TAU Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With CTN-0051

March 17, 2020 updated by: NYU Langone Health

Treatment-as-Usual (TAU) Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With National Institute on Drug Abuse (NIDA) CTN-0051

This is an observational, "ancillary study" intended to describe opioid use among opioid use disorder patients following their discharge into the community from inpatient detoxification and/or short-term residential treatment programs affiliated with parent study CTN-0051, which assessed the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.

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

Participant recruitment will begin after recruitment for CTN-0051 has been completed. Opioid use disorder patients will be recruited prior to leaving detoxification and/or short-term residential programs. Screening and baseline data (focused on demographics, diagnosis and service utilization) will be collected prior to discharge, and follow-up data (focused on opioid use) will be collected at weeks 1, 4 and 8 following discharge.

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.
211

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
    • California
      • Tarzana, California, United States, 91356
        • Tarzana Treatment Centers
    • Florida
      • Jacksonville, Florida, United States, 32201
        • Gateway Community Services, Inc.
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Stanley Street Treatment and Resources
    • New York
      • New York, New York, United States, 10016
        • Bellevue Hospital
    • Ohio
      • Columbus, Ohio, United States, 43207
        • Maryhaven

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be a convenience sample of up to three hundred sixty (360) opioid dependent patients leaving detoxification or short-term residential units at sites participating in CTN-0051. Up to 60 participants will be recruited at each of approximately six sites.

Description

Inclusion Criteria:

  • 18 years or older;
  • Meet DSM-5 criteria for opioid-use disorder (heroin or prescription opioids);
  • Have used opioids other than as specifically prescribed within thirty days prior to consent
  • Seeking treatment for opioid dependence;
  • Able to provide written informed consent;
  • Able to speak English sufficiently to understand the study procedures.

Exclusion Criteria:

  • Serious medical, psychiatric or substance use disorder that, in the opinion of the Site PI, would make participation hazardous to the participant, compromise study findings or prevent the participant from completing the study;
  • Suicidal or homicidal ideation that requires immediate attention;
  • Maintenance on methadone at doses of 30mg or greater at the time of signing consent;
  • Presence of pain of sufficient severity as to require ongoing pain management with opioids;
  • Pending legal action or other reasons that might prevent an individual from completing the study;
  • If female, currently pregnant or breastfeeding or planning on conception;
  • Prior participation in parent trial CTN-0051

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Opioid Use Disorder Patients
Other: Treatment As Usual

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
Days of Opioid Use
Time Frame: Up to Week 4 Post Discharge
Days of use during the first 4 weeks post discharge
Up to Week 4 Post Discharge
Positive Urine Drug Screen (UDS) at Week 1
Time Frame: week 1
Number of positive UDSs at Week 1
week 1
Negative UDSs at Week 1
Time Frame: week 1
Number of negative UDSs at Week 1
week 1
Missing UDSs at Week 1
Time Frame: week 1
Number of missing UDSs at Week 1
week 1
Missing UDSs at Week 4
Time Frame: week 4
Number of missing UDSs at Week 4
week 4
Positive UDSs at Week 4
Time Frame: week 4
Number of positive UDSs at Week 4
week 4
Negative UDSs at Week 4
Time Frame: week 4
Number of negative UDSs at Week 4
week 4
Missing UDSs at Week 8
Time Frame: week 8
Number of missing UDSs at Week 8
week 8
Negative UDSs at Week 8
Time Frame: week 8
Number of negative UDSs at Week 8
week 8
Positive UDSs at Week 8
Time Frame: week 8
Number of positive UDSs at Week 8
week 8
Time to First Use
Time Frame: Up to Week 8 Post Discharge
Days to first opioid use from Timeline Followback
Up to Week 8 Post Discharge
Time to Regular Use
Time Frame: Up to Week 8 Post Discharge
Days to regular opioid use from Timeline Followback
Up to Week 8 Post Discharge
Days of Opioid Use
Time Frame: Up to Week 8 Post Discharge
Days of use up 8 weeks post discharge
Up to Week 8 Post Discharge

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.
NYU Langone Health

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: John Rotrosen, MD, New York University Medical School

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.
June 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.
January 30, 2017

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.
January 30, 2017

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).
March 21, 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 31, 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.
April 6, 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.
March 27, 2020

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.
March 17, 2020

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.
March 1, 2020

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.
  • 16-00090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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