An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery (RECOVER®)

April 17, 2019 updated by: Indivior Inc.

Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study®

The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine extended-release injection (RBP-6000). The study population will consist of participants from studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003).

The RECOVER study will characterize OUD subjects' recovery process as they transition from the controlled clinical trial environment to the real world setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

534

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
    • Alabama
      • Haleyville, Alabama, United States, 35565
        • Winston Technology Research LLC
      • Hamilton, Alabama, United States, 35570
        • Boyett Health Services
    • Arkansas
      • Little Rock, Arkansas, United States
        • Woodland International Research Group
    • California
      • Glendale, California, United States
        • Behavioral Research Specialists
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Networks, Inc.
      • National City, California, United States
        • Synergy Research Center
      • Oceanside, California, United States
        • North County Clinical Research
      • San Diego, California, United States
        • Artemis Institute for Clinical Research
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Amit Vijapura
      • Lakeland, Florida, United States
        • Meridien Research
      • Maitland, Florida, United States
        • Try Research
      • Miami, Florida, United States
        • Innovative Clinical Research
      • Miami, Florida, United States
        • Scientific Clinical Research
      • Oakland Park, Florida, United States
        • Research Centers of America
    • Louisiana
      • New Orleans, Louisiana, United States
        • Louisiana Research Associates
      • Shreveport, Louisiana, United States
        • Louisiana Clinical Research
    • Massachusetts
      • Fall River, Massachusetts, United States
        • Stanley Street Treatment and Resources
      • Watertown, Massachusetts, United States, 02472
        • Adams Clinical Trials
    • Mississippi
      • Flowood, Mississippi, United States
        • Precise Research Centers, Inc.
    • Missouri
      • Saint Louis, Missouri, United States
        • St. Louis Clinical Trials
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Altea Research Institute
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
      • Cherry Hill, New Jersey, United States, 08002
        • Center for Emotional Fitness
    • New York
      • New York, New York, United States
        • The Medical Research Network, LLC
    • Ohio
      • Canton, Ohio, United States
        • Neuro-Behavioral Clinical Research
      • Dayton, Ohio, United States
        • Midwest Clinical Research Center
      • Garfield Heights, Ohio, United States
        • Charak Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Oklahoma Clinical Research Center
      • Oklahoma City, Oklahoma, United States, 73112
        • Pahl Pharmaceutical Professionals
    • Oregon
      • Portland, Oregon, United States
        • CODA
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA
      • Philadelphia, Pennsylvania, United States
        • UPenn Treatment Research Center
    • South Carolina
      • Charleston, South Carolina, United States
        • Carolina Clinical Trials
    • Texas
      • Dallas, Texas, United States, 75243
        • Pillar Clinic Research, LLC
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are currently diagnosed with moderate or severe OUD according to Diagnostic and Statistical Manual 5 (DSM-5) criteria and for 3 months immediately prior to signing the informed consent form for protocols NCT02357901 (RB-US-13-0001) and/or NCT02510014 (RB-US-13-0003).

Description

Inclusion Criteria:

  • Subjects who received at least one injection in RBP-6000 or placebo in the Phase III clinical program which includes study protocols NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) and either withdrew from or completed these studies.
  • Ability to comply with study protocol requirements for data collection and provide informed consent.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24
Time Frame: Month 24
Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).
Month 24
Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days At Months 3, 6, 9, 12, 15, 18, 21, 24
Time Frame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).
Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 28 Days At Months 3, 6, 9, 12, 15, 18, 21, 24
Time Frame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).
Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24
Time Frame: Month 24
Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.
Month 24
Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by UDS At Months 3, 6, 9, 12, 15, 18, 21, 24
Time Frame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.
Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in 12-Item Short Form Health Survey, Version 2 (SF-12v2) to Months 12 and 24
Time Frame: Baseline (Day 1), Months 12 and 24
Baseline (Day 1), Months 12 and 24
Change from Baseline in the Subjective Opioid Withdrawal Scale (SOWS) to Months 12 and 24
Time Frame: Baseline (Day 1), Months 12 and 24
Baseline (Day 1), Months 12 and 24
Change from Baseline in the Beck Depression Inventory (BDI) to Months 12 and 24
Time Frame: Baseline (Day 1), Months 12 and 24
Baseline (Day 1), Months 12 and 24
Change from Baseline in the Brief Pain Inventory (BPI) to Months 12 and 24
Time Frame: Baseline (Day 1), Months 12 and 24
Baseline (Day 1), Months 12 and 24
Percentage of Participants Currently Employed at Baseline, Month 12 and Month 24
Time Frame: Baseline (Day 1), Months 12 and 24
Baseline (Day 1), Months 12 and 24
Amount of Health Care Resource Utilization (HCRU) at Months 1-12 and Months 13-24
Time Frame: Months 1-12 and Months 13-24
HCRU information includes hospitalizations, residential substance abuse treatment, general practitioner/specialist/and counseling visits, and emergency department (ED) visits.
Months 1-12 and Months 13-24
Number of Crimes Committed at Baseline, Months 1-12 and Months 13-24
Time Frame: Baseline (Months -6 to Day 1), Months 1-12 and Months 13-24
Participants complete surveys to identify the number and type of criminal incidents in a given time frame. These questions include information on arrests, violence, unlawful behaviors, and driver's license status.
Baseline (Months -6 to Day 1), Months 1-12 and Months 13-24

Collaborators and Investigators

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

Sponsor

Indivior Inc.

Investigators

  • Study Chair: Study Director, Global Medicines Development, Indivior Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INDV-6000-N01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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