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Cannabinoid Medication for Adults With OCD

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New York State Psychiatric Institute

关键词

抽象

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.

日期

最后验证: 01/31/2020
首次提交: 09/11/2016
提交的预估入学人数: 09/19/2016
首次发布: 09/21/2016
上次提交的更新: 02/26/2020
最近更新发布: 02/27/2020
首次提交结果的日期: 01/09/2020
首次提交质量检查结果的日期: 02/26/2020
首次发布结果的日期: 02/27/2020
实际学习开始日期: 08/31/2016
预计主要完成日期: 12/31/2018
预计完成日期: 12/31/2018

状况或疾病

Obsessive-Compulsive Disorder

干预/治疗

Drug: Nabilone

Behavioral: Nabilone and EX/RP

相 1/相 2

手臂组

干预/治疗
Experimental: Nabilone
Will receive nabilone at 1 mg daily (BID) over 4 weeks.
Experimental: Nabilone and EX/RP
Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.
Behavioral: Nabilone and EX/RP
Exposure and Response Prevention Therapy (EX/RP) is a type of Cognitive-Behavioral Therapy for OCD that involves intentionally confronting situations that trigger obsessional distress while refraining from doing compulsions.

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

结果

主要结果指标

1. Change in Yale-Brown Obsessive Compulsive Scale [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

次要成果指标

1. Feasibility of Recruitment [Through study completion, an average of 1 year.]

Number of eligible participants recruited per month over a 1 year period.

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