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CANDIS - Targeted Treatment for Cannabis Disorders

Primary Purpose

Cannabis Use Disorder

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Cannabis, Dependence, Marijuana, Substance Abuse Treatment, Psychotherapy,

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 16 or older lifetime diagnosis of cannabis abuse or cannabis dependence (according to the DSM-IV criteria current (4 wks) regular cannabis use (at least 2 days a week) persistent history of regular cannabis use of at least 3 years 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 acute signs of intoxication at screening or baseline assessment due to opiates or any type of stimulants, causing cognitive impairments currently in treatment for cannabis-related disorders in other services current psychotropic medications with sedatives and antipsychotics

Sites / Locations

  • Department for Clinical Psychology and Psychotherapy; Technical University of Dresden

Outcomes

Primary Outcome Measures

- total quit rates, 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
; decrease in ASI total score; retention rate

Secondary Outcome Measures

- number of slips; relapse; abstinence from all legal drugs; number of times of drug use other than cannabis

Full Information

First Posted
November 14, 2005
Last Updated
January 15, 2007
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00252980
Brief Title
CANDIS - Targeted Treatment for Cannabis Disorders
Official Title
CANDIS -Targeted Treatment for Cannabis Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to develop a modular treatment program for cannabis use disorders and the evaluation of the effectiveness in a controlled clinical study.
Detailed Description
Background. Cannabis is the most widely used illicit substance in the whole Western world and rates are further rising. Almost 240.000 adult Germans fulfill DSM-IV criteria for cannabis dependence and 140.000 the criteria for cannabis abuse (past 12-month), respectively. Several studies have revealed a considerable degree of unmet needs for intervention and treatment for cannabis disorders, for example in terms of associated physical, mental health, social and legal problems. The epidemiological significance of the problem is contrasted sharply with (1) strongly increasing treatment demand due to cannabis-related problems, (2) the lack of evidence-based interventions (motivational and early treatment) (3) the lack of specific services, and (4) the lack of treatment programs and components with established efficacy. With regard to treatment research there is a marked deficit with only a handful of studies up to date. Only in the US and Australia, some recent effort was undertaken to develop and evaluate cannabis-specific dependence treatment programs in controlled trials with highly selective samples. However, there are currently no 'state of the art' benchmark programs neither in Germany nor in other European countries that are suitable for routine use. Aims. (1) To develop a modular treatment program (ST/TST) for cannabis use disorders based on treatment packages and components that have been shown to be effective in previous US and Australian trials, and to adapt these material to the needs of our target population. (2) To demonstrate that this modular treatment package, implying motivational enhancement, cognitive-behavioral and psychosocial problem solving components is efficacious in comparison to a delayed treatment control (DTC) group. (3) Additionally, we test whether the targeted standardized treatment (TST) component tailored to address more specifically core problem areas results in superior short term (3-months) outcomes in these core domains as compared to the ST-group. Method. A randomized controlled intervention study is proposed. A total of 210 participants will be randomly assigned to two, respectively three study conditions: 1. ST (n=70) including motivational enhancement, cognitive-behavioral, and psychosocial problem solving treatment components, 2. TST (n=70), including the same components as the ST but partly individually matched to the specific problem profile of the patient, and (c) a delayed treatment control group (DTC, n=70). Core outcome variables are total quit rates, number of cannabis use in the past 4 weeks, decrease in ASI scores and retention rate. The core hypothesis will be tested in the combined ST/TST group (n=140). The ASI serves for the allocation algorithms in the TST group and serves as outcome measure for the 3rd hypothesis. The proposed study is innovative and will result in a considerable advancement of our knowledge about effective treatments in cannabis disorders and will inform about the value of targeted individualized allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder
Keywords
Cannabis, Dependence, Marijuana, Substance Abuse Treatment, Psychotherapy,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Primary Outcome Measure Information:
Title
- total quit rates, 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
Title
; decrease in ASI total score; retention rate
Secondary Outcome Measure Information:
Title
- number of slips; relapse; abstinence from all legal drugs; number of times of drug use other than cannabis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 16 or older lifetime diagnosis of cannabis abuse or cannabis dependence (according to the DSM-IV criteria current (4 wks) regular cannabis use (at least 2 days a week) persistent history of regular cannabis use of at least 3 years 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 acute signs of intoxication at screening or baseline assessment due to opiates or any type of stimulants, causing cognitive impairments currently in treatment for cannabis-related disorders in other services current psychotropic medications with sedatives and antipsychotics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Hoch, PhD
Organizational Affiliation
Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans-Ulrich Wittchen, PhD
Organizational Affiliation
Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gerhard Bühringer, PhD
Organizational Affiliation
Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department for Clinical Psychology and Psychotherapy; Technical University of Dresden
City
Dresden
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21865014
Citation
Hoch E, Noack R, Henker J, Pixa A, Hofler M, Behrendt S, Buhringer G, Wittchen HU. Efficacy of a targeted cognitive-behavioral treatment program for cannabis use disorders (CANDIS). Eur Neuropsychopharmacol. 2012 Apr;22(4):267-80. doi: 10.1016/j.euroneuro.2011.07.014. Epub 2011 Aug 24.
Results Reference
derived
Links:
URL
http://www.candis-projekt.de
Description
homepage of the candis-project (for participants)

Learn more about this trial

CANDIS - Targeted Treatment for Cannabis Disorders

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