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Multi-Site Trial of Tirzepatide for Smoking Cessation

15 juli 2026 bijgewerkt door: University of Southern California

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

300

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90033
        • Werving
        • Keck School of Medicine, University of Southern California
        • Contact:
        • Hoofdonderzoeker:
          • Christian Hendershot, Ph.D.
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • Werving
        • University of Colorado Anschutz Medical Campus
        • Hoofdonderzoeker:
          • Joseph Schacht, PhD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06510
        • Werving
        • Yale University School Of Medicine
        • Contact:
        • Hoofdonderzoeker:
          • Sherry McKee, PhD
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
        • Werving
        • University of Chicago Pritzker School of Medicine
        • Contact:
        • Hoofdonderzoeker:
          • Andrea King, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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 baseline
  8. Use of an acceptable birth control method for female participants*
  9. Ability to read and communicate in English

Exclusion Criteria:

  1. BMI < 25 kg/m2 at screening
  2. History of diabetes, diabetes-attributable medical conditions, or HbA1c ≥6.5% at baseline
  3. Recent (past 90 days) active suicidal ideation or lifetime history of suicide attempt
  4. 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
  5. 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.
  6. 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.
  7. Past 30-day initiation of psychiatric medications (e.g., SSRIs) or changes to medication dose
  8. Treatment with tirzepatide or another GLP-1RA medication in the prior 6 months
  9. Current (past month) treatment with other weight loss, diabetes, or smoking cessation medications (varenicline or bupropion; excluding nicotine replacement products)
  10. Severe GI disease (e.g., gastroparesis, ulcerative colitis).
  11. History of gastric bypass surgery or other surgeries of the stomach
  12. 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
  13. History of chronic pancreatitis or acute pancreatitis in the last 6 months
  14. Currently nursing, pregnant, or anticipating pregnancy
  15. History of diabetic retinopathy, proliferative retinopathy, or maculopathy
  16. Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (>5x upper limit of normal range)
  17. History of malignant neoplasms in the last 5 years, except non-melanoma skin cancer
  18. Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule)
  19. Currently enrolled in another clinical study involving an investigational product
  20. 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
  21. Planned surgical procedures requiring anesthesia during the planned study medication period
  22. Personal or family history of medullary thyroid cancer
  23. Personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN 2)
  24. 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
  25. Any health condition or treatment/medication that would preclude use of tirzepatide or NRT, in the opinion of the site physicians including thyroid enlargement.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Ander: Placebo
Participants will receive placebo (saline) injections for Weeks 1-16
Experimenteel: Tirzepatide
Geneesmiddel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
7-day point prevalence abstinence
Tijdsspanne: 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
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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cigarettes per day
Tijdsspanne: From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Weekly cigarette craving
Tijdsspanne: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
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.
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Current cigarette craving
Tijdsspanne: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Current cigarette craving will be measured with the Questionnaire on Smoking Urges-Brief, a 10-item scale with items, each scored on a 1-7 scale. Items are summed to generate a total score.
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Smoking withdrawal
Tijdsspanne: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Withdrawal symptoms are measured with the Wisconsin Smoking Withdrawal Scale (WSWS). The WSWS includes 28 items, each rated on a scale of 0-4. Items are summed to calculate the scale scores.
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Body weight
Tijdsspanne: Treatment week 1 through treatment week 16 (final assessment at Week 17 visit)
Treatment week 1 through treatment week 16 (final assessment at Week 17 visit)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Southern California

Medewerkers

National Institute on Drug Abuse (NIDA)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 juni 2026

Primaire voltooiing (Geschat)

1 maart 2028

Studie voltooiing (Geschat)

1 september 2028

Studieregistratiedata

Eerst ingediend

11 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

15 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HS-25-00642
  • U01DA064384 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

IPD-tijdsbestek voor delen

The protocol and SAP will be made available at or before the completion of the study. Requests for IPD will be reviewed following publication of primary study results.

IPD-toegangscriteria voor delen

Data will be made available to researchers whose proposed purpose for accessing the data has been approved, and provided a data sharing agreement is in place.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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