A Naturalistic Study of Adolescents and Young Adults in Treatment for Opioid Dependence

Completed

• Conditions: Opioid Dependence

• Registration Number: NCT02718352
• Lead Sponsor: Yale University

Brief Summary

Many buprenorphine treatment programs do not have services dedicated to adolescents and young adults. As a precursor to developing and evaluating an adolescent and young adult buprenorphine treatment program at APT Foundation Inc, we propose to conduct a 1 year prospective study of 16 to 25 year old treatment-seeking individuals enrolled in the APT Adolescent and Young Adult Suboxone Program

Detailed Description

Participants will consent to in-person assessments and monthly chart reviews. We anticipate that the results from this study will inform the development of future services targeted towards adolescents and young adults with opioid dependence.

Study Timeline

• Study First Submitted: 2016-02-26
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-24
• Primary Completion: 2018-02
• Study Completion: 2018-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Ages 16 through 25 at time of induction
• Meet criteria for enrollment in the APT Adolescent and Young Adult Suboxone Program (Opioid Dependence per DSM-V criteria; no contraindications to buprenorphine (concomitant benzodiazepine, alcohol use, sedative use),
• Stable enough to participate in outpatient care/intensive outpatient care for at least 12 weeks;
• Can commit to at least 12 weeks of treatment through the APT Adolescent and Young Adult Suboxone Program
• Are willing to provide locator information for follow-up.
• Are fluent in English and have a 6th grader or higher reading level

Read More

Exclusion Criteria

• Have an untreated bipolar or schizophrenic disorder, or active suicidal ideation
• Are physically dependent on alcohol, benzodiazepines, or other sedatives.
• Are in custody of the Department of Children and Families

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Opioid Use Patterns	52 weeks	To describe the progression of opioid use among adolescents and young adults participating in buprenorphine treatment, the subjects will fill out time line follow back surveys to describe opioid use patterns.

Secondary Outcome Measures

Name	Time	Method
Opioid Use Patterns	One year	Urine drug screen results (opioids (and type if noted) benzodiazepines, marijuana, , cocaine, amphetamines) collected monthly from medical charts.
Cigarette Use Patterns	One year	To describe the progression of cigarette use among adolescents and young adults participating in buprenorphine treatment, the subjects will fill out time line follow back surveys to describe cigarette use patterns.

Trial Locations

Locations (1)

APT Foundation; 🇺🇸 New Haven, Connecticut, United States