NCT02718352

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

February 26, 2016

Last Update Submit

June 26, 2018

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Opioid Use Patterns

    One year

  • Cigarette Use Patterns

    One year

Interventions

Naturalistic Prospective CohortOTHER

Follow subjects through 1 year of naturalistic buprenorphine treatment

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Fifty16 to 25 year old opioid treatment-seeking individuals enrolled in the APT Adolescent and Young Adult Suboxone Program.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APT Foundation

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Deepa Camenga, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 24, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)