The Role of Sleep in the Treatment of Cannabis Use Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing
研究概览
简要总结
The number of people seeking treatment for marijuana-related problems is on the rise, yet there is no currently accepted medication proven to help them quit. Frequent marijuana users have reported that they have trouble sleeping when they try to quit, and that the loss of sleep can lead to relapse. This research is designed to measure the severity of sleep problems in people as they are trying to quit heavy use of marijuana, and to investigate whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to stop using marijuana.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-55 years.
- •Recent problematic use of cannabis
- •Cannabis use impacts sleep
排除标准
- •Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder
- •Moderate sleep apnea or periodic limb movement disorder
- •Pregnant, breast feeding, or planning to become pregnant within the next 3 months
- •Current condition associated with severe cognitive/social impairment
- •Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem
- •Current use of drugs that affect metabolism via cytochrome P450 or current illness resulting in severe hepatic impairment
- •Current use of hypnotic medications
研究组 & 干预措施
Zolpidem
Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
干预措施: Zolpidem extended-release (Drug)
Zolpidem
Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
干预措施: MET/CBT (Behavioral)
Placebo
Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
干预措施: MET/CBT (Behavioral)
结局指标
主要结局
Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing
时间窗: Week 12
Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH \<50ng/mL via EIA.
Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed
时间窗: Week 1 of treatment
Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.
次要结局
未报告次要终点