Cannabis Use DisorderPhase 2NCT00252980
CANDIS - Targeted Treatment for Cannabis Disorders
A Phase 2 study testing Psychotherapy in people with Cannabis Use Disorder, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department for Clinical Psychology and Psychotherapy; Technical University of Dresden
Dresden
About this study
Official title: 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.
Read the 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.
- Conditions
- Cannabis Use Disorder
- Being tested
- Psychotherapy
- Keywords
- Cannabis, Dependence, Marijuana, Substance Abuse Treatment, Psychotherapy,
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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 outcomes (1)
- number of slips; relapse; abstinence from all legal drugs; number of times of drug use other than cannabis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJan 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Eva Hoch, PhD, Principal investigator, Departement of Clinical Psychology and Psychotherapy, Dresden University of TechnologyHans-Ulrich Wittchen, PhD, Study director, Departement of Clinical Psychology and Psychotherapy, Dresden University of TechnologyGerhard Bühringer, PhD, Study director, Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252980
- Sponsor's protocol ID
- 01EB0440
- Status last verified
- Jan 2007
- First submitted
- 14 Nov 2005
- Last updated
- 17 Jan 2007
- Results posted
- No
Publications
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.
PubMed 21865014
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CANDIS -Targeted Treatment for Cannabis Disorders
- ClinicalTrials.gov ID
- NCT00252980
- Acronym / sponsor ID
- 01EB0440
- Conditions
- Cannabis Use Disorder
- Keywords
- Cannabis, Dependence, Marijuana, Substance Abuse Treatment, Psychotherapy,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Mar 2007
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy | Behavioural | – |
Primary outcome
- 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
1 secondary outcome
- number of slips; relapse; abstinence from all legal drugs; number of times of drug use other than cannabis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2007.
- Derived from this study: PubMed 21865014Hoch 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.
- homepage of the candis-project (for participants)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Hoch, PhD principal investigator
Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology
Hans-Ulrich Wittchen, PhD study director
Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology
Gerhard Bühringer, PhD study director
Departement of Clinical Psychology and Psychotherapy, Dresden University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psychotherapy in people with Cannabis Use Disorder, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00252980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2007.