Cannabinoid Medication for Adults With OCD

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Rėmėjai

New York State Psychiatric Institute

KLINIKINIS TYRIMAS: NCT02911324

BioSeek: nct02911324

Raktažodžiai

Santrauka

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.

Datos

Paskutinį kartą patikrinta:	01/31/2020
Pirmasis pateikimas:	09/11/2016
Numatytas registravimas pateiktas:	09/19/2016
Pirmas paskelbtas:	09/21/2016
Paskutinis atnaujinimas pateiktas:	02/26/2020
Paskutinis atnaujinimas paskelbtas:	02/27/2020
Pirmųjų rezultatų pateikimo data:	01/09/2020
Pirmojo QC rezultatų pateikimo data:	02/26/2020
Pirmųjų paskelbtų rezultatų data:	02/27/2020
Faktinė studijų pradžios data:	08/31/2016
Numatoma pirminio užbaigimo data:	12/31/2018
Numatoma studijų užbaigimo data:	12/31/2018

Būklė ar liga

Obsessive-Compulsive Disorder

Intervencija / gydymas

Drug: Nabilone

Behavioral: Nabilone and EX/RP

Fazė

Fazė 1/Fazė 2

Rankų grupės

Ranka	Intervencija / gydymas
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.

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	All
Priima sveikus savanorius	Taip
Kriterijai	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

Rezultatas

Pirminės rezultatų priemonės

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

Antrinės rezultatų priemonės

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

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

Cannabinoid Medication for Adults With OCD

Raktažodžiai

nabilone

cannabinoid

pykinimas

vėmimas

kanapė

chemoterapija