Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis - Full Text View

Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis (CapOpus)

This study is currently recruiting participants.

Verified by Bispebjerg Hospital, January 2009

First Received: June 6, 2007 Last Updated: January 27, 2009 History of Changes

Sponsors and Collaborators:	Bispebjerg Hospital Copenhagen Trial Unit, Center for Clinical Intervention Research Sygekassernes Helsefond Københavns Kommune The Lundbeck Foundation
Information provided by:	Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT00484302

Purpose

The purpose of the trial is to investigate the effect of specialized treatment of cannabis abuse among young people with psychosis. The specialized treatment consists of manualized individual treatment and group therapy. It will be compared with the standard treatment, which consists of non-specialized, non-manualized treatment. 140 patients will be randomised to one of the two treatments, and the investigator(s) will be blinded to the treatment received.

Condition	Intervention
Marijuana Abuse Psychotic Disorders Schizophrenia	Behavioral: Cognitive behavioral therapy with motivational interviewing Behavioral: Non-manualized standard treatment

MedlinePlus related topics: Marijuana Psychotic Disorders Schizophrenia

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Cannabis and Psychosis. Randomized Clinical Trial: Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:

Number of cannabis-abstinent days [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychotic symptoms [ Time Frame: At observation points ] [ Designated as safety issue: No ]
Cognitive functioning [ Time Frame: At observation points ] [ Designated as safety issue: No ]
Social functioning [ Time Frame: At observation points ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: At observation points ] [ Designated as safety issue: No ]
Client satisfaction [ Time Frame: At observation points ] [ Designated as safety issue: No ]
Cost of treatment [ Time Frame: From inclusion until end of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CapOpus: Experimental	Behavioral: Cognitive behavioral therapy with motivational interviewing Individual and group therapy, education of family and case-manager. Behavioral: Non-manualized standard treatment Treatment by case-manager
Treatment as usual: Active Comparator	Behavioral: Non-manualized standard treatment Treatment by case-manager

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient must fulfil research criteria for F2 in ICD-10 (schizophrenia and schizophrenia-like conditions) and diagnosis of F12 (mental illness or disturbances caused by cannabis)
The patient must understand Danish language to the extent that assessment and treatment can be conducted without an interpreter.
The patient must give informed consent to participate in the trial. In addition, the patient must consent to participate in the specialized treatment (CapOpus) and consent to continuation or initiation of treatment for the psychiatric condition.
Patients in OPUS, Assertive Community Treatment, Community Mental Health Centres, psychiatric wards, and others who meet the criteria can be included in the trial. (OPUS is a treatment for young people with first-episode psychosis in Copenhagen - www.opus-kbh.dk)
Cannabis abuse must be the dominant form of abuse. Other substance abuse can be present sporadically.
Patients must be 18 to 35 years of age and have legal residence in or near the municipality of Copenhagen or Frederiksberg

Exclusion Criteria:

Patients who meet the criteria of alcohol-dependence syndrome (F10.2), opioid dependence syndrome (F11.2) or cocaine dependence syndrome (F14.2)
Patients who do not give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484302

Contacts

Contact: Merete Nordentoft, MD, PhD, MPH

+4520607552

merete.nordentoft@dadlnet.dk

Locations

Denmark
Bispebjerg Hospital, Psykiatrisk Afdeling, Forskningsenheden	Recruiting
Copenhagen, Denmark, 2400
Contact: Merete Nordentoft, MD, PhD, MPH +4520607552 merete.nordentoft@dadlnet.dk

Sponsors and Collaborators

Bispebjerg Hospital

Copenhagen Trial Unit, Center for Clinical Intervention Research

Sygekassernes Helsefond

Københavns Kommune

The Lundbeck Foundation

Investigators

Study Director:	Merete Nordentoft, MD, PhD, MPH	Bispebjerg Hospital
Principal Investigator:	Merete Nordentoft, MD, PhD, MPH	Bispebjerg Hospital

More Information

Additional Information:

CapOpus' English-language webpage This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Copenhagen University Hospital, Psychiatric Center Bispebjerg ( Professor, Dr.med. Merete Nordentoft )
Study ID Numbers:	CapOpus
Study First Received:	June 6, 2007
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00484302 History of Changes
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:

Marijuana Abuse
Psychotic Disorders
Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Behavior, Addictive
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Psychotic Disorders
Marijuana Abuse
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

Psychotic Disorders
Marijuana Abuse
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009