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Multi-Site Trial of Tirzepatide for Smoking Cessation

15. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90033
        • Rekruttering
        • Keck School of Medicine, University of Southern California
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christian Hendershot, Ph.D.
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Rekruttering
        • University of Colorado Anschutz Medical Campus
        • Hovedetterforsker:
          • Joseph Schacht, PhD
        • Ta kontakt med:
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06510
        • Rekruttering
        • Yale University School Of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sherry McKee, PhD
    • Illinois
      • Chicago, Illinois, Forente stater, 60637
        • Rekruttering
        • University of Chicago Pritzker School of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Andrea King, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Annen: Placebo
Participants will receive placebo (saline) injections for Weeks 1-16
Eksperimentell: Tirzepatid
Legemiddel: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
7-day point prevalence abstinence
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cigarettes per day
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Current cigarette craving
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Southern California

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2026

Primær fullføring (Antatt)

1. mars 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HS-25-00642
  • U01DA064384 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere