Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder (T-STEM)

11. september 2026 oppdatert av: Manish Jha, University of Texas Southwestern Medical Center

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the tolerability, safety, and preliminary efficacy of tirzepatide for the treatment of individuals with moderate or severe MtUD. The central hypothesis of the proposed research is that tirzepatide is a safe and potentially efficacious treatment of MtUD.

Participants will undergo study procedures over 32 weeks, including:

  1. completing self-assessments
  2. undergo brief physical and review of medical and psychiatric history
  3. provide urine and blood samples
  4. medical management sessions
  5. weekly subcutaneous study medication injections

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Methamphetamine use disorder (MtUD) affects over 1.5 million U.S. adults annually and has no FDA-approved treatments. Preclinical studies and observational data suggest that glucagon-like peptide-1 receptor agonists (GLP-1RAs) may reduce stimulant use. Tirzepatide, a dual GLP-1/glucose-dependent insulinotropic peptide (GIP) receptor agonist approved for type 2 diabetes and weight management, has not been evaluated for MtUD in an adequately-powered randomized controlled trial. This Phase 2 double-blind, randomized controlled trial will enroll 228 adults with moderate or severe MtUD to receive weekly subcutaneous tirzepatide (2.5 mg/week titrated to 15 mg/week or maximally tolerated dose) or placebo for 26 weeks, followed by 6 weeks of follow-up. Safety will be monitored throughout.

The study aims are to: (1) assess tolerability (treatment discontinuation) and safety (serious adverse events) of tirzepatide; and (2) evaluate preliminary efficacy, including reduction in methamphetamine use (Timeline Follow-back), treatment response (≥6 of 8 UDS negative in weeks 23-26), and early remission (no longer meeting DSM-5 criteria at week 26). Secondary/exploratory aims include assessing reductions in methamphetamine craving and cravings for other substances.

Studietype

Intervensjonell

Registrering (Antatt)

228

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90032
        • University of Southern California (USC)
        • Ta kontakt med:
      • San Francisco, California, Forente stater, 94102
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74136
        • Oklahoma State University (OSU) Center for Health Services
        • Ta kontakt med:

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:

  • be aged 18 to 65 years;
  • have moderate or severe methamphetamine use disorder;
  • have active pattern of methamphetamine use;
  • be interested in reducing or stopping methamphetamine use;
  • be able and willing to provide informed consent, comply with all study procedures, and adhere to weekly study medication injections;
  • be overweight or obese (body mass index ≥25 kg/m²); and
  • (only for biological females) agree to use acceptable contraception and undergo urine pregnancy testing unless unable to become pregnant

Exclusion Criteria:

  • report using any glucagon like peptide 1 receptor agonists (GLP-1RA, including tirzepatide), sulfonylureas, or insulin in the past 90 days;
  • have a current eating disorder or severe alcohol or substance use disorder;
  • have personal or family history of medullary thyroid carcinoma, history of multiple endocrine neoplasia type 2, or hypersensitivity, angioedema, or anaphylaxis to GLP-1RAs or tirzepatide;
  • have Stage 3 or higher chronic kidney disease, inadequately controlled diabetes, history of diabetic retinopathy, any unstable or serious medical or psychiatric condition, or any other reason or clinical condition that may either interfere with study participation or make the study participation unsafe (per investigator judgement);
  • are currently pregnant, breastfeeding, or planning pregnancy;
  • have received an investigational drug within 30 days of informed consent;
  • require psychiatric hospitalization;
  • have recent suicidal or current homicidal ideation;
  • are incarcerated or in court-mandated residential placement;
  • have unsafe use of alcohol, benzodiazepines, sedative/hypnotics, or other substances; or
  • have use of concurrent medications that may pose safety risks or interfere with study procedures.

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tirzepatide
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period.
Legemiddel: Tirzepatide
Eligible participants who are randomized to treatment group will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period. Tirzepatide will start at 2.5 mg/week with planned dose increases every four weeks in 2.5 mg/week increments up to a maximum of 15 mg/week (or the maximally tolerated dose).
Andre navn:
  • Mounjaro
  • Zepbound
Placebo komparator: Placebo (Saline)
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period.
Legemiddel: Placebo (saline)
Eligible participants who are randomized to placebo group will receive once-weekly subcutaneous injections of saline for a 26-week period.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Treatment response
Tidsramme: 26 weeks
Proportion of participants who attain treatment response (≥6 of 8 urine drug screens (UDS) negative for methamphetamine in Weeks 23 to 26).
26 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tolerability - stopping of treatment
Tidsramme: 26 weeks
Proportion of participants discontinuing or stopping treatment before Week 26 visit.
26 weeks
Current craving for methamphetamine
Tidsramme: 27 weeks
Severity score (range: 0-70) on stimulant craving questionnaire, higher score reflects more severe craving.
27 weeks
Early remission
Tidsramme: 27 weeks
Proportion of participants no longer meeting DSM-5 criteria for at least 3 months (criterion for craving permitted) at the Week 27 visit.
27 weeks
Safety - occurrence of serious adverse event
Tidsramme: 26 weeks
Proportion of participants with the occurrence of serious adverse event any time on or after Week 1 visit that is deemed to be related to study drug.
26 weeks
Reduction in self-reported use of methamphetamine
Tidsramme: 26 weeks
From first day of Week 1 to last day of Week 26, participant's use of methamphetamine will be recorded as a binary variable (yes/no), and compared across the two treatment arms.
26 weeks
Worst past-week craving for methamphetamine
Tidsramme: 27 weeks
Visual analog scale (VAS) for drug craving for methamphetamine, rated on 0-100, higher score indicates more severe craving
27 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

University of Texas Southwestern Medical Center

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)

Etterforskere

  • Hovedetterforsker: Manish Jha, MBBS, University of Texas Southwestern Medical Center

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 (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. juli 2031

Studiet fullført (Antatt)

1. august 2031

Datoer for studieregistrering

Først innsendt

11. september 2026

Først innsendt som oppfylte QC-kriteriene

11. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STU20260467

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

IPD data will be shared based on NIH Policy of Data Management and Sharing.

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

produkt produsert i og eksportert fra USA

Ja

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