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

August 25, 2009 updated by: Technische Universität Dresden

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bautzen, Germany, 02625
        • Psychosoziale Beratungs- und Behandlungsstelle für Suchtgefährdete und -kranke
      • Berlin, Germany, 10585
        • LogIn Jugend- und Suchtberatung
      • Berlin, Germany, 10783
        • Therapieladen e.V.
      • Braunschweig, Germany, 38102
        • Jugend- und Drogenberatung Braunschweig
      • Dresden, Germany, 01219
        • Jugend- und Drogenberatung Dresden
      • Hamburg, Germany, 20146
        • Die Boje - Suchtberatung und Behandlung
      • Hannover, Germany, 30159
        • Drobs Hannover
      • Muenchen, Germany, 80335
        • Caritas-Fachambulanz für junge Suchtkranke
      • Muenster, Germany, 48147
        • Suchtambulanz der LWL-Klinik Münster
      • Osnabrueck, Germany, 49074
        • Caritas Fachambulanz für Suchtprävention und Rehabilitation Osnabrück
      • Stuttgart, Germany, 70190
        • Release Stuttgart e.V. & Ambulante Beratungs- und Behandlungsstelle Klinikum Stuttgart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Individual psychotherapy including cognitive behavioral components, motivational interviewing techniques and case management
Behavioral: Cognitive-behavioral treatment
10 sessions of individual psychotherapy including cognitive-behavioral treatment, motivational enhancement and a psychosocial problem training.
Other Names:
  • delayed treatment control group
No Intervention: 2
Delayed treatment control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: at the end of treatment
at the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

Federal Ministry of Health

Investigators

  • Study Director: Hans-Ulrich Wittchen, PhD, Technische Universitaet Dresden
  • Study Director: Gerhard Buehringer, PhD, Technische Universitaet Dresden
  • Principal Investigator: Eva Hoch, PhD, Technische Universitaet Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2009

Last Update Submitted That Met QC Criteria

August 25, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIA5-2507DSM407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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