A Phase 2B, 8-week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults With DSM5 Current Cannabis Use Disorder (CUD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 4
- 主要终点
- Time Line Follow Back (TLFB) for Cannabis Use
研究概览
简要总结
A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder (CUD)
详细描述
The efficacy, safety and tolerability of the FAAH Inhibitor PF-0447845 in reducing cannabis use will be studied in a 4-site randomized, double-blind, placebo-controlled, parallel-group, outpatient clinical trial comparing PF-04457845 (4mg) and placebo in DSM-5 CUD individuals. Participants will be randomized in a 1:1 ratio to either PF-04457845 or placebo using random block sizes of 2 and 4, stratified by site and degree of cannabis use. Participants will receive motivational interviewing for 2 weeks before being randomized to receive study medication to make a quit attempt within the first week of treatment. Participants will receive active or placebo PF-04457845 for 8 weeks during which time they will be evaluated weekly in face to face visits. In addition, daily assessment of adherence to study medication and cannabinoid use will be conducted daily by cellphone. Measures of cannabinoid exposure (self-reported and urine toxicology), and problems related to the use of cannabis, will be assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-60 years, inclusive.
- •Male or Female.
- •Individuals with DSM-V criteria for Cannabis Use Disorder .
- •Positive for urinary THC-COOH at both screening visits.
- •Must express a willingness at screening to set a date within the first week of randomization to attempt to quit using cannabis.
排除标准
- •Clinically significant unstable medical disorders (as determined by the site investigator).
- •Laboratory tests with clinically significant abnormalities (as determined by the site investigator)
- •Pregnancy by history and or laboratory confirmation (serum HCG).
- •Physiological dependence on another substance.
研究组 & 干预措施
PF-04457845
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
干预措施: PF 04457845 (Drug)
Placebo
Subjects will be randomized to placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Time Line Follow Back (TLFB) for Cannabis Use
时间窗: Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then weekly average daily use over 8 weeks.
Change in the average number of times per day of self-reported cannabis consumption measured by the Timeline Follow Back approach for Cannabis Use in which participants quantify and report their frequency of cannabis use prior to study participation and throughout the study. Differences between groups in the change from baseline use (2 weeks prior to randomization) in the average number of times per day of self-reported consumption of cannabis or a cannabis containing product in the last 4 weeks of treatment captured using the daily TLFB data collected during CAROMA calls.
Urinary Levels of THC-COOH (ng/ml)
时间窗: baseline, week 1, week 3, week 5, week 7, and week 9 visits
Assay of the levels of the principal metabolite of THC (THC-COOH) in urine samples at baseline and bi-weekly over 8 weeks.
次要结局
未报告次要终点
研究者
Deepak C. D'Souza
Professor of Psychiatry
Yale University