NCT00878852

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

May 21, 2009

Status Verified

May 1, 2009

Enrollment Period

1.7 years

First QC Date

April 8, 2009

Last Update Submit

May 20, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of marijuana active users

    12 weeks

Secondary Outcomes (3)

  • Percentage of negative urine-screens

    12 weeks

  • Percentage of completed intervention sessions

    12 weeks

  • Scores in psychopathology and drug scales (T-ASI, SDQ, BDI, Cannabis Problem Questionnaire)

    12 weeks

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

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)

Behavioral: Standard treatment

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.

Behavioral: Standard Treatment Plus Contingency Management Program

Interventions

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

Standard treatment

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.

Experimental

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Presence of DSM-IV-TR criteria of cannabis abuse and/or dependence
  • Signed informed consent

You may not qualify if:

  • Mental retardation
  • Presence of a substance use disorder other than nicotine or cannabis
  • Severe or unstable medical

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Barcelona, 08015, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 12460133BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Javier Goti, M.D

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Goti, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 9, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Last Updated

May 21, 2009

Record last verified: 2009-05

Locations