Cannabinoid Medication for Adults With OCD

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StatusAbgeschlossen

Sponsoren

New York State Psychiatric Institute

KLINISCHE STUDIE: NCT02911324

BioSeek: nct02911324

Schlüsselwörter

Abstrakt

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.

Termine

Zuletzt überprüft:	01/31/2020
Zuerst eingereicht:	09/11/2016
Geschätzte Einschreibung eingereicht:	09/19/2016
Zuerst veröffentlicht:	09/21/2016
Letztes eingereichtes Update:	02/26/2020
Letztes Update veröffentlicht:	02/27/2020
Datum der ersten eingereichten Ergebnisse:	01/09/2020
Datum der ersten eingereichten QC-Ergebnisse:	02/26/2020
Datum der ersten veröffentlichten Ergebnisse:	02/27/2020
Tatsächliches Startdatum der Studie:	08/31/2016
Geschätztes primäres Abschlussdatum:	12/31/2018
Voraussichtliches Abschlussdatum der Studie:	12/31/2018

Zustand oder Krankheit

Obsessive-Compulsive Disorder

Intervention / Behandlung

Drug: Nabilone

Behavioral: Nabilone and EX/RP

Phase

Phase 1/Phase 2

Armgruppen

Arm	Intervention / Behandlung
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.

Zulassungskriterien

Altersberechtigt für das Studium	18 Years Zu 18 Years
Studienberechtigte Geschlechter	All
Akzeptiert gesunde Freiwillige	Ja
Kriterien	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

Ergebnis

Primäre Ergebnismaße

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

Sekundäre Ergebnismaße

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

Schlüsselwörter

nabilone

cannabinoid

übelkeit

erbrechen

femeln

chemotherapie