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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00680576
Other study ID # DA023568
Secondary ID R01DA023568
Status Completed
Phase Phase 1
First received May 16, 2008
Last updated October 8, 2014
Start date March 2008
Est. completion date August 2013

Study information

Verified date October 2014
Source Oregon Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out more about how to provide effective further treatment for adolescents who have received six weeks of group therapy for substance-use problems and continue to use drugs. Treatments used in the study include a group therapy (MET/CBT), an individual therapy (CBT), and a family therapy (FFT). The study will look at whether abstinence or a very low level of use is a better guide for deciding whether further treatment is needed, how well different combinations of treatment work to reduce substance use, and whether it is possible to predict in advance which adolescents will respond best to which types of treatment. Study investigators expect that a treatment strategy using what is learned about these issues in the first half of the project to develop an "adaptive" treatment model will work better than a "fixed" treatment to reduce adolescent substance use.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

1. 13 to 18 years if age

2. Meet DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence

3. Live in the Albuquerque metropolitan area or surrounding communities

4. Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).

Exclusion Criteria:

1. There is evidence of psychotic or organic state of sufficient severity to interfere with the understanding of study instruments and procedures

2. The adolescent is deemed dangerous to self or others during evaluation

3. Services other than outpatient treatment are required for the adolescent (e.g., inpatient, detoxification)

4. Marijuana use is reported as being less than 13% of days in the previous 90 days.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
CBT, Cognitive Behavioral Therapy
Eight weekly sessions of individual Cognitive Behavioral Therapy, to develop skills enabling adolescents stop or reduce their drug use.
FFT, Family Functional Therapy
Eight weekly sessions of Functional Family Therapy designed to strengthen family relationships and build skills to help the adolescent stop or reduce his/her drug use.

Locations

Country Name City State
United States Oregon Res. Inst. Center for Family & Adolescent Research (CFAR) Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urine drug screens Pretx, 6, 14 and 22 weeks, 3 and 6 months after initial treatment session No
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