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

NCT00484302 | Completed DMC

• 1 other identifier: CapOpus
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Marijuana Abuse; Psychotic Disorders; Schizophrenia

Keywords

Marijuana Abuse; Psychotic Disorders; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Number of cannabis-abstinent days in past month

  Baseline, 6 months, 10 months

Secondary Outcomes (6)

• Psychotic symptoms

  Baseline, 6 months, 10 months

• Cognitive functioning

  Baseline, 6 months, 10 months

• Social functioning

  Baseline, 6 months, 10 months

• Quality of life

  Baseline, 6 months, 10 months

• Client satisfaction

  6 months

Study Arms (2)

CapOpus

EXPERIMENTAL

Behavioral: Cognitive behavioral therapy with motivational interviewing; Behavioral: Non-manualized standard treatment

Treatment as usual

ACTIVE COMPARATOR

Behavioral: Non-manualized standard treatment

Interventions

Cognitive behavioral therapy with motivational interviewing BEHAVIORAL

Individual and group therapy, education of family and case-manager.

CapOpus

Non-manualized standard treatment BEHAVIORAL

Treatment by case-manager

CapOpus; Treatment as usual

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Sygekassernes Helsefond: collaborator
• Københavns Kommune: collaborator
• Lundbeck Foundation: collaborator
• Psychiatric Center Copenhagen: collaborator

Study Sites (1)

Psychiatric Center Copenhagen, Forskningsenheden

Copenhagen, 2400, Denmark

Location

Related Publications (2)

• Toftdahl NG, Nordentoft M, Hjorthoj C. The Effect of Changes in Cannabis Exposure on Psychotic Symptoms in Patients With Comorbid Cannabis Use Disorder. J Dual Diagn. 2016 Apr-Jun;12(2):129-36. doi: 10.1080/15504263.2016.1176426. Epub 2016 Apr 12.

  PMID: 27070732 DERIVED

• Hjorthoj C, Fohlmann A, Larsen AM, Madsen MT, Vesterager L, Gluud C, Arendt MC, Nordentoft M. Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis. Trials. 2008 Jul 11;9:42. doi: 10.1186/1745-6215-9-42.

  PMID: 18620563 DERIVED

MeSH Terms

Conditions

Marijuana Abuse; Psychotic Disorders; Schizophrenia

Interventions

Cognitive Behavioral Therapy; Motivational Interviewing

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Merete Nordentoft, MD, PhD, MPH

  Psychiatric Center Copenhagen

  STUDY DIRECTOR

• Merete Nordentoft, MD, PhD, MPH

  Psychiatric Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 8, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 25, 2011

Record last verified: 2011-01

Locations

DK (1)