Effects of Extended Cannabis Abstinence on Symptoms and Cognition in Depressed Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- The effects of 28 day cannabis abstinence on change in depressive symptoms in cannabis-dependent patients with Major Depressive Disorder (MDD) as assessed by the Hamilton Rating Scale for Depression (HRSD).
研究概览
简要总结
The objective of this study is to assess the changes in symptoms and cognition that occur after a 28-day abstinence period in patients with comorbid Cannabis Use Disorder (CUD) and Major Depression (MDD). This study employs a 28-day abstinence paradigm a total of 8 visits to the CAMH Russell site (screening, training, baseline, week 1, week 2, week 3, week 4, follow-up). Participants should be between the ages of 18-55, meet criteria for moderate depression and CUD, be non-treatment seeking, and be on a stable dose of antidepressant medication. The study visits will take up a total of approximately 22.5 hours with compensation for time provided. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •ages 18-55
- •meet DSM-5 diagnostic criteria for cannabis use disorder (cannabis use >1 g/day, CUDIT score >12)
- •meet DSM-5 diagnostic criteria for Major Depressive Disorder as determined using the SCID
- •be an outpatient receiving a stable dose of antidepressant medication(s) for at least 1 month
- •have a Hamilton Depression Rating Scale (HDRS-17) baseline total score greater than 14
- •have a Full Scale IQ greater than 80 as determined by the WTAR
- •be a non-treatment seeking cannabis user
- •evidence of sufficient motivation and effort as measure by a Test of Memory Malingering (TOMM) score greater than 45
- •urinary baseline THC-COOH levels greater than 150 ng/ml
排除标准
- •meets criteria for abuse or dependence of alcohol or other illicit substances within the part 6 months (with the exception of cannabis, nicotine, or caffeine)
- •positive urine screen for illicit substances other than cannabis, nicotine or caffeine
- •current suicidal or homicidal ideation
- •psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID
- •head injury with loss of consciousness greater than 2 minutes or requiring hospitalization
- •neurological or medical condition determined to effect cognition
- •be treatment seeking for cannabis use
结局指标
主要结局
The effects of 28 day cannabis abstinence on change in depressive symptoms in cannabis-dependent patients with Major Depressive Disorder (MDD) as assessed by the Hamilton Rating Scale for Depression (HRSD).
时间窗: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel. The HRDS is used to evaluate depression on a 17-item scale with higher values indicating worse depressive symptoms.
次要结局
- The effects of 28 day cannabis abstinence on change in co-occurring anxiety in cannabis dependent patients with MDD as assessed by the Beck Anxiety Inventory (BAI) administered weekly.(Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56))
- The effects of 28 day cannabis abstinence on change in cognitive function in cannabis dependent patients with Major Depressive Disorder (MDD) as assessed by a cognitive battery administered at Baseline, Week 2, Endpoint and Follow-Up.(Bi-Weekly (Day 0, Day 14, Day 28) and at 8 Weeks (Follow-up Day 56))
研究者
Tony George
Chief, Addictions Division
Centre for Addiction and Mental Health