Tirzepatide for the Treatment of Cannabis Use Disorder: A Pilot Double-blind, Placebo-controlled, Crossover Trial
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 6
- 主要终点
- Cue-Induced Craving
概览
简要总结
This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind placebo-controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking adults aged 18 and above
- •Diagnosed with DSM-5 cannabis use disorder, severe
排除标准
- •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
- •Untreated cholelithiasis or gallbladder disease
研究组 & 干预措施
tirzepatide
2.5mg subcutaneous injection once
干预措施: Tirzepatide (Drug)
placebo
matching placebo subcutaneous injection once
干预措施: Placebo (Drug)
结局指标
主要结局
Cue-Induced Craving
时间窗: 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.
次要结局
- Cravings(5 weeks)
- Abstinence(5 weeks)
- Weight(5 weeks)
- Blood sugar(5 weeks)
- Hemoglobin A1c(5 weeks)
- Serious adverse event(5 weeks)
- Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8)(5 weeks)
- Anxiety severity as measured by the Generalized Anxiety Disorder-7 scale (GAD-7)(5 weeks)
- Suicidality as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale)(5 weeks)
研究者
Joji Suzuki, MD
Principal Investigator, Division of Addiction Treatment and Prevention, AMC Psychiatry Mass General Brigham
Brigham and Women's Hospital