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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00680511
Other study ID # DA021695
Secondary ID
Status Completed
Phase Phase 1
First received May 16, 2008
Last updated August 4, 2014
Start date September 2007
Est. completion date December 2013

Study information

Verified date August 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 AIMS study compares a methamphetamine-specific treatment intervention to a treatment-as-usual Functional Family Therapy (FFT) approach for adolescents ages 15 to 19. Adolescents are assigned to one of two treatment conditions: (1) 16 weeks of FFT designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use; or (2) 16 weeks of a combination of FFT and a methamphetamine-specific intervention involving group and individual therapy sessions; Families are assessed using questionnaires and interviews, and adolescents participate in neuropsychological testing, before, during, and after treatment to provide information about family functioning, the adolescent's drug use, the adolescent's peers, and other factors that may contribute to treatment success. Adolescents also provide urine specimens for drug screening at assessment visits. Through a partnership with Oregon Health and Science University (OHSU), adolescents will participate in functional magnetic resonance imaging appointments at the hospital to examine regional brain blood flow during tasks designed to measure impulsivity and risk-taking behaviors. As a treatment development grant, study investigators will study adolescents' acceptance of and response to the newly developed methamphetamine-specific treatment approach.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 19 Years
Eligibility Inclusion Criteria:

- 15 to 19 years of age.

- Have at least one parent or parent figure willing to participate.

- Meet DSM-IV diagnostic criteria for drug-abuse or dependence, including a specific meth use disorder.

- Reports meth use on at least 5 of the previous 90 days.

- Have contact with the parent on at least 40% of the past 90 days.

- With their parent be willing to accept randomization to one of the two treatment interventions.

- Be willing to participate in the imaging task in the fMRI pilot study.

- Have basic English competency.

- Have sufficient residential stability to permit probable contact at follow-up.

Exclusion Criteria:

- Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures.

- Have a medical or psychological condition that would preclude undergoing the fMRI scan.

- Have a sibling who is participating in the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Adolescent Methamphetamine Treament (AMT)
AMT Group Therapy plus Functional Family Therapy (FFT)
Functional Family Therapy (FFT)
FFT

Locations

Country Name City State
United States Oregon Research Institute Center for Family and Adolescent Research Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Research Institute National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Substance Use 6 months No
Secondary Engagement and retention of adolescent methamphetamine users. 6 months No

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