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Tirzepatide for meth-bruksforstyrrelse

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

Tirzepatid for personer med komorbid fedme og metamfetaminbruksforstyrrelse

This is an open-label pilot study to evaluate the feasibility and preliminary efficacy of using tirzepatide when prescribed for its United States (US) Food and Drug Administration (FDA)-approved weight-related indication in individuals with comorbid methamphetamine use disorder.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study will enroll up to 45 individuals with moderate-to-severe methamphetamine use disorder who meet the FDA-approved weight-related indication for tirzepatide [as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 1) 30 kg/m2 or greater (obesity) or 2) 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease)].

Enrolled participants will receive weekly treatment with tirzepatide for a 32-week period that will be followed by 4-week-long observational follow-up. Participants of this study will be seen for weekly visits where they will complete clinical and/or laboratory assessments.

Studietype

Intervensjonell

Registrering (Faktiske)

35

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
    • Texas
      • Dallas, Texas, Forente stater, 75247
        • UT Southwestern Medical Center

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

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Be 18 to 65 years of age, inclusive.

  2. Be able to provide informed consent and ask relevant questions.

  3. Stated willingness to comply with all study procedures and availability for the duration of the study.

  4. Be willing to adhere to the study medication regimen

  5. Meet DSM-5 criteria for moderate or severe methamphetamine use disorder.

  6. Self-report methamphetamine use on 18 or more days in the 30-day period prior to written informed consent using the Timeline Followback (TLFB).

  7. Have an initial body mass index (BMI) at screening of:

    1. 30 kg/m2 or greater (obesity)
    2. 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease).

  8. If biologically female and is or becomes sexually active with a biological male, must agree to use acceptable methods of contraception and have urine pregnancy testing during participation in the study, unless unable to get pregnant

    a. Appropriate birth control methods include: i. Oral contraceptives, contraceptive patch, hormonal vaginal contraceptive ring (with restrictions related to dose change given the medication interactions between tirzepatide and oral contraceptives).

    ii. Barrier (diaphragm or condom) iii. Contraceptive implant iv. Medroxyprogesterone acetate injection v. Intra-uterine device vi. Complete abstinence from sexual intercourse vii. Surgical sterilization

  9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

  1. Current or recent use (within 3 months prior to consent) of other tirzepatide-containing products or any other GLP-1 receptor agonist
  2. Current or recent use (within 30 days) of sulfonylureas, other concomitantly administered insulin secretagogue, or insulin
  3. Current or recent use (within 3 months prior to consent) of other weight loss agents
  4. Weight loss surgery within 12 months prior to consent
  5. Current eating disorder per clinician evaluation
  6. Personal or family history of Medullary Thyroid Carcinoma
  7. History of Multiple Endocrine Neoplasia syndrome type 2
  8. Known serious hypersensitivity (e.g., anaphylaxis, angioedema) to tirzepatide or any of the excipients in tirzepatide
  9. History of angioedema or anaphylaxis with a GLP-1 receptor agonist
  10. Current Stage 3 or higher Chronic Kidney Disease, defined as eGFR <60 at Screening
  11. Current inadequately controlled diabetes, defined as HbA1c > 7.0 at Screening
  12. History of diabetic retinopathy
  13. Current pregnancy or lactation
  14. Treatment with another investigational drug or intervention within the past one month (30 days prior to consent)
  15. Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee.
  16. Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tirzepatide

Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 32-week period in accordance with FDA-prescribing label guidelines.
Legemiddel: Tirzepatide

Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 32-week period. Following the instructions of the FDA-approved prescribing label, participants or a licensed study clinician will administer the tirzepatide injection subcutaneously in either the abdomen, thigh, or upper arm once weekly for 32 weeks total. Following the instructions of the FDA-approved prescribing label, the dosing schedule will include a 4-week titration at a starting dosage of 2.5mg/week. After four weeks, dosage will be increased in 2.5mg increments. The recommended maintenance dosages per prescribing label are 5mg/week, 10mg/week, or 15mg/week injected subcutaneously. Maximum dosage (up to 15mg/week) will be optimized for each individual. We will use commercially available tirzepatide, primarily dispensed as ZEPBOUND® for this study, but in the event of medication shortage or other pharmacy-related issue, MOUNJARO® may be dispensed as an alternative.

Andre navn:
  • ZEPBOUND
  • MOUNJARO

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effect of tirzepatide on self-reported use of methamphetamine
Tidsramme: 36 weeks

Self-reported use of methamphetamine will be assessed through Timeline Followback. The Timeline Followback procedure will be used to elicit the participant's self-reported use of illicit substances, including but not limited to stimulants, and polysubstance use starting at the Screening Visit and continuing throughout study participation. During the Screening Visit, this form will be used to assess illicit use of substances for the 30-day period prior to written consent. During the study, TLFB will be administered to document the participant's self-reported use of illicit substances, nicotine, and tobacco for each visit since the previous TLFB assessment. Participant's drug of choice will be asked and determined by study coordinator and recorded along with the TLFB assessment.
36 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of using tirzepatide in individuals with Methamphetamine Use Disorder
Tidsramme: 4 weeks

Feasibility will be defined as the number of participants who receive a dose of tirzepatide of at least a 5mg/week for at least four weeks.
4 weeks
Changes in body mass index from baseline to the end of the 32-week treatment phase
Tidsramme: 32 weeks

Body mass index will be calculated using measurements of height and weight.
32 weeks
Changes in self-reported symptoms of anhedonia from baseline to the end of the 32-week treatment phase
Tidsramme: 32 weeks

Anhedonia, the inability to experience pleasure, will be assessed by the Snaith-Hamilton Pleasure Scale (SHAPS). The SHAPS questionnaire contains 14 items related to experiencing pleasure over the last several days. Participants are asked to rate their level of agreement or disagreement with each prompt. The scale has a scoring range of 0-14 where a higher point value indicates a higher level of anhedonia.
32 weeks
Changes in High-sensitivity C-reative protein (hs-CRP) levels from baseline to the end of the 32-week treatment phase
Tidsramme: 32 weeks

Clinical laboratory assessments for High-Sensitivity C-Reactive Protein (HsCRP) test will be performed to help determine eligibility at screening and monitor participant's overall health condition.
32 weeks
Changes in gastrointestinal symptom severity from baseline until the end of the 32-week treatment phase
Tidsramme: 32 weeks

Gastrointestinal symptom severity will be assessed by the Gastrointestinal Symptom Rating Scale (GSRS): a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS scale is graded on a seven-point Likert-type scale where a lower score (1) represents less symptom severity and highest score (7) represents greater symptom severity.
32 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

Etterforskere

  • Hovedetterforsker: Manish Jha, M.B.B.S., University of Texas Southwestern Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

3. februar 2025

Primær fullføring (Faktiske)

12. februar 2026

Studiet fullført (Faktiske)

12. februar 2026

Datoer for studieregistrering

Først innsendt

17. desember 2024

Først innsendt som oppfylte QC-kriteriene

17. desember 2024

Først lagt ut (Faktiske)

20. desember 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STU-2024-1221

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No individual participant data is planned to be shared with other researchers.

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. .

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