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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Elizabeth Dedrick, BS
- 電話番号：469-602-2356
- メール：elizabeth.dedrick@utsouthwestern.edu
研究連絡先のバックアップ
- 名前：Shavonna Williams
- 電話番号：469-602-1926
- メール：shavonna.williams@utsouthwestern.edu
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90032
- University of Southern California (USC)
-
コンタクト：
- Jimena Estrada
- 電話番号：386-846-6139
- メール：jimenaes@usc.edu
-
San Francisco、California、アメリカ、94102
- Center of Substance Use and Health
-
コンタクト：
- Xochitl Luna Marti
- 電話番号：628-217-6235
- メール：xochitl.lunamarti@sfdph.org
-
コンタクト：
- Samantha Serrano
- メール：samantha.serrano@sfdph.org
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-
Oklahoma
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Tulsa、Oklahoma、アメリカ、74136
- Oklahoma State University (OSU) Center for Health Services
-
コンタクト：
- Katie Thompson, BS
- 電話番号：603-978-2208
- メール：kthompson@okstate.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
他の名前：
|
|
プラセボコンパレーター：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment response
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tolerability - stopping of treatment
時間枠：26 weeks
|
Proportion of participants discontinuing or stopping treatment before Week 26 visit.
|
26 weeks
|
|
Current craving for methamphetamine
時間枠：27 weeks
|
Severity score (range: 0-70) on stimulant craving questionnaire, higher score reflects more severe craving.
|
27 weeks
|
|
Early remission
時間枠：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
時間枠：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
時間枠：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
時間枠：27 weeks
|
Visual analog scale (VAS) for drug craving for methamphetamine, rated on 0-100, higher score indicates more severe craving
|
27 weeks
|
協力者と研究者
捜査官
- 主任研究者：Manish Jha, MBBS、University of Texas Southwestern Medical Center
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STU20260467
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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