Multi-Site Trial of Tirzepatide for Smoking Cessation

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT07602699
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Smoking Behaviors
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    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 — OTHER
    Participants will receive placebo (saline) injections for Weeks 1-16

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
  • Placebo Comparator: Placebo

Primary Outcome Measure

7-day point prevalence abstinence [ Time Frame: From baseline through 16 weeks of treatment (final assessment at Week 17 visit) and at 6 months after the target quit date (assessed at Week 27 visit) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Keck School of Medicine, University of Southern CaliforniaLos AngelesCalifornia90033
Tom Gilmore
[email protected]
213-962-0698
Christian Hendershot, Ph.D. (PRINCIPAL_INVESTIGATOR)
University of Colorado Anschutz Medical CampusAuroraColorado80045
[email protected]
303-724-3196
Joseph Schacht, PhD (PRINCIPAL_INVESTIGATOR)
Yale University School of MedicineNew HavenConnecticut06510
Sabrina Coppola
[email protected]
203-737-2827
Sherry McKee, PhD (PRINCIPAL_INVESTIGATOR)
University of Chicago Pritzker School of MedicineChicagoIllinois60637
Claire Wellendorf
[email protected]
773-834-2244
Andrea King (PRINCIPAL_INVESTIGATOR)

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By research site
Keck School of Medicine, University of Southern California· Los Angeles, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COYale University School of Medicine· New Haven, CTUniversity of Chicago Pritzker School of Medicine· Chicago, IL

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