Smoking CessationPhase 2NCT07602699
Multi-Site Trial of Tirzepatide for Smoking Cessation
A Phase 2 study testing Tirzepatide in people with Smoking Cessation and Smoking Behaviors, run by University of Southern California at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Smoking Cessation, Smoking Behaviors
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Jun 2026to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Exhaled CO of >5ppm at baseline
- Use of an acceptable birth control method for female participants*
- Ability to read and communicate in English
Who cannot join
- BMI < 25 kg/m2 at screening
- History of diabetes, diabetes-attributable medical conditions, or HbA1c ≥6.5% at baseline
- Recent (past 90 days) active suicidal ideation or lifetime history of suicide attempt
- Current treatment for psychotic disorders or mood disorders with psychotic features (e.g., schizophrenia, schizoaffective disorder, depression with psychotic features), current treatment for bipolar disorder (with or without psychotic features), or current secondary psychosis due to substance use or another medical condition
- Meeting DSM-5 criteria for a current (past 12 months) substance use disorder other than tobacco use disorder, mild or moderate cannabis use disorder, or mild or moderate alcohol use disorder.
- Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A positive screen for opioids will be allowed if the participant is prescribed an opioid replacement therapy medication and can provide documentation.
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- Past 30-day initiation of psychiatric medications (e.g., SSRIs) or changes to medication dose
- Treatment with tirzepatide or another GLP-1RA medication in the prior 6 months
- Current (past month) treatment with other weight loss, diabetes, or smoking cessation medications (varenicline or bupropion; excluding nicotine replacement products)
- Severe GI disease (e.g., gastroparesis, ulcerative colitis).
- History of gastric bypass surgery or other surgeries of the stomach
- Any health condition or treatment/medication that would preclude the use of tirzepatide or NRT, in the opinion of the study physician, including severe cardiovascular disease
- History of chronic pancreatitis or acute pancreatitis in the last 6 months
- Currently nursing, pregnant, or anticipating pregnancy
- History of diabetic retinopathy, proliferative retinopathy, or maculopathy
- Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (>5x upper limit of normal range)
- History of malignant neoplasms in the last 5 years, except non-melanoma skin cancer
- Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule)
- Currently enrolled in another clinical study involving an investigational product
- Currently living in the same household as someone taking a GLP-1 medication, or living with a current or former participant in the present trial
- Planned surgical procedures requiring anesthesia during the planned study medication period
- Personal or family history of medullary thyroid cancer
- Personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Treatment with other weight loss (e.g., phentermine), or FDA-approved, non-NRT smoking cessation therapies (varenicline, bupropion) or FDA-approved AUD medications (naltrexone, acamprosate, disulfiram) or off-label AUD medications (e.g., topiramate) in the past 90 days
- Any health condition or treatment/medication that would preclude use of tirzepatide or NRT, in the opinion of the site physicians including thyroid enlargement.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Kristen Raymond, 303-724-3196, kristen.raymond@cuanschutz.edu
Joseph Schacht, PhD
- Recruiting
University of Chicago Pritzker School of Medicine
Chicago, Illinois, 60637
Claire Wellendorf, 773-834-2244, cwellendorf@bsd.uchicago.edu
Andrea King, PhD
- Recruiting
Keck School of Medicine, University of Southern California
Los Angeles, California, 90033
Tom Gilmore, 213-962-0698, thomas.gilmore@usc.edu
Christian Hendershot, Ph.D.
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06510
Sabrina Coppola, 203-737-2827, Sabrina.coppola@yale.edu
Sherry McKee, PhD
About this study
Official title: 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.
- Conditions
- Smoking Cessation, Smoking Behaviors
- Being tested
- Tirzepatide, Placebo
- Keywords
- Addiction, GLP-1, Tirzepatide, Substance Use Disorder
- Medical subject headings
- Smoking Cessation, Smoking, Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
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
PlaceboOther
Participants will receive placebo (saline) injections for Weeks 1-16
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Not described Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence
Biochemically verified abstinence from cigarette smoking
Measured: 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)
Secondary outcomes (2)
Cigarettes per day
Measured: From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Weekly cigarette craving
Cigarette craving in the past week will be measured using the craving scale of the Wisconsin Smoking Withdrawal Scale, containing 4 items, each scored on a scale of 1-4. Items are summed to generate a score.
Measured: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start5 Jun 2026
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602699
- Sponsor's protocol ID
- HS-25-00642
- Other IDs
- U01DA064384
- Status last verified
- Jul 2026
- First submitted
- 11 May 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Trial of Tirzepatide for Smoking Cessation
- ClinicalTrials.gov ID
- NCT07602699
- Acronym / sponsor ID
- HS-25-00642
- Conditions
- Smoking Cessation, Smoking Behaviors
- Keywords
- Addiction, GLP-1, Tirzepatide, Substance Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: Tirzepatide |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (25 listed)
- BMI < 25 kg/m2 at screening
- History of diabetes, diabetes-attributable medical conditions, or HbA1c ≥6.5% at baseline
- Recent (past 90 days) active suicidal ideation or lifetime history of suicide attempt
- Current treatment for psychotic disorders or mood disorders with psychotic features (e.g., schizophrenia, schizoaffective disorder, depression with psychotic features), current treatment for bipolar disorder (with or without psychotic features), or current secondary psychosis due to substance use or another medical condition
- Meeting DSM-5 criteria for a current (past 12 months) substance use disorder other than tobacco use disorder, mild or moderate cannabis use disorder, or mild or moderate alcohol use disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideParticipants 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 | Drug | Tirzepatide |
| PlaceboParticipants will receive placebo (saline) injections for Weeks 1-16 | Other | Placebo |
Primary outcome
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)
Biochemically verified abstinence from cigarette smoking
2 secondary outcomes
Cigarettes per day
Time frame: From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Weekly cigarette craving
Time frame: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keck School of Medicine, University of Southern California
Los Angeles, United States
University of Colorado Anschutz Medical Campus
Aurora, United States
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Smoking Cessation and Smoking Behaviors, run by University of Southern California at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.