Efficacy of Contingency Management in the Treatment of Adolescents With Cannabis Use Disorders
Primary Purpose
Marijuana Abuse
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Standard treatment
Standard Treatment Plus Contingency Management Program
Sponsored by
About this trial
This is an interventional treatment trial for Marijuana Abuse
Eligibility Criteria
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)
Sites / Locations
- Hospital Clinic BarcelonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard treatment
Experimental
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Percentage of marijuana active users
Secondary Outcome Measures
Percentage of negative urine-screens
Percentage of completed intervention sessions
Scores in psychopathology and drug scales (T-ASI, SDQ, BDI, Cannabis Problem Questionnaire)
Full Information
NCT ID
NCT00878852
First Posted
April 8, 2009
Last Updated
May 20, 2009
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT00878852
Brief Title
Efficacy of Contingency Management in the Treatment of Adolescents With Cannabis Use Disorders
Official Title
Efficacy of a Contingency Management Program in the Treatment of Adolescents With Cannabis Use Disorders in a Child and Adolescent Psychiatry and Psychology Department
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard treatment
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard Treatment Plus Contingency Management Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of marijuana active users
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of negative urine-screens
Time Frame
12 weeks
Title
Percentage of completed intervention sessions
Time Frame
12 weeks
Title
Scores in psychopathology and drug scales (T-ASI, SDQ, BDI, Cannabis Problem Questionnaire)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Goti, M.D
Phone
0034932279970
Email
jgoti@clinic.ub.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Goti, M.D
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08015
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
12460133
Citation
Stephens RS, Babor TF, Kadden R, Miller M; Marijuana Treatment Project Research Group. The Marijuana Treatment Project: rationale, design and participant characteristics. Addiction. 2002 Dec;97 Suppl 1:109-24. doi: 10.1046/j.1360-0443.97.s01.6.x.
Results Reference
background
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Efficacy of Contingency Management in the Treatment of Adolescents With Cannabis Use Disorders
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