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

This study has been completed.
Sponsor:
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Sygekassernes Helsefond
Københavns Kommune
Lundbeck Foundation
Psychiatric Center Copenhagen
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00484302
First received: June 6, 2007
Last updated: January 24, 2011
Last verified: January 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cannabis and Psychosis. Randomized Clinical Trial: Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Number of cannabis-abstinent days in past month [ Time Frame: Baseline, 6 months, 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychotic symptoms [ Time Frame: Baseline, 6 months, 10 months ] [ Designated as safety issue: No ]
  • Cognitive functioning [ Time Frame: Baseline, 6 months, 10 months ] [ Designated as safety issue: No ]
  • Social functioning [ Time Frame: Baseline, 6 months, 10 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline, 6 months, 10 months ] [ Designated as safety issue: No ]
  • Client satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cost of treatment [ Time Frame: After completed data collection ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: September 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CapOpus 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
Active Comparator: Treatment as usual 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Psychiatric Center Copenhagen, Forskningsenheden
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
Sygekassernes Helsefond
Københavns Kommune
Lundbeck Foundation
Psychiatric Center Copenhagen
Investigators
Study Director: Merete Nordentoft, MD, PhD, MPH Psychiatric Center Copenhagen
Principal Investigator: Merete Nordentoft, MD, PhD, MPH Psychiatric Center Copenhagen
  More Information

Additional Information:
No publications provided

Responsible Party: Professor, Dr.med. Merete Nordentoft, Copenhagen University Hospital, Psychiatric Center Copenhagen
ClinicalTrials.gov Identifier: NCT00484302     History of Changes
Other Study ID Numbers: CapOpus
Study First Received: June 6, 2007
Last Updated: January 24, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Marijuana Abuse
Psychotic Disorders
Schizophrenia

Additional relevant MeSH terms:
Marijuana Abuse
Mental Disorders
Psychotic Disorders
Schizophrenia
Substance-Related Disorders
Chemically-Induced Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 11, 2014