Cannabinoid Medication for Adults With Obsessive-Compulsive Disorder (OCD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Yale-Brown Obsessive Compulsive Scale
研究概览
简要总结
The purpose of this pilot research study is to test the effects of a medication called nabilone (Cesamet) in adults with obsessive-compulsive disorder (OCD). Participants will receive either nabilone on its own, or nabilone in combination with a form of cognitive-behavioral therapy (CBT) called exposure and response prevention (EX/RP). Nabilone is a synthetic cannabinoid and acts on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. Nabilone is approved by the FDA for the treatment of chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.
详细描述
The two first-line treatments for OCD are a class of medications called serotonin reuptake inhibitors (SRIs) and a type of cognitive behavioral therapy called exposure and response prevention (EX/RP). But more than a third of patients with OCD do not respond to these treatments, and less then half become well. Thus, new treatment approaches are needed.
EX/RP is thought to involve fear extinction learning. Recent research suggests that modulators of the endocannabinoid system such as nabilone (a synthetic cannabinoid and agonist of the cannabinoid 1 receptor, CB1R) may enhance fear extinction learning and therefor could enhance EX/RP. However, nabilone could also work via modulating activity in cortico-striatal circuits, which contain high concentrations of CB1R, and thereby might reduce repetitive behaviors like compulsions seen in OCD.
To test both ideas, we will conduct a small pilot randomized trial to explore the effects of nabilone on its own for 4 weeks, vs. combined with EX/RP, in adult patients with OCD. This proof-of-concept study will investigate whether nabilone administration is feasible and well-tolerated in adult patients with OCD. The intent is to collect pilot data to support future grant applications.
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
- •Age 18-60
- •Physically healthy, not pregnant
- •Primary Obsessive-Compulsive Disorder (OCD)
- •Patient off all psychotropic (except selective serotonin reuptake inhibitors [SSRIs]) and other types of drugs likely to interact with nabilone
- •Ability to provide informed consent
- •Ability to tolerate a treatment free-period
排除标准
- •History of any significant medical condition that may increase the risk of participation
- •Females who are pregnant or nursing
- •Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation (e.g. lifetime psychosis or bipolar disorder)
- •Current substance use disorder or positive urine toxicology at screening, or any adverse reaction to a cannabinoid
- •Patients already receiving EX/RP
研究组 & 干预措施
Nabilone
Will receive nabilone at 1 mg daily (BID) over 4 weeks.
干预措施: Nabilone (Drug)
Nabilone and EX/RP
Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.
干预措施: Nabilone (Drug)
Nabilone and EX/RP
Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.
干预措施: Exposure and Response Prevention Therapy (Behavioral)
结局指标
主要结局
Change in Yale-Brown Obsessive Compulsive Scale
时间窗: Baseline (Week 0) and Week 4
Yale-Brown Obsessive Compulsive Scale (YBOCS) Minimum Value: 0 Maximum Value: 40 Higher scores indicate more severe symptoms Change in YBOCS is calculated by subtracting the Week 4 score from the baseline score
次要结局
- Feasibility of Recruitment(Through study completion, an average of 1 year.)
研究者
Reilly R. Kayser
Resident of Psychiatry
New York State Psychiatric Institute