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Adaptive Treatment for Adolescent Cannabis Use Disorders

This study is currently recruiting participants.
Verified February 2013 by University of Connecticut Health Center
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01656707
First received: August 1, 2012
Last updated: March 1, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to examine an Adaptive Treatment approach in order to improve outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.


Condition Intervention
Mental Disorders
Addictive Behaviors
Cannabis Use Disorder
 Behavioral: ACRA
Behavioral: CBT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptive Treatment for Adolescent Cannabis Use Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • 1.) To evaluate the efficacy of AT for youth who have been defined as poor responders to an evidence-based practice intervention such as the initial MET/CBT-7. [ Time Frame: one year ] [ Designated as safety issue: No ]
    Each participant will serve as his/her own control. The outcomes will include the T-ASI, T-ASI-P, and drug urinalyses.


Secondary Outcome Measures:
  • To assess outcomes as a function of mediator variables such as self-efficacy, coping skills, readiness to change, and environmental support (i.e., family and peer), within each of the AT interventions. [ Time Frame: one year ] [ Designated as safety issue: No ]
    The secondary outcome measures will include the SCQ, CRI, PRQ, and SSQ.


Estimated Enrollment: 230
Study Start Date: September 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACRA
Ten weekly 60-minute sessions of Adolescent Community Reinforcement Approach (ACRA) will be provided as an Adaptive treatment condition.
 Behavioral: ACRA
Ten weekly,60-minute therapy sessions including six individual, two parent/guardian and two joint (individual and parent/guardian).
Other Name: Adolescent Community Reinforcement Approach
Experimental: Cognitive Behavioral Therapy (CBT)
Ten weekly, 60-minute sessions of augmented individualized Cognitive Behavioral Therapy (CBT)will be provided as an Adaptive Treatment condition
 Behavioral: CBT
10 weekly, 60-minute sessions of augmented individualized CBT
Other Name: Cogntive Behavioral Therapy

Detailed Description:

The study will address the current contrasts in youth response to treatment, the problem of poor response to treatment and the prevention of relapse. Results from the study may support Adaptive Treatment as an efficacious approach for youth with Cannabis Use Disorder who are poor responders to treatment.

Poor responders fall into two categories, those who failed to achieve a negative drug urinalysis during the last session of the initial MET/CBT-7 treatment they attended, and those who either dropped out or were administratively discharged at any time during the initial MET/CBT-7 treatment.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 13-18 years of age at the time of intake assessment
  • Current diagnosis of DSM-IV Cannabis Abuse or Dependence
  • Able to read and comprehend English at a 5th grade level
  • Residence within 45 minutes drive from the UCHC Farmington treatment site
  • Participant and a parent/legal guardian responsible for providing collateral information agree to sign an IRB approved consent form
  • Participant and a parent/legal guardian responsible for providing collateral information agree to provide locator information
  • The family is not planning to move from the area during the next six months

Exclusion Criteria:

  • Meet criteria for dependence of any other substance of abuse other than nicotine or alcohol
  • Report suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or other, or a history of self-injurious behavior all occurring in the last 30 days
  • Meet a lifetime diagnosis of schizophrenia
  • Has any current health (i.e. medical, psychiatric) condition that will compromise the participant's ability to regularly attend treatment
  • Demonstrate an inability or unwillingness to provide locator information
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656707

Contacts
Contact: Yifrah Kaminer, MD, MBA 860-679-4344 kaminer@uchc.edu
Contact: Rebecca H Burke, MS 860-679-8478 burke@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030-2103
Contact: Yifrah Kaminer, MD, MBA     860-679-4344     kaminer@uchc.edu    
Contact: Rebecca H Burke, MS     860-679-8478     burke@uchc.edu    
Principal Investigator: Yifrah Kaminer, MD, MBA            
Sponsors and Collaborators
University of Connecticut Health Center
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Yifrah Kaminer, MD, MBA University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01656707     History of Changes
Other Study ID Numbers: PA08-263, R01DA030454
Study First Received: August 1, 2012
Last Updated: March 1, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Adolescents
Substance Use Disorders

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Behavior, Addictive
 Schizophrenia and Disorders with Psychotic Features
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on May 23, 2013