Cannabinoid Medication for Adults With OCD

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EstadoTerminado

Patrocinadores

New York State Psychiatric Institute

ENSAYO CLÍNICO: NCT02911324

BioSeek: nct02911324

Palabras clave

Abstracto

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.

fechas

Verificado por última vez:	01/31/2020
Primero enviado:	09/11/2016
Inscripción estimada enviada:	09/19/2016
Publicado por primera vez:	09/21/2016
Última actualización enviada:	02/26/2020
Última actualización publicada:	02/27/2020
Fecha de los primeros resultados enviados:	01/09/2020
Fecha de los primeros resultados de CC enviados:	02/26/2020
Fecha de los primeros resultados publicados:	02/27/2020
Fecha de inicio real del estudio:	08/31/2016
Fecha estimada de finalización primaria:	12/31/2018
Fecha estimada de finalización del estudio:	12/31/2018

Condición o enfermedad

Obsessive-Compulsive Disorder

Intervención / tratamiento

Drug: Nabilone

Behavioral: Nabilone and EX/RP

Fase

Fase 1/Fase 2

Grupos de brazos

Brazo	Intervención / tratamiento
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.

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Acepta voluntarios saludables	si
Criterios	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

Salir

Medidas de resultado primarias

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

Medidas de resultado secundarias

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

Palabras clave

nabilona

cannabinoid

náusea

vómito

cannabis

quimioterapia