Mentored Clinical Career Award in Adolescent Substance Abuse - Full Text View

Purpose

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.

Condition	Intervention	Phase
Substance-Related Disorders	Other: Randomized Drug Testing Trial	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Mentored Clinical Career Award in Adolescent Substance Abuse

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

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). [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adolescent willingness to participate a in drug testing program. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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).	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).
No Intervention: 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.

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:

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.
To estimate the cost of a random drug-testing program.
To determine the factors that are associated with willingness to be tested, and barriers to enrolling adolescents in laboratory drug testing programs.
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.
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.

Eligibility

Ages Eligible for Study:	12 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622219

Locations

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Children's Hospital Boston

Investigators

Principal Investigator:

Sharon L Levy, MD, MPH

Children's Hospital Boston

More Information

Additional Information:

web site of the Center for Adolescent Substance Abuse Research at Children's Hospital Boston This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Responsible Party:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00622219 History of Changes
Other Study ID Numbers:	K23DA019570
Study First Received:	February 11, 2008
Last Updated:	January 2, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:

Alcohol abuse
Drug abuse

Additional relevant MeSH terms:

Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013