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

Primary Purpose

Cannabis Use Disorders

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Cognitive-behavioral treatment
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorders focused on measuring cannabis, dependence, marijuana, CBT, efficacy of CBT for cannabis use disorders

Eligibility Criteria

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

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

Sites / Locations

  • Psychosoziale Beratungs- und Behandlungsstelle für Suchtgefährdete und -kranke
  • LogIn Jugend- und Suchtberatung
  • Therapieladen e.V.
  • Jugend- und Drogenberatung Braunschweig
  • Jugend- und Drogenberatung Dresden
  • Die Boje - Suchtberatung und Behandlung
  • Drobs Hannover
  • Caritas-Fachambulanz für junge Suchtkranke
  • Suchtambulanz der LWL-Klinik Münster
  • Caritas Fachambulanz für Suchtprävention und Rehabilitation Osnabrück
  • Release Stuttgart e.V. & Ambulante Beratungs- und Behandlungsstelle Klinikum Stuttgart

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Individual psychotherapy including cognitive behavioral components, motivational interviewing techniques and case management

Delayed treatment control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 1, 2008
Last Updated
August 25, 2009
Sponsor
Technische Universität Dresden
Collaborators
Federal Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT00673647
Brief Title
CANDIS-II: Evaluation of the Cognitive-behavioral Treatment Programme CANDIS
Acronym
CANDIS-II
Official Title
Evaluation of the Cognitive-behavioral Treatment Programme CANDIS in the German Outpatient Treatment Service System (CANDIS-II)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden
Collaborators
Federal Ministry of Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorders
Keywords
cannabis, dependence, marijuana, CBT, efficacy of CBT for cannabis use disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Individual psychotherapy including cognitive behavioral components, motivational interviewing techniques and case management
Arm Title
2
Arm Type
No Intervention
Arm Description
Delayed treatment control group
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral treatment
Other Intervention Name(s)
delayed treatment control group
Intervention Description
10 sessions of individual psychotherapy including cognitive-behavioral treatment, motivational enhancement and a psychosocial problem training.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Ulrich Wittchen, PhD
Organizational Affiliation
Technische Universitaet Dresden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gerhard Buehringer, PhD
Organizational Affiliation
Technische Universitaet Dresden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eva Hoch, PhD
Organizational Affiliation
Technische Universitaet Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychosoziale Beratungs- und Behandlungsstelle für Suchtgefährdete und -kranke
City
Bautzen
ZIP/Postal Code
02625
Country
Germany
Facility Name
LogIn Jugend- und Suchtberatung
City
Berlin
ZIP/Postal Code
10585
Country
Germany
Facility Name
Therapieladen e.V.
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
Jugend- und Drogenberatung Braunschweig
City
Braunschweig
ZIP/Postal Code
38102
Country
Germany
Facility Name
Jugend- und Drogenberatung Dresden
City
Dresden
ZIP/Postal Code
01219
Country
Germany
Facility Name
Die Boje - Suchtberatung und Behandlung
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
Drobs Hannover
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Caritas-Fachambulanz für junge Suchtkranke
City
Muenchen
ZIP/Postal Code
80335
Country
Germany
Facility Name
Suchtambulanz der LWL-Klinik Münster
City
Muenster
ZIP/Postal Code
48147
Country
Germany
Facility Name
Caritas Fachambulanz für Suchtprävention und Rehabilitation Osnabrück
City
Osnabrueck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Release Stuttgart e.V. & Ambulante Beratungs- und Behandlungsstelle Klinikum Stuttgart
City
Stuttgart
ZIP/Postal Code
70190
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24176199
Citation
Hoch E, Buhringer G, Pixa A, Dittmer K, Henker J, Seifert A, Wittchen HU. CANDIS treatment program for cannabis use disorders: findings from a randomized multi-site translational trial. Drug Alcohol Depend. 2014 Jan 1;134:185-193. doi: 10.1016/j.drugalcdep.2013.09.028. Epub 2013 Oct 8.
Results Reference
derived
Links:
URL
http://www.candis-projekt.de
Description
Related Info
URL
http://www.psychologie.tu-dresden.de
Description
Related Info

Learn more about this trial

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

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