A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Percentage of Negative Urine Cannabinoid Tests During Treatment
研究概览
简要总结
This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.
详细描述
This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.
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
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-21 years
- •Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment
排除标准
- •Allergy or intolerance to NAC
- •Pregnancy or lactation
- •Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation
- •Current enrollment in treatment for cannabis dependence
- •Current substance dependence, other than cannabis or nicotine
- •Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician
研究组 & 干预措施
N-Acetylcysteine
干预措施: N-Acetylcysteine (Drug)
N-Acetylcysteine
干预措施: Contingency Management (Behavioral)
Placebo
干预措施: placebo (Drug)
Placebo
干预措施: Contingency Management (Behavioral)
结局指标
主要结局
Percentage of Negative Urine Cannabinoid Tests During Treatment
时间窗: weekly during treatment, for 8 weeks
\[Total number of negative urine tests per Group divided by the total number of urine tests per Group\]\*100
次要结局
未报告次要终点
研究者
Kevin Gray, MD
Associate Professor
Medical University of South Carolina