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 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Elizabeth Dedrick, BS
- 전화번호: 469-602-2356
- 이메일: elizabeth.dedrick@utsouthwestern.edu
연구 연락처 백업
- 이름: Shavonna Williams
- 전화번호: 469-602-1926
- 이메일: shavonna.williams@utsouthwestern.edu
연구 장소
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California
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Los Angeles, California, 미국, 90032
- University of Southern California (USC)
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연락하다:
- Jimena Estrada
- 전화번호: 386-846-6139
- 이메일: jimenaes@usc.edu
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San Francisco, California, 미국, 94102
- Center of Substance Use and Health
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연락하다:
- Xochitl Luna Marti
- 전화번호: 628-217-6235
- 이메일: xochitl.lunamarti@sfdph.org
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연락하다:
- Samantha Serrano
- 이메일: samantha.serrano@sfdph.org
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Oklahoma
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Tulsa, Oklahoma, 미국, 74136
- Oklahoma State University (OSU) Center for Health Services
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연락하다:
- Katie Thompson, BS
- 전화번호: 603-978-2208
- 이메일: kthompson@okstate.edu
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Tirzepatide
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period.
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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).
다른 이름들:
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위약 비교기: Placebo (Saline)
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period.
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Eligible participants who are randomized to placebo group will receive once-weekly subcutaneous injections of saline for a 26-week period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment response
기간: 26 weeks
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Proportion of participants who attain treatment response (≥6 of 8 urine drug screens (UDS) negative for methamphetamine in Weeks 23 to 26).
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26 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tolerability - stopping of treatment
기간: 26 weeks
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Proportion of participants discontinuing or stopping treatment before Week 26 visit.
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26 weeks
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Current craving for methamphetamine
기간: 27 weeks
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Severity score (range: 0-70) on stimulant craving questionnaire, higher score reflects more severe craving.
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27 weeks
|
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Early remission
기간: 27 weeks
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Proportion of participants no longer meeting DSM-5 criteria for at least 3 months (criterion for craving permitted) at the Week 27 visit.
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27 weeks
|
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Safety - occurrence of serious adverse event
기간: 26 weeks
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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.
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26 weeks
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Reduction in self-reported use of methamphetamine
기간: 26 weeks
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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.
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26 weeks
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Worst past-week craving for methamphetamine
기간: 27 weeks
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Visual analog scale (VAS) for drug craving for methamphetamine, rated on 0-100, higher score indicates more severe craving
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27 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Manish Jha, MBBS, University of Texas Southwestern Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STU20260467
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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