Pilot Trial on the Efficacy of Contingency Management for Six Months of Cannabis Abstinence Among Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Continuous Abstinence Via Progressive Declines in Urine THCCOOH
研究概览
简要总结
This study is a critically important first-of-its-kind investigation of the potential research utility of using contingency management to examine long-term changes in cannabis use with six months of abstinence. These pilot data will inform a later trial which will focus on testing the longitudinal relationships between adolescent cognition and cannabis use, questions of high and growing public health significance given adolescents' increased access to cannabis with legalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adolescents actively enrolled in a middle or high school in the Boston area who are between the ages of 13 and 19 (inclusive);
- •Average use of cannabis at least 3 times per week during the 3 months prior to study enrollment;
- •Cannabis use reported within 7 days of study enrollment;
- •No immediate plan to discontinue cannabis use;
- •Have a parent or legal guardian who is competent and willing to provide written informed consent for the active study phase (if under the age of 18);
- •Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
- •Competent and willing to provide written informed consent (if age 18 or older);
- •Able to communicate in English language;
- •Have a parent/guardian who can communicate in English language;
- •Able to commit to 27 study visits in approximately 6 months;
- •Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator.
排除标准
- •Any severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome).
结局指标
主要结局
Continuous Abstinence Via Progressive Declines in Urine THCCOOH
时间窗: Six months
Cannabis abstinence will be indexed by progressively decreasing quantitative levels (ng/mL) of 11-nor-delta-9-THC-9-carboxylic acid (THCCOOH), the primary cannabis metabolite, in urine. Residual cannabinoid excretion will be differentiated from new cannabis exposure using a statistical model developed by Schwilke and colleagues (2011). This model was empirically derived from urine CN-THCCOOH concentration ratios of consecutively collected specimen pairs (current specimen/prior specimen). This model takes into account the time between collection of specimens, which enhances the accuracy of prediction of new cannabis use. This formula yields an expected CN-THCCOOH ratio associated with specimen pairs during abstinence, and observed ratios that exceed this expected value are interpreted as new cannabis use.
次要结局
未报告次要终点
研究者
Randi Melissa Schuster
Assistant Professor
Massachusetts General Hospital