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Multi-Site Trial of Tirzepatide for Smoking Cessation
Sponsor: 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.
Official title: A Multi-Site Trial of Tirzepatide for Smoking Cessation
Key Details
Gender
All
Age Range
21 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-06-05
Completion Date
2028-09
Last Updated
2026-07-17
Healthy Volunteers
No
Conditions
Interventions
Tirzepatide
Participants will receive tirzepatide (subcutaneous injection) at doses of 2.5mg for Weeks 1-4, 5mg for Weeks 5-8, 7.5mg for Weeks 9-12, and 10mg for Weeks 13-16
Placebo
Participants will receive placebo (saline) injections for Weeks 1-16
Locations (4)
Keck School of Medicine, University of Southern California
Los Angeles, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Chicago Pritzker School of Medicine
Chicago, Illinois, United States