- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00878852
Efficacy of Contingency Management in the Treatment of Adolescents With Cannabis Use Disorders
Efficacy of a Contingency Management Program in the Treatment of Adolescents With Cannabis Use Disorders in a Child and Adolescent Psychiatry and Psychology Department
Cannabis use among Spanish adolescents has been increasing in the last decade. It has been related to poor school achievement, delinquency, substance use and psychiatric disorders. Furthermore, psychoactive substance use in adolescents presenting psychiatric disorders can result in the development of substance use disorders or the worsening of psychopathology. Thus, there's an urge to develop efficient interventions in the treatment of these disorders. Therapeutic approaches based on cognitive-behavioural therapy and motivational interviewing have demonstrated a limited efficacy in this population. Programs based on contingency management have been reported to be useful both in adult and adolescents, too. But it still remains unclear whether a combination of these therapeutic approaches is feasible and brings a better cost-benefit relation.
The investigators' project aims to evaluate the added benefits of supplementing a standard intervention on cannabis use, based on combined approach that includes motivational and cognitive-behavioural elements, with a contingency management program. Therefore, pre and post-treatment evaluation will be carried forward in a sample of 30 adolescents (aged 12-18) that initiate treatment for cannabis use related disorder at the Child and Adolescent Psychiatry Department of the Hospital Clinic in Barcelona. Participants will be randomly assigned to a standard treatment group or an experimental group in which standard treatment will be supplemented with a contingency management protocol. As a secondary objective, a prospective assessment of neuropsychological performance related to cannabis use or abstinence will be carried forward.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Javier Goti, M.D
- Phone Number: 0034932279970
- Email: jgoti@clinic.ub.es
Study Locations
-
-
-
Barcelona, Spain, 08015
- Recruiting
- Hospital Clinic Barcelona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Presence of DSM-IV-TR criteria of cannabis abuse and/or dependence
- Signed informed consent
Exclusion Criteria:
- Mental retardation
- Presence of a substance use disorder other than nicotine or cannabis
- Severe or unstable medical
- Presence at the moment of inclusion of severe acute psychopathology (acute psychotic symptoms, severe depressive symptoms, suicidal ideation)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard treatment
Participants will be randomly assigned to a standard treatment group.
Patients allocated to this group will receive active treatment in form of a 12-session intervention program.
This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001)
|
Participants will be randomly assigned to a standard treatment group.
Patients allocated to this group will receive active treatment in form of 12-session intervention program.
This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001).
Intervention includes Motivational interviewing (2 sessions) and Cognitive behavioral therapy
|
Experimental: Experimental
Participants randomly assigned to this group will received standard treatment (including 12 session therapy program) supplemented with an intervention with a contingency management program, designed to improve adherence and efficacy of the treatment program.
|
Participants assigned to this group will receive active treatment in form of 12-session intervention program.
This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001).
Intervention includes Motivational interviewing (2 sessions) and Cognitive behavioral therapy (10 sessions).
This treatment protocol will be supplemented with a contingency management intervention.
Intervention will consist in a voucher program: negative urine-screens will be rewarded with vouchers.
Voucher will have an increasing value.
At the end of the program, vouchers can be changed by gifts.
Potential gifts will be selected by the therapists and will be related to pro-social activities, aiming to change preexisting risk behaviours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of marijuana active users
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of negative urine-screens
Time Frame: 12 weeks
|
12 weeks
|
Percentage of completed intervention sessions
Time Frame: 12 weeks
|
12 weeks
|
Scores in psychopathology and drug scales (T-ASI, SDQ, BDI, Cannabis Problem Questionnaire)
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Javier Goti, M.D, Hospital Clinic of Barcelona
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI08/90331
- 4363/2008 (Ethics Comitee HCP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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