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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01656707
Other study ID # PA08-263
Secondary ID R01DA030454
Status Completed
Phase N/A
First received August 1, 2012
Last updated April 10, 2017
Start date September 2011
Est. completion date July 2016

Study information

Verified date April 2017
Source UConn Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 172
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility 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

Study Design


Intervention

Behavioral:
ACRA
Ten weekly,60-minute therapy sessions including six individual, two parent/guardian and two joint (individual and parent/guardian).
CBT
10 weekly, 60-minute sessions of augmented individualized CBT

Locations

Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (2)

Lead Sponsor Collaborator
UConn Health National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Each participant will serve as his/her own control. The outcomes will include the T-ASI, T-ASI-P, and drug urinalyses. one year
Secondary 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. The secondary outcome measures will include the SCQ, CRI, PRQ, and SSQ. one year
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