Gabapentin Treatment of Cannabis Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
研究概览
简要总结
This is a clinical 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 study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.
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 from 18-65 years of age
- •Meets DSM IV criteria for current cannabis dependence
- •Seeking research-based outpatient treatment for cannabis dependence that involves daily medication
- •Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
- •At least a 2-year history of regular MJ use
排除标准
- •Abstinent from cannabis more than 2 days at the time of randomization
- •Active suicidal ideation
- •Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine
- •Significant medical disorders that will increase potential risk or interfere with study participation,
- •Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
- •Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence,
- •Inability to understand and/or comply with the provisions of the protocol and consent form
- •Treatment with an investigational drug during the previous month
- •Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients
- •Ongoing treatment with medications that may affect study outcomes
研究组 & 干预措施
Gabapentin 1200mg/day
1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
干预措施: Manual-guided behavioral counseling (Behavioral)
Gabapentin 1200mg/day
1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
干预措施: gabapentin 1200mg/day (Drug)
Placebo
1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
干预措施: Placebo (Drug)
Placebo
1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
干预措施: Manual-guided behavioral counseling (Behavioral)
结局指标
主要结局
Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
时间窗: 12 weeks
Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).
次要结局
未报告次要终点
研究者
Barbara J. Mason
PI
The Scripps Research Institute