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Completed

NCT Number: NCT02718352

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

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

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Key information

Conditions

Opioid Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

APT Foundation

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naturalistic Prospective Cohort

Other

Follow subjects through 1 year of naturalistic buprenorphine treatment

Primary outcomes

  1. Opioid Use Patterns

    Time frame: baseline

    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.

  2. Opioid Use Patterns

    Time frame: 4 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.

  3. Opioid Use Patterns

    Time frame: 8 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.

  4. Opioid Use Patterns

    Time frame: 12 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.

  5. Opioid Use Patterns

    Time frame: 24 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.

  6. Opioid Use Patterns

    Time frame: 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 outcomes

  1. Opioid Use Patterns

    Time frame: One year

    Urine drug screen results (opioids (and type if noted) benzodiazepines, marijuana, , cocaine, amphetamines) collected monthly from medical charts.

  2. Cigarette Use Patterns

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2016
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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