Cannabis Use DisordersPhase 3CANDIS-IINCT00673647
CANDIS-II: Evaluation of the Cognitive-behavioral Treatment Programme CANDIS
A Phase 3 study testing Cognitive-behavioral treatment in people with Cannabis Use Disorders, run by Technische Universität Dresden at 11 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cannabis Use Disorders
- What is being tested?
- Cognitive-behavioral treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 11 sitesGermany
- Study dates
- May 2008to Oct 2009
- Phase
- Phase 3
- 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
- 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
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
- not fluent in german language
- any other current treatment for cannabis use disorders
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Psychosoziale Beratungs- und Behandlungsstelle für Suchtgefährdete und -kranke
Bautzen, 02625
LogIn Jugend- und Suchtberatung
Berlin, 10585
Therapieladen e.V.
Berlin, 10783
Jugend- und Drogenberatung Braunschweig
Braunschweig, 38102
Jugend- und Drogenberatung Dresden
Dresden, 01219
Die Boje - Suchtberatung und Behandlung
Hamburg, 20146
Drobs Hannover
Hanover, 30159
Caritas-Fachambulanz für junge Suchtkranke
München, 80335
Suchtambulanz der LWL-Klinik Münster
Münster, 48147
Caritas Fachambulanz für Suchtprävention und Rehabilitation Osnabrück
Osnabrück, 49074
Release Stuttgart e.V. & Ambulante Beratungs- und Behandlungsstelle Klinikum Stuttgart
Stuttgart, 70190
About this study
Official title: Evaluation of the Cognitive-behavioral Treatment Programme CANDIS in the German Outpatient Treatment Service System (CANDIS-II)
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).
- Conditions
- Cannabis Use Disorders
- Being tested
- Cognitive-behavioral treatment
- Keywords
- cannabis, dependence, marijuana, CBT, efficacy of CBT for cannabis use disorders
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral treatmentBehavioural
Also called delayed treatment control group
10 sessions of individual psychotherapy including cognitive-behavioral treatment, motivational enhancement and a psychosocial problem training.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Individual psychotherapy including cognitive behavioral components, motivational interviewing techniques and case management Receives: Behavioral: Cognitive-behavioral treatment |
| 2 | No intervention | Delayed treatment control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
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 DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health
- Investigators
- Hans-Ulrich Wittchen, PhD, Study director, Technische Universitaet DresdenGerhard Buehringer, PhD, Study director, Technische Universitaet DresdenEva Hoch, PhD, Principal investigator, Technische Universitaet Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673647
- Sponsor's protocol ID
- IIA5-2507DSM407
- Acronym
- CANDIS-II
- Status last verified
- Aug 2009
- First submitted
- 1 May 2008
- Last updated
- 26 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24176199
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cognitive-behavioral Treatment Programme CANDIS in the German Outpatient Treatment Service System (CANDIS-II)
- ClinicalTrials.gov ID
- NCT00673647
- Acronym / sponsor ID
- CANDIS-II / IIA5-2507DSM407
- Conditions
- Cannabis Use Disorders
- Keywords
- cannabis, dependence, marijuana, CBT, efficacy of CBT for cannabis use disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Federal Ministry of Health
- Study start
- May 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 7 May 2008 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive-behavioral treatmentIndividual psychotherapy including cognitive behavioral components, motivational interviewing techniques and case management |
| 2 | No intervention | –Delayed treatment control group |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 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 |
|---|---|---|
| Cognitive-behavioral treatmentAlso: delayed treatment control group10 sessions of individual psychotherapy including cognitive-behavioral treatment, motivational enhancement and a psychosocial problem training. | Behavioural | 1 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2009.
- Derived from this study: PubMed 24176199Hoch 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Cannabis Use Disorders
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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.
Hans-Ulrich Wittchen, PhD study director
Technische Universitaet Dresden
Gerhard Buehringer, PhD study director
Technische Universitaet Dresden
Eva Hoch, PhD principal investigator
Technische Universitaet Dresden
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive-behavioral treatment in people with Cannabis Use Disorders, run by Technische Universität Dresden at 11 sites 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 4 inclusion and 8 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 26 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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). 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 NCT00673647, 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 26 Aug 2009.