Opioid DependenceNCT02718352
A Naturalistic Study of Adolescents and Young Adults in Treatment for Opioid Dependence
An observational study of Opioid Dependence, run by Yale University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Naturalistic Prospective Cohort
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Fifty16 to 25 year old opioid treatment-seeking individuals enrolled in the APT Adolescent and Young Adult Suboxone Program.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Opioid Dependence
- Being tested
- Naturalistic Prospective Cohort
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturalistic Prospective CohortOther
Follow subjects through 1 year of naturalistic buprenorphine treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 52 weeks
Secondary outcomes (2)
Opioid Use Patterns
Urine drug screen results (opioids (and type if noted) benzodiazepines, marijuana, , cocaine, amphetamines) collected monthly from medical charts.
Measured: One year
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepa Camenga, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718352
- Sponsor's protocol ID
- 16010 17074
- Status last verified
- Jun 2018
- First submitted
- 26 Feb 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Naturalistic Study of Adolescents and Young Adults in Treatment for Opioid Dependence
- ClinicalTrials.gov ID
- NCT02718352
- Acronym / sponsor ID
- 16010 17074
- Conditions
- Opioid Dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Fifty16 to 25 year old opioid treatment-seeking individuals enrolled in the APT Adolescent and Young Adult Suboxone Program.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naturalistic Prospective CohortFollow subjects through 1 year of naturalistic buprenorphine treatment | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Opioid Use Patterns
Time frame: One year
Cigarette Use Patterns
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepa Camenga, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Dependence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use Patterns (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.