๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-15

Multi-Site Trial of Tirzepatide for Smoking Cessation (NCT07602699)

A Multi-Site Trial of Tirzepatide for Smoking Cessation

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: University of Southern California

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Keck School of Medicine, University of Southern California โ€” Los Angeles, California

Age range: 21 Years to 65 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (4 Sites)

  • Keck School of Medicine, University of Southern California โ€” Los Angeles, California
  • University of Colorado Anschutz Medical Campus โ€” Aurora, Colorado
  • Yale University School of Medicine โ€” New Haven, Connecticut
  • University of Chicago Pritzker School of Medicine โ€” Chicago, Illinois

๐Ÿ“ž Contact the Study Coordinator

Phone: (213) 962-0698

Email: thomas.gilmore@usc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—