Mentored Clinical Career Award in Adolescent Substance Abuse

Substance-Related Disorders Clinical Trial

Official title:

Mentored Clinical Career Award in Adolescent Substance Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622219
• Other study ID #: K23DA019570
• Status: Completed
• Phase: N/A
• First received: February 11, 2008
• Last updated: June 19, 2017
• Start date: March 2008
• Est. completion date: August 31, 2013

Study information

• Verified date: June 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 31, 2013
• Est. primary completion date: August 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adolescent willingness to participate a in drug testing program.		90 days

External Links

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