Achieving Cannabis Cessation: Evaluating N-Acetylcysteine Treatment (ACCENT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 6
- 主要终点
- The Odds of Negative Urine Cannabinoid Tests During Treatment.
研究概览
简要总结
The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200 mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).
详细描述
The primary objective of this Phase 3 study is to evaluate the impact of NAC 1200 mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50). After assessment and inclusion into the study, participants will be randomized to receive a 12-week course of NAC 1200 mg or matched placebo twice daily. All participants will concurrently participate in a twice-weekly contingency management (CM) intervention. Medication management will be conducted weekly throughout treatment by the medical clinician. Urine cannabinoid testing will occur at all visits, and will be used as the primary determinant of cannabis use. Participants will return approximately four weeks after treatment conclusion for evaluation of adverse events with medication discontinuation and sustained treatment effects.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50 years
- •Must be able to understand the study and provide written informed consent
- •Must meet current DSM-IV criteria for cannabis dependence in the last 30 days
- •Must express interest in treatment for cannabis dependence
- •Must submit a positive urine cannabinoid test during screening
- •Women of child bearing potential 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
- •Allergy or intolerance to N-Acetylcysteine
- •Women who are pregnant or lactating
- •Current use of NAC or any supplement containing N-Acetylcysteine (must agree not to take any such supplement throughout study participation)
- •Use of carbamazepine or nitroglycerin within 14 days of randomization
- •Current enrollment in treatment for cannabis dependence
- •Any use of synthetic cannabinoids (such as K2/Spice) in the 30 days prior to screening or during the period between screening and randomization
- •Current substance dependence, other than cannabis or nicotine
- •Urine drug screen positive for any drug of abuse other than cannabis or amphetamines at the randomization visit (Only participants who have a valid prescription for amphetamines (e.g., for ADHD) may be included)
- •Urine drug screen positive for amphetamines at the randomization visit without having a valid prescription for it
- •Maintenance treatment with buprenorphine or methadone
- •Recent history of asthma (within the last 3 years)
- •History of seizure disorder, bipolar disorder, schizophrenia, or other significant or unstable medical or psychiatric illness that may place the participant at increased risk in the judgment of the medical clinician
- •Significant risk of homicide or suicide
研究组 & 干预措施
NAC plus CM
N-acetylcysteine (NAC) plus Contingency Management (CM)
干预措施: N-Acetylcysteine (Drug)
Placebo plus CM
Placebo plus Contingency Management (CM)
干预措施: Placebo (Drug)
结局指标
主要结局
The Odds of Negative Urine Cannabinoid Tests During Treatment.
时间窗: study weeks 2-13
The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.
次要结局
未报告次要终点
研究者
Kevin Gray, MD
Associate Professor
Medical University of South Carolina