An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period
研究概览
简要总结
The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.
详细描述
This project involves investigation of oral N-acetylcysteine (NAC) as a potential pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence continues to be a major problem among adolescents in the United States. To date, psychosocial interventions have produced only small to modest effect sizes in controlled trials, and minimal work has been done to investigate the potential role for pharmacotherapy for cannabis dependence. Translating preclinical research suggesting a role for NAC in cocaine dependent individuals, our research group has developed preliminary evidence of decreased cocaine use and cue reactivity in humans taking NAC. Preclinical research has additionally demonstrated significant parallels in glutamatergic dysfunction in the nucleus accumbens (the proposed target of NAC treatment) between habitual cocaine and marijuana users. NAC is an inexpensive, long-available agent with a favorable tolerability profile in adults and children. However, it has not yet been studied in cannabis dependent adolescents. Hence, we are undertaking an open-label pilot trial of NAC in adolescents with cannabis dependence.
The primary specific aims of the proposed project are:
- To assess the feasibility of conducting a trial of NAC in cannabis dependent adolescents.
- To assess the safety and tolerability of NAC in cannabis dependent adolescents
The secondary specific aim of the proposed project is: 3. To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
Primary hypotheses
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 12 - 20 years old.
- •Participants must be regular smokers of marijuana (on average smoke at least 3 times per week for at least one year) and meet DSM-IV Criteria for cannabis dependence, with desire to cut down on marijuana use.
- •Participants must understand all oral and written informed consent and give such consent prior to on-site screening.
- •Participants must agree to refrain from marijuana use for 24 hours prior to each cue reactivity session (Visits 2 and 4).
- •Participants must have a person that can be contacted in case of emergency.
- •Participants must have had stable residence for the past 30 days.
- •Post-menarchal female participants must agree to use birth control to avoid pregnancy.
排除标准
- •Allergy or intolerance to N-Acetylcysteine (NAC).
- •Pregnancy or lactation.
- •History of seizures.
- •Current or past history of asthma and/or the occasional or daily use of albuterol or other beta-agonist inhalers.
- •Current use of medications that might affect heart rate or skin conductance.
- •Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study.
- •History of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction,), stroke, seizure, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, metabolic, or other disorders that may place the participant at increased risk per the judgment of the study physician.
研究组 & 干预措施
N-Acetylcysteine
All participants will receive N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues will be investigated.
干预措施: N-Acetylcysteine (Drug)
结局指标
主要结局
Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period
时间窗: one year
Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study.
次要结局
未报告次要终点
研究者
Kevin Gray, MD
Professor of Psychiatry and Behavioral Sciences
Medical University of South Carolina