A Multi-Site Trial of Tirzepatide for Smoking Cessation
University of Southern California
Summary
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.
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 21-65 years 2. Body mass index ≥ 25kg/m2 at the baseline screening 3. Reporting ≥10 cigarettes per day, on average, for the past 6 months and \> 2 year duration of smoking 4. Interest in making a long-term cessation attempt within the next 30-60 days 5. Willingness to receive study medication and standard-of-care smoking cessation supports (nicotine replacement therapy and a smoking cessation app) 6. Ability to adhere to weekly visits and study procedures over the study period (i.e., no plans to move or travel for extended periods) 7. Exhaled CO of \>5ppm at baselin…