- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02718352
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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
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
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
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
Investigators
- 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)
March 1, 2016
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
February 26, 2016
First Submitted That Met QC Criteria
March 23, 2016
First Posted (Estimate)
March 24, 2016
Study Record Updates
Last Update Posted (Actual)
June 27, 2018
Last Update Submitted That Met QC Criteria
June 26, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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