A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8)
研究概览
简要总结
This is a 8-week randomized, placebo-controlled trial testing the effects of N-acetylcysteine (NAC), on a platform of weekly evidence-based brief alcohol intervention for 120 adolescents with alcohol use disorder (AUD). The primary efficacy endpoint is reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.
详细描述
Adolescence is a critical developmental stage involving marked elevation in alcohol initiation, progression to AUD, and development of significant, lasting adverse outcomes from use. Effective treatments must be developed for AUD in this especially vulnerable age range. The identification of a well-tolerated, effective pharmacological treatment would represent a significant advance and could yield tremendous public health impact. The proposed trial will provide critical data to evaluate NAC as a highly promising pharmacotherapy for adolescent AUD, and regardless of NAC versus placebo outcomes will provide key methodological guidance for future randomized controlled trials of pharmacotherapies for adolescent AUD. Randomized participants will be provided and instructed to take their assigned medication at 1200 mg twice daily, in approximately twelve-hour intervals.
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)
盲法说明
Double-blind placebo-controlled pharmacotherapy trial
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 13-25
- •Must be able to understand the study and provide written informed consent (for participants under 18 years old, a parent/legal guardian must be able to provide consent and the participant must be able to provide assent).
- •Current moderate to heavy drinker by established adolescent criteria
- •Meet criteria for alcohol use disorder
- •Females must agree to use appropriate birth control methods during study participation: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring
排除标准
- •Score >10 on the Clinical Institute Withdrawal Assessment for Alcohol
- •Allergy or intolerance to N-acetylcysteine
- •Females who are pregnant, contemplating pregnancy or lactating over the next 6 months
- •Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)
- •Current enrollment in treatment for alcohol use disorder or expectation of other treatment during protocol participation
- •Any other medical or psychiatric condition or other significant concern that in the Investigator's opinion would impact participant safety or compliance with study instructions, or potentially cofound the interpretation of findings
研究组 & 干预措施
N-acetylcysteine
N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally
干预措施: N-acetylcysteine (Drug)
Placebo
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8)
时间窗: Final 4 weeks of treatment
Alcohol use (total standard drinks) during the final four weeks of treatment (Weeks 5-8), compared between NAC and placebo groups.
次要结局
未报告次要终点
研究者
Kevin Gray
Professor of Psychiatry and Behvavioral Sciences
Medical University of South Carolina