Mentored Clinical Career Award in Adolescent Substance Abuse

NCT ID: NCT00622219

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2013-08-31

Brief Summary

The goal of this project is to determine the barriers to, and risks and benefits of random laboratory drug testing for adolescents with identified drug or alcohol problems.

Detailed Description

Use of drugs and alcohol is associated with a variety of health care problems, making settings where adolescents receive routine medical care ideal for implementation of routine screening and early intervention. However, little research has been conducted on the efficacy of interventions for adolescent primary care patients who are using drugs or alcohol. Urine drug testing can be used for a variety of indications, including school or work based population surveillance, verification of history, or monitoring of individuals who are in treatment for a drug-use disorder. This study will focus exclusively on the therapeutic use of urine drug testing. Drug testing can be a useful therapeutic adjuvant for patients with drug-use disorders in a variety of settings.

This study will investigate the use of random laboratory drug testing as a therapeutic intervention for teens with drug problem use, abuse or dependence. We have 5 objectives:

1. To develop a standardized protocol for random urine drug testing, produce a manual and training protocol, and refine the protocol in preparation for a future efficacy trial.

2. To estimate the cost of a random drug-testing program.

3. To determine the factors that are associated with willingness to be tested, and barriers to enrolling adolescents in laboratory drug testing programs.

4. To perform an initial, small-scale experimental trial of the random drug testing protocol. The purpose of this trial is to estimate the effect size of the intervention and will be used in calculating the sample size for a future stage 1b trial.

5. To determine the potential risks to adolescents who participate in a random drug testing program, including possible breach of confidentiality, greater conflict between the parent and child, more difficulty with communication between clinician and patient, increased use of drugs not detected by routine urine screens (i.e. inhalants), and increased use of strategies and products known to defeat drug tests.

Conditions

Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Drug Testing

Adolescents in the experimental condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated)and will be enrolled in a random drug testing program (with an average of 12 requests for testing over a 12 week period).

Group Type: EXPERIMENTAL

Randomized Drug Testing Trial

Intervention Type: OTHER

Adolescents in the experimental condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated)and will be enrolled in a random drug testing program (with an average of 12 requests for testing over a 12 week period).

Control

Adolescents randomized to the control condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated) but will not be called for drug tests.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Randomized Drug Testing Trial

Adolescents in the experimental condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated)and will be enrolled in a random drug testing program (with an average of 12 requests for testing over a 12 week period).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adolescents ages 12-21
• Participants must have use of alcohol, cannabis, or another substance on at least 2 occasions in the 30 days preceding their initial assessment or 6 or more times in the past 90 days
• Participants must have health insurance or be willing to pay for the laboratory costs associated with drug testing.
• Participants must provide informed assent and, for those under 18, parental consent.

Exclusion Criteria

• Participants who require immediate hospitalization or immediate referral to residential substance abuse treatment
• Participants who cannot understand or read English at a 6th grade reading level
• Participants who are enrolled in the ASAP buprenorphine program
• Participants who report previous use of inhalants or any other substance that is not easily detected with urine drug testing

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sharon Levy

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon L Levy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Children's Hospital Boston

Boston, Massachusetts, United States

Countries

United States

References

Levy S, Harris SK, Sherritt L, Angulo M, Knight JR. Drug testing of adolescents in ambulatory medicine: physician practices and knowledge. Arch Pediatr Adolesc Med. 2006 Feb;160(2):146-50. doi: 10.1001/archpedi.160.2.146.

Reference Type: BACKGROUND

PMID: 16461869 (View on PubMed)

Levy S, Harris SK, Sherritt L, Angulo M, Knight JR. Drug testing of adolescents in general medical clinics, in school and at home: physician attitudes and practices. J Adolesc Health. 2006 Apr;38(4):336-42. doi: 10.1016/j.jadohealth.2005.11.023.

Reference Type: BACKGROUND

PMID: 16549293 (View on PubMed)

Related Links

http://www.ceasar.org

web site of the Center for Adolescent Substance Abuse Research at Children's Hospital Boston

Other Identifiers

K23DA019570

Identifier Type: NIH

Identifier Source: org_study_id

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