大麻使用障害の治療におけるチルゼパチド
大麻使用障害の治療におけるチルゼパチド：パイロット二重盲検プラセボ対照クロスオーバー試験
This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.
調査の概要
詳細な説明
This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder. Eligible participants will be scheduled in random order to receive either tirzepatide or placebo injection in double-blind fashion and cross-over design. Outcomes will be assessed at the following study visit. Washout period of at least 4 weeks will be required between tirzepatide or placebo injections. Primary outcome of interest is cue-induced craving to cannabis-related visual cues.
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：Mary R Shen, MD
- 電話番号：6177325752
- メール：mshen4@bwh.harvard.edu
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- English speaking adults aged 18 and above
- Diagnosed with DSM-5 cannabis use disorder, severe
Exclusion Criteria:
- Active psychosis, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
- Any current or lifetime diagnosis of eating disorders including anorexia, bulimia, binge eating or
- Comorbid substance use disorder
- BMI<21 kg/m2
- Current or lifetime diagnosis of Type 1 or Type 2 diabetes
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Use of any glucagon-like peptide -1 agonist medications in the prior 3 months
- Anticipating receipt of any glucagon-like peptide-1 agonist medications during the trial
- Current hypoglycemia as indicated by a blood sugar level of <71 mg/dL measured at baseline visit, as well as visits 2 and 4.
- Untreated cholelithiasis or gallbladder disease
- History of acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or congestive heart failure in the last 90 days
- Systolic blood pressure persistently above 160 mmHg or diastolic blood pressure persistently above 100 mmHg during screening
- History of inflammatory bowel disease, bariatric surgery, pancreatitis, diabetic gastroparesis, or non-arteritic anterior ischemic optic neuropathy
- Liver function test greater than 3 times upper normal limit
- Renal impairment as indicated by estimated glomerular filtration rate (eGFR) of <30
- History of hypersensitivity or allergy to tirzepatide
- Pregnant or breastfeeding
- Individuals taking glucagon-like peptide-1 agonists or other weight loss drugs.
- Anticipated to participate in a concurrent drug trial
- Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant
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：クロスオーバー割り当て
- 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
2.5mg subcutaneous injection once |
2.5mg subcutaneous injection once |
|
プラセボコンパレーター：placebo
matching placebo subcutaneous injection once |
Saline placebo subcutaneous injection once |
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 |
|---|---|---|
|
Cue-Induced Craving
時間枠：5 weeks
|
Craving scores will be assessed using a cue-reactivity paradigm in which participants are exposed to cannabis]-related cues. Scores range from 0 to 30, with higher scores indicating greater craving intensity. |
5 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serious adverse event
時間枠：5 weeks
|
Incidence of serious adverse events |
5 weeks
|
|
Cravings
時間枠：5 weeks
|
Cannabis craving scale using the 12-item questionnaire, each item scored on a 1-7 sale. Higher scores (either average or summed) indicates stronger cravings. |
5 weeks
|
|
Abstinence
時間枠：5 weeks
|
Percent days abstinent from cannabis |
5 weeks
|
|
Weight
時間枠：5 weeks
|
Weight |
5 weeks
|
|
Blood sugar
時間枠：5 weeks
|
Blood glucose |
5 weeks
|
|
Hemoglobin A1c
時間枠：5 weeks
|
Hemoglobin A1c |
5 weeks
|
|
Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8)
時間枠：5 weeks
|
Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 assesses depression severity over the past two weeks. Total scores range from 0 to 24, with higher scores indicating greater depression severity (worse outcome). Score interpretation: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-24 (severe depression). |
5 weeks
|
|
Anxiety severity as measured by the Generalized Anxiety Disorder-7 scale (GAD-7)
時間枠：5 weeks
|
The GAD-7 assesses anxiety symptom severity over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity (worse outcome). Score interpretation: 0-4 (minimal anxiety), 5-9 (mild), 10-14 (moderate), 15-21 (severe anxiety). |
5 weeks
|
|
Suicidality as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale)
時間枠：5 weeks
|
The C-SSRS assesses the presence and severity of suicidal ideation and behavior. Suicidal ideation severity scores range from 0 to 5 (0=no ideation, 1=wish to be dead, 2=non-specific active suicidal thoughts, 3=active suicidal ideation with methods, 4=suicidal intent, 5=suicidal intent with plan), with higher scores indicating greater severity (worse outcome). The scale also captures suicidal behavior as binary yes/no responses. |
5 weeks
|
協力者と研究者
捜査官
- 主任研究者：Joji Suzuki、Brigham and Women's Hospital
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2025P002984
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?
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。