Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252980
Status:
UNKNOWN
Last Update Posted:
2007-01-17
First Post:
2005-11-14
Brief Title:
CANDIS - Targeted Treatment for Cannabis Disorders
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
CANDIS -Targeted Treatment for Cannabis Disorders
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 240000 adult Germans fulfill DSM-IV criteria for cannabis dependence and 140000 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 STTST 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 n70 including motivational enhancement cognitive-behavioral and psychosocial problem solving treatment components 2 TST n70 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 n70 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 STTST group n140 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
Aims 1 To develop a modular treatment program STTST 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 n70 including motivational enhancement cognitive-behavioral and psychosocial problem solving treatment components 2 TST n70 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 n70 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 STTST group n140 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None