Mentored Clinical Career Award in Adolescent Substance Abuse

Not Applicable

Completed

• Conditions: Substance-Related Disorders
• Interventions: Other: Randomized Drug Testing Trial

• Registration Number: NCT00622219
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-22
• Study Start: 2008-03
• Primary Completion: 2013-08-31
• Study Completion: 2013-08-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Testing	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).

Primary Outcome Measures

Name	Time	Method
Percentage days abstinent from any substance use during the past 90 days, as measured by self-report via a Time Line Follow Back calendar (TLFB).	90 days

Secondary Outcome Measures

Name	Time	Method
Adolescent willingness to participate a in drug testing program.	90 days

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States