Effects of Extended Cannabis Abstinence on Clinical and Cognitive Outcomes in Patients With Co-Morbid Bipolar Disorder and Cannabis Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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 bipolar disorder 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 Bipolar (Type I or II) disorder. Stabilized bipolar patients (N=52) with CUD will be randomly assigned to one of two groups: 1) A contingent reinforcement (CR) group (n=26); 2) a non-contingent reinforcement (NCR) group (n=26). The study will include a total of 8 visits to the CAMH Russell site (screening, training, baselines, week 1-4, follow-up). Participants should be between the ages of 18-60, meet criteria for CUD (moderate to severe), meet criteria for Bipolar Disorder, be on a stable dose of mood stabilizing medication(s), and be non-treatment seeking cannabis user. The visits will take up a total of approximately 22.5 hours with compensation for time provided for both groups. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement for the CR group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants must be between the ages 18-60
- •Meet SCID for DSM-5 diagnostic criteria for cannabis use disorder, moderate to severe
- •Meet SCID for DSM-5 diagnostic criteria for Bipolar Disorder (Type I or II)
- •Be an outpatient receiving a stable dose of mood stabilizing medication(s) for at least one month
- •Have a Hamilton Depression Rating Scale (HDRS-17) baseline assessment in the range of 12-25
- •Have a Full-Scale IQ of at least 80 as determined by the WTAR
- •Be a non-treatment seeking cannabis user
- •Evidence of sufficient motivation and effort as measured by a Test of Memory Malingering (TOMM) score of at least 45
- •Y-MRS baseline score in the range of 0-15
排除标准
- •Meets criteria for abuse or dependence of alcohol or other illicit substances within the past 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
- •Treatment seeking for cannabis use
- •Head Injury > 5 minutes LOC
- •Exceed upper and lower cut-offs on HSRD-17 and YMRS
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 bipolar disorder 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 effects of 28 day cannabis abstinence on change in hypomania symptoms in cannabis-dependent patients with bipolar disorder as assessed by the Young Mania Rating Scale (YMRS).
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.
次要结局
- The effects of 28 day cannabis abstinence on change in cognitive function in cannabis dependent patients with bipolar disorder 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))
- The effects of 28 day cannabis abstinence on change in co-occurring anxiety in cannabis dependent patients with bipolar disorder as assessed by the Beck Anxiety Inventory (BAI).(Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56))
研究者
Tony George
Chief, Addictions Division
Centre for Addiction and Mental Health