Gender and Sex Hormone Influences on Cannabis Use Disorder Remission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Proportion of participants in remission
研究概览
简要总结
Adults (ages 18+) who would like to reduce their cannabis use (N=224) will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1-, 2-, and 3-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Salivary samples will be collected (and video observed) daily throughout treatment to analyze for progesterone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate in a research study (otherwise, will be referred to appropriate clinical services if seeking clinical care).
- •Meet current (within last 30 days) DSM-5 criteria for cannabis use disorder.
- •Submit a positive urine cannabinoid test during screening.
- •Interested in treatment for cannabis use disorder.
排除标准
- •Significant or acutely unstable medical or psychiatric problems (i.e., psychosis, mania) that would contraindicate research procedures, interfere with safety, compromise data integrity, or preclude consistent study participation.
- •The presence of any substance use disorder requiring a higher level of care.
- •Significant risk of homicide or suicide.
- •Pregnant, trying to become pregnant, or breastfeeding.
结局指标
主要结局
Proportion of participants in remission
时间窗: Week 20
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Reduction in cannabis use days
时间窗: 8 weeks of treatment
Number of cannabis use days assessed via daily diaries during treatment
Reduction in cannabis use episodes
时间窗: 8 weeks of treatment
Number of cannabis use episodes assessed via daily diaries during treatment
次要结局
未报告次要终点