CANDIS-II: Evaluation of the Cognitive-behavioral Treatment Programme CANDIS
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Dresden University of Technology.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Dresden University of Technology
Collaborator:
Federal Ministry of Health
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00673647
First received: May 1, 2008
Last updated: August 25, 2009
Last verified: August 2009
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | May 1, 2008 | ||||||||||||
| Last Updated Date | August 25, 2009 | ||||||||||||
| Start Date ICMJE | May 2008 | ||||||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00673647 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | CANDIS-II: Evaluation of the Cognitive-behavioral Treatment Programme CANDIS | ||||||||||||
| Official Title ICMJE | Evaluation of the Cognitive-behavioral Treatment Programme CANDIS in the German Outpatient Treatment Service System (CANDIS-II) | ||||||||||||
| Brief 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). |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 3 | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Cannabis Use Disorders | ||||||||||||
| Intervention ICMJE | Behavioral: Cognitive-behavioral treatment
10 sessions of individual psychotherapy including cognitive-behavioral treatment, motivational enhancement and a psychosocial problem training.
Other Name: delayed treatment control group |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 450 | ||||||||||||
| Estimated Completion Date | October 2009 | ||||||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 16 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Germany | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00673647 | ||||||||||||
| Other Study ID Numbers ICMJE | IIA5-2507DSM407 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | PhD Eva Hoch, Technische Universitaet Dresden | ||||||||||||
| Study Sponsor ICMJE | Dresden University of Technology | ||||||||||||
| Collaborators ICMJE | Federal Ministry of Health | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Dresden University of Technology | ||||||||||||
| Verification Date | August 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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