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

June 26, 2018 updated by: Yale University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • APT Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
4 weeks
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.
8 weeks
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.
12 weeks
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.
24 weeks
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.
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
One year
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deepa Camenga, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16010 17074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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