CANDIS - Targeted Treatment for Cannabis Disorders

Cannabis Use Disorder Clinical Trial

Official title:

CANDIS -Targeted Treatment for Cannabis Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00252980
• Other study ID #: 01EB0440
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 14, 2005
• Last updated: January 15, 2007
• Start date: January 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2007
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse

Intervention

Behavioral:
• Psychotherapy

Locations

Country	Name	City	State
Germany	Department for Clinical Psychology and Psychotherapy; Technical University of Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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
Primary	; decrease in ASI total score; retention rate
Secondary	- number of slips; relapse; abstinence from all legal drugs; number of times of drug use other than cannabis

External Links

•   homepage of the candis-project (for participants)