CANDIS-II: Evaluation of the Cognitive-behavioral Treatment Programme CANDIS

Cannabis Use Disorders Clinical Trial

— CANDIS-II  

Official title:

Evaluation of the Cognitive-behavioral Treatment Programme CANDIS in the German Outpatient Treatment Service System (CANDIS-II)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00673647
• Other study ID #: IIA5-2507DSM407
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 1, 2008
• Last updated: August 25, 2009
• Start date: May 2008
• Est. completion date: October 2009

Study information

• Verified date: August 2009
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of the cognitive-behavioral treatment program CANDIS among n=450 patients with cannabis use disorders in a mulicenter randomized-controlled clinical trial (n=11 outpatient treatment centers).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• motivation to change cannabis use

• age 16 or older

• current (12 mth) regular cannabis use (at least 2 days a week)

• informed consent to the study procedures and assessments

Exclusion Criteria:

• current alcohol or any illicit drug dependence syndrome according to DSM-IV other than due to cannabis

• lifetime history of any psychotic disorder

• current severe episode of Major depression

• current panic-agoraphobic disorder (severe)

• severe learning disability, brain damage or pervasive developmental disorder

• currently acute suicidality

• not fluent in german language

• any other current treatment for cannabis use disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis Use Disorders

Intervention

Behavioral:
• Cognitive-behavioral treatment
10 sessions of individual psychotherapy including cognitive-behavioral treatment, motivational enhancement and a psychosocial problem training.

Locations

Country	Name	City	State
Germany	Psychosoziale Beratungs- und Behandlungsstelle für Suchtgefährdete und -kranke	Bautzen
Germany	LogIn Jugend- und Suchtberatung	Berlin
Germany	Therapieladen e.V.	Berlin
Germany	Jugend- und Drogenberatung Braunschweig	Braunschweig
Germany	Jugend- und Drogenberatung Dresden	Dresden
Germany	Die Boje - Suchtberatung und Behandlung	Hamburg
Germany	Drobs Hannover	Hannover
Germany	Caritas-Fachambulanz für junge Suchtkranke	Muenchen
Germany	Suchtambulanz der LWL-Klinik Münster	Muenster
Germany	Caritas Fachambulanz für Suchtprävention und Rehabilitation Osnabrück	Osnabrueck
Germany	Release Stuttgart e.V. & Ambulante Beratungs- und Behandlungsstelle Klinikum Stuttgart	Stuttgart

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Federal Ministry of Health

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abstinence, defined as no evidence of cannabis use during the past 4 weeks as evidenced by self report and a negative urine screen; number of times a cannabis product was used in the past 4 weeks; retention rate		at the end of treatment	Yes

External Links

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