Gabapentin for Cannabis Withdrawal and Use
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12
研究概览
简要总结
This is a study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
详细描述
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. Counseling and research assessments occur weekly throughout the 12-week treatment phase.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 18-65 with cannabis dependence
- •Meets DSM-IV-TR criteria for Cannabis Dependence
- •Smoked marijuana at least once a week in the 90 days prior to study participation
- •Willing to attend 12 weekly study visits and 1 follow-up visit
排除标准
- •Currently meets DSM-IV-TR criteria for dependence on illicit substances other than cannabis
- •Significant medical disorders that will increase potential risk or interfere with study participation
- •Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
- •Treatment with an investigational drug in the last month
研究组 & 干预措施
Gabapentin
1200 mg/daily of Gabapentin
干预措施: Gabapentin (Drug)
Placebo
1200mg/d of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12
时间窗: Week 0 and Week 12
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.
次要结局
- Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12(Week 0 and Week 12)
- Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12(Week 0 and Week 12)
- Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12(Week 0 and Week 12)
- Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12(Week 0 and Week 12)
- Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4(Week 0 and Week 4)
- Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12(Week 0 and Week 12)
研究者
Barbara J. Mason
Professor
The Scripps Research Institute