Cannabinoid Medication for Adults With OCD

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StatusDovršeno

Sponzori

New York State Psychiatric Institute

KLINIČKO ISPITIVANJE: NCT02911324

BioSeek: nct02911324

Ključne riječi

Sažetak

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.

Datumi

Posljednja provjera:	01/31/2020
Prvo podneseno:	09/11/2016
Predviđena prijava poslana:	09/19/2016
Prvo objavljeno:	09/21/2016
Posljednje ažuriranje poslano:	02/26/2020
Posljednje ažuriranje objavljeno:	02/27/2020
Datum prvog podnošenja rezultata:	01/09/2020
Datum prvog podnošenja rezultata QC:	02/26/2020
Datum prvog objavljivanja rezultata:	02/27/2020
Stvarni datum početka studija:	08/31/2016
Procijenjeni datum primarnog završetka:	12/31/2018
Procijenjeni datum završetka studije:	12/31/2018

Stanje ili bolest

Obsessive-Compulsive Disorder

Intervencija / liječenje

Drug: Nabilone

Behavioral: Nabilone and EX/RP

Faza

Faza 1/Faza 2

Grupe ruku

Ruka	Intervencija / liječenje
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.

Kriterij prihvatljivosti

Dobni uvjeti za studiranje	18 Years Do 18 Years
Spolovi koji ispunjavaju uvjete za studij	All
Prihvaća zdrave volontere	Da
Kriteriji	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

Ishod

Primarne mjere ishoda

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

Sekundarne mjere ishoda

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

Ključne riječi

nabilone

cannabinoid

nausea

povraćanje

konoplja

kemoterapija