NCT00673647

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2008

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

May 1, 2008

Last Update Submit

August 25, 2009

Conditions

Cannabis Use Disorders

Keywords

cannabisdependencemarijuanaCBTefficacy of CBT for cannabis use disorders

Outcome Measures

Primary Outcomes (1)

  • 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

    at the end of treatment

Study Arms (2)

1

EXPERIMENTAL

Individual psychotherapy including cognitive behavioral components, motivational interviewing techniques and case management

Behavioral: Cognitive-behavioral treatment

2

NO INTERVENTION

Delayed treatment control group

Interventions

Cognitive-behavioral treatmentBEHAVIORAL

10 sessions of individual psychotherapy including cognitive-behavioral treatment, motivational enhancement and a psychosocial problem training.

Also known as: delayed treatment control group
1

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Psychosoziale Beratungs- und Behandlungsstelle für Suchtgefährdete und -kranke

Bautzen, 02625, Germany

Location

LogIn Jugend- und Suchtberatung

Berlin, 10585, Germany

Location

Therapieladen e.V.

Berlin, 10783, Germany

Location

Jugend- und Drogenberatung Braunschweig

Braunschweig, 38102, Germany

Location

Jugend- und Drogenberatung Dresden

Dresden, 01219, Germany

Location

Die Boje - Suchtberatung und Behandlung

Hamburg, 20146, Germany

Location

Drobs Hannover

Hanover, 30159, Germany

Location

Caritas-Fachambulanz für junge Suchtkranke

München, 80335, Germany

Location

Suchtambulanz der LWL-Klinik Münster

Münster, 48147, Germany

Location

Caritas Fachambulanz für Suchtprävention und Rehabilitation Osnabrück

Osnabrück, 49074, Germany

Location

Release Stuttgart e.V. & Ambulante Beratungs- und Behandlungsstelle Klinikum Stuttgart

Stuttgart, 70190, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24176199DERIVED

Related Links

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Hans-Ulrich Wittchen, PhD

    Technische Universitaet Dresden

    STUDY DIRECTOR

  • Gerhard Buehringer, PhD

    Technische Universitaet Dresden

    STUDY DIRECTOR

  • Eva Hoch, PhD

    Technische Universitaet Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 7, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

DE(11)