Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder (T-STEM)
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 methamphetamine use disorder (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:
- completing self-assessments
- undergo brief physical and review of medical and psychiatric history
- provide urine and blood samples
- medical management sessions
- weekly subcutaneous study medication injections
Studieoversikt
Status
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 urine drug screen [UDS] negative in weeks 23-26), and early remission (no longer meeting Diagnostic and Statistical Manual 5th edition [DSM-5] criteria at week 26). Secondary/exploratory aims include assessing reductions in methamphetamine craving and cravings for other substances.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Elizabeth Dedrick, BS
- Telefonnummer: 469-602-2356
- E-post: elizabeth.dedrick@utsouthwestern.edu
Studer Kontakt Backup
- Navn: Shavonna Williams
- Telefonnummer: 469-602-1926
- E-post: shavonna.williams@utsouthwestern.edu
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90032
- Har ikke rekruttert ennå
- University of Southern California (USC)
-
Ta kontakt med:
- Jimena Estrada
- Telefonnummer: 213-962-0698
- E-post: jimenaes@usc.edu
-
Hovedetterforsker:
- Christian Hendershot, PhD
-
San Francisco, California, Forente stater, 94102
- Har ikke rekruttert ennå
- Center of Substance Use and Health
-
Ta kontakt med:
- Xochitl Luna Marti
- Telefonnummer: 628-217-6235
- E-post: xochitl.lunamarti@sfdph.org
-
Ta kontakt med:
- Samantha Serrano
- E-post: samantha.serrano@sfdph.org
-
Hovedetterforsker:
- Phillip Coffin, MD
-
-
Oklahoma
-
Tulsa, Oklahoma, Forente stater, 74136
- Har ikke rekruttert ennå
- Oklahoma State University (OSU) Center for Health Services
-
Ta kontakt med:
- Katie Thompson, BS
- Telefonnummer: 603-978-2208
- E-post: kthompson@okstate.edu
-
Hovedetterforsker:
- Kyle Simmons, PhD
-
-
Texas
-
Dallas, Texas, Forente stater, 75247
- Rekruttering
- UT Southwestern Medical Center
-
Ta kontakt med:
- Teresa Slettebo, BA
- Telefonnummer: 214-998-5649
- E-post: teresa.slettebo@utsouthwestern.edu
-
Hovedetterforsker:
- Manish Jha, MBBS
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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. |
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:
|
|
Placebo komparator: Placebo (Saline)
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period. |
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
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Manish Jha, MBBS, University of Texas Southwestern Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Kjemisk-induserte lidelser
- Stoffrelaterte lidelser
- Aminosyrer, peptider og proteiner
- Proteiner
- Uorganiske kjemikalier
- Klorforbindelser
- Glukagonlignende peptid-1 reseptor
- Glukagonlignende peptidreseptorer
- Reseptorer, G-protein-koblet
- Reseptorer, celleoverflate
- Membranproteiner
- Reseptorer, gastrointestinal hormon
- Reseptorer, peptid
- Natriumforbindelser
- Klorider
- Saltsyre
- Tirzepatid
- Natriumklorid
Andre studie-ID-numre
- STU20260467
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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
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