CANDIS - Targeted Treatment for Cannabis Disorders

January 15, 2007 updated by: Technische Universität Dresden

CANDIS -Targeted Treatment for Cannabis Disorders

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

210

Phase

  • Phase 2

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

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:

  • 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

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: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- 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

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

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Eva Hoch, PhD, Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology
  • Study Director: Hans-Ulrich Wittchen, PhD, Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology
  • Study Director: Gerhard Bühringer, PhD, Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology

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

January 1, 2006

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

November 14, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 17, 2007

Last Update Submitted That Met QC Criteria

January 15, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01EB0440

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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