Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
研究概览
简要总结
The primary aim of the supplemental study is to provide POC testing of aprepitant as a treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in the parent grant will likewise be applied to the supplemental project to test for effects of aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The primary hypothesis is that subjects treated with aprepitant will have significantly less alcohol and marijuana use than subjects treated with placebo.
详细描述
Consistent with the scope and methods of the parent grant, this was a randomized, double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment for concurrent alcohol and cannabis dependence. All participants received weekly protocol-specific counseling. Research assessments occurred weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females from 18-70 years of age
- •Meets DSM IV criteria for current alcohol and cannabis dependence
- •Seeking research-based outpatient treatment for alcohol and cannabis dependence that involves daily oral medication
- •Negative BAC and a CIWA score < 9 at randomization
排除标准
- •Significant medical disorders or use of medications that will increase potential risk or influence study outcomes
- •Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use an effective, non hormonal method of birth control during the study and for up to 4 weeks after study termination• Treatment with an investigational drug during the previous month
- •Prior treatment with NK1 antagonists
- •Participants for whom treatment is being mandated by a legal authority• Inability to understand and/or comply with the provisions of the protocol and consent form
研究组 & 干预措施
Experimental: aprepitant 125 mg/day
125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
干预措施: aprepitant (Drug)
Experimental: aprepitant 125 mg/day
125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
干预措施: Manual-guided behavioral counseling (Behavioral)
Placebo 125mg/d
Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
干预措施: Placebo (Drug)
Placebo 125mg/d
Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
干预措施: Manual-guided behavioral counseling (Behavioral)
结局指标
主要结局
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
时间窗: Week 0 and Week 8
Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).
Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
时间窗: Week 0 and Week 8
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.
次要结局
未报告次要终点
研究者
Barbara J. Mason
Principal Investigator
The Scripps Research Institute