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

Opioid Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718352
• Other study ID #: 16010 17074
• Status: Completed
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: June 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Other:
• Naturalistic Prospective Cohort
Follow subjects through 1 year of naturalistic buprenorphine treatment

Locations

Country	Name	City	State
United States	APT Foundation	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use Patterns	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.	baseline
Primary	Opioid Use Patterns	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.	4 weeks
Primary	Opioid Use Patterns	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.	8 weeks
Primary	Opioid Use Patterns	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.	12 weeks
Primary	Opioid Use Patterns	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.	24 weeks
Primary	Opioid Use Patterns	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.	52 weeks
Secondary	Opioid Use Patterns	Urine drug screen results (opioids (and type if noted) benzodiazepines, marijuana, , cocaine, amphetamines) collected monthly from medical charts.	One year
Secondary	Cigarette Use Patterns	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.	One year