Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Tirzepatide for Treatment of Cannabis Use Disorder (CUD)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The purpose of this randomized, double-blind, placebo-controlled, multi-site clinical trial is to evaluate the safety and efficacy of tirzepatide in a sample of 100 patients diagnosed with moderate or severe CUD by DSM-5 criteria.
详细描述
This is a double-blind, placebo-controlled, randomized clinical trial. 100 individuals with moderate to severe cannabis use disorder (CUD) will be randomized in a 1:1 ratio to receive either (1) weekly subcutaneous injections of tirzepatide or (2) weekly subcutaneous injections of matching placebo for 24 weeks. Tirzepatide will be initiated at 2.5 mg for 4 weeks (4 injections) and increased in 2.5 mg increments every 4 weeks as tolerated, up to a maximum dose of 15 mg.
The Primary Objective is to determine the maximum tolerated dose (MTD) of tirzepatide in individuals with CUD and to evaluate its efficacy in reducing cannabis use.
The primary Hypothesis is that tirzepatide will be well tolerated within the FDA-recommended dose range and compared with placebo, it will result in a significantly greater proportion of cannabis abstinent days as measured by the timeline follow-back (TLFB).
Secondary Objectives are to evaluate the effects of tirzepatide, relative to placebo, on (1) CUD severity based on DSM-5 criteria; (2) percentage of cannabis-negative weekly urine drug screens collected during the treatment period; (3) cannabis craving; (4) cannabis withdrawal severity; (5) retention in treatment; and (6) quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 70 years of age
- •Meets DSM-5 criteria for moderate or severe CUD
- •Interested in treatment for cannabis use disorder
- •Able to understand the study procedures and written informed consent in English
- •Willing to comply with all study procedures and medication instructions
- •If female, is not pregnant, and agrees to use acceptable birth control methods
排除标准
- •Body Mass Index (BMI) ≤ 23 kg/m²
- •Presence of a medical or psychiatric disorder that contraindicates participation in the study
- •Substance use disorder other than tobacco or mild alcohol-use disorder
- •Known allergy or hypersensitivity to Tirzepatide, any GLP-1 or GIP receptor agonist, or any of the excipients in the product
- •Current or recent (past 30 days) use of GLP-1 receptor agonists or other weight-loss drug
- •Current or recent (past 6 months) enrollment in substance use disorder treatment
- •Current or planned pregnancy and breastfeeding
- •Living or medical situation that would interfere with adherence to the study protocol
研究组 & 干预措施
Active Treatment
干预措施: Tirzepatide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 24 weeks (Treatment Phase)
The maximum tolerated dose defined as the median dose within the FDA-recommended range, at which dose increase is not recommended (based on standardized and health care provider assessments).
Days of Abstinence
时间窗: 24 weeks (Treatment Phase)
Number of days per week with no cannabis use, as assessed by Timeline Follow Back (TLFB).
次要结局
- 1. Cannabis Withdrawal(24 weeks (Treatment Phase))
- Severity of Cannabis Use Disorder (CUD)(24 weeks (Treatment Phase))
- Negative Urine Drug Screens (UDS)(24 weeks (Treatment Phase))
- Cannabis Craving(24 weeks (Treatment Phase))
- Retention in Treatment(Week 24 (End of Treatment Phase))
- Quality of Life(24 weeks (Treatment Phase))