapy and a smoking cessation app)
• Ability to adhere to weekly visits and study procedures over the study period (i.e., no plans to move or travel for extended periods)
• Exhaled CO of \>5ppm at baseline
• Use of an acceptable birth control method for female participants\*
• Ability to read and communicate in English