An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery

Completed

• Conditions: Opioid-related Disorders; Opioid-use Disorder

• Registration Number: NCT03604861
• Lead Sponsor: Indivior Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-30
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24	Month 24	Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).
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	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).
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	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).
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	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.
Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24	Month 24	Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.

Trial Locations

Locations (35)

Woodland International Research Group; 🇺🇸 Little Rock, Arkansas, United States

Center for Emotional Fitness; 🇺🇸 Cherry Hill, New Jersey, United States

Carolina Clinical Trials; 🇺🇸 Charleston, South Carolina, United States

Pillar Clinic Research, LLC; 🇺🇸 Dallas, Texas, United States

Collaborative Neuroscience Networks, Inc.; 🇺🇸 Long Beach, California, United States

Synergy Research Center; 🇺🇸 National City, California, United States

North County Clinical Research; 🇺🇸 Oceanside, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Amit Vijapura; 🇺🇸 Jacksonville, Florida, United States

Scientific Clinical Research; 🇺🇸 Miami, Florida, United States

Research Centers of America; 🇺🇸 Oakland Park, Florida, United States

UPenn Treatment Research Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA; 🇺🇸 Altoona, Pennsylvania, United States

InSite Clinical Research; 🇺🇸 DeSoto, Texas, United States

Winston Technology Research LLC; 🇺🇸 Haleyville, Alabama, United States

Boyett Health Services; 🇺🇸 Hamilton, Alabama, United States

Behavioral Research Specialists; 🇺🇸 Glendale, California, United States

Try Research; 🇺🇸 Maitland, Florida, United States

Meridien Research; 🇺🇸 Lakeland, Florida, United States

Innovative Clinical Research; 🇺🇸 Miami, Florida, United States

Louisiana Research Associates; 🇺🇸 New Orleans, Louisiana, United States

Louisiana Clinical Research; 🇺🇸 Shreveport, Louisiana, United States

Stanley Street Treatment and Resources; 🇺🇸 Fall River, Massachusetts, United States

Adams Clinical Trials; 🇺🇸 Watertown, Massachusetts, United States

Precise Research Centers, Inc.; 🇺🇸 Flowood, Mississippi, United States

St. Louis Clinical Trials; 🇺🇸 Saint Louis, Missouri, United States

Altea Research Institute; 🇺🇸 Las Vegas, Nevada, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

Neuro-behavioral Clinical Research; 🇺🇸 Canton, Ohio, United States

The Medical Research Network, LLC; 🇺🇸 New York, New York, United States

Midwest Clinical Research Center; 🇺🇸 Dayton, Ohio, United States

Charak Clinical Research Center; 🇺🇸 Garfield Heights, Ohio, United States

Pahl Pharmaceutical Professionals; 🇺🇸 Oklahoma City, Oklahoma, United States

Oklahoma Clinical Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States

CODA; 🇺🇸 Portland, Oregon, United States