Effect of Extended Cannabis Abstinence on PTSD Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Severity of PTSD symptoms, as measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at week 4
研究概览
简要总结
This will be a 12-week randomized trial. Outpatients and patients from the Mood and Anxiety program at the Centre for Addiction and Mental Health (CAMH) with a current diagnosis of post-traumatic stressed disorder (PTSD) and cannabis-use disorder (CUD) will be randomized to receive individual motivational interviewing therapy and contingency management (n = 12) or individual motivational interviewing therapy alone (control group, n = 12) after enrolment.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 18 and 55 years (from both sexes [or genders]);
- •Diagnosed with CUD (moderate or severe) according to the Structured Clinical Interview for DSM-IV (SCID) (mode of cannabis consumption can be inhalation or ingestion);
- •Diagnosis of current (past 30 days) PTSD, using the CAPS-5 on screening;
- •On antidepressant medication(s) for at least 1 month (to ensure safety and homogeneity as PTSD treatment of our population);
- •Be able to provide written informed consent; and
- •Be able to communicate in English.
排除标准
- •diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per the study physician;
- •diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder or current acute psychosis or mania based on DSM-5 criteria;
- •current suicidality risk as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after the study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes" 34; and
- •have pain interfering with normal function as reported by the 12-Item Short Form Survey (SF-12) (moderate or higher interference).
结局指标
主要结局
Severity of PTSD symptoms, as measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at week 4
时间窗: Week 0-4
Changes in CAPS-5 during the study phase between the group that achieved abstinence and the group that did not. In addition, we will record changes in each PTSD symptom category, which will all be part of the larger trial analysis.
次要结局
- Changes in cognitive function, as measured with various Cambridge Automated Neuropsychological Test Automated Battery (CANTAB) cognitive tests(Week 0-4)
研究者
Ahmed N Hassan
Doctor
Centre for Addiction and Mental Health