An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery

NCT ID: NCT03604861

Last Updated: 2019-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

534 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-03-31

Brief Summary

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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

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Conditions

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Opioid-use Disorder Opioid-related Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Not applicable - no defined intervention

Participants who received at least one injection of RBP-6000 or placebo and either withdrew from or completed the Phase III clinical program which included studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) were eligible for the RECOVER Study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indivior Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director, Global Medicines Development

Role: STUDY_CHAIR

Indivior Inc.

Locations

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Winston Technology Research LLC

Haleyville, Alabama, United States

Site Status

Boyett Health Services

Hamilton, Alabama, United States

Site Status

Woodland International Research Group

Little Rock, Arkansas, United States

Site Status

Behavioral Research Specialists

Glendale, California, United States

Site Status

Collaborative Neuroscience Networks, Inc.

Long Beach, California, United States

Site Status

Synergy Research Center

National City, California, United States

Site Status

North County Clinical Research

Oceanside, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

Amit Vijapura

Jacksonville, Florida, United States

Site Status

Meridien Research

Lakeland, Florida, United States

Site Status

Try Research

Maitland, Florida, United States

Site Status

Innovative Clinical Research

Miami, Florida, United States

Site Status

Scientific Clinical Research

Miami, Florida, United States

Site Status

Research Centers of America

Oakland Park, Florida, United States

Site Status

Louisiana Research Associates

New Orleans, Louisiana, United States

Site Status

Louisiana Clinical Research

Shreveport, Louisiana, United States

Site Status

Stanley Street Treatment and Resources

Fall River, Massachusetts, United States

Site Status

Adams Clinical Trials

Watertown, Massachusetts, United States

Site Status

Precise Research Centers, Inc.

Flowood, Mississippi, United States

Site Status

St. Louis Clinical Trials

St Louis, Missouri, United States

Site Status

Altea Research Institute

Las Vegas, Nevada, United States

Site Status

Hassman Research Institute

Berlin, New Jersey, United States

Site Status

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Site Status

The Medical Research Network, LLC

New York, New York, United States

Site Status

Neuro-behavioral Clinical Research

Canton, Ohio, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

Charak Clinical Research Center

Garfield Heights, Ohio, United States

Site Status

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, United States

Site Status

Pahl Pharmaceutical Professionals

Oklahoma City, Oklahoma, United States

Site Status

CODA

Portland, Oregon, United States

Site Status

Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA

Altoona, Pennsylvania, United States

Site Status

UPenn Treatment Research Center

Philadelphia, Pennsylvania, United States

Site Status

Carolina Clinical Trials

Charleston, South Carolina, United States

Site Status

Pillar Clinic Research, LLC

Dallas, Texas, United States

Site Status

InSite Clinical Research

DeSoto, Texas, United States

Site Status

Countries

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United States

References

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Craft WH, Tegge AN, Keith DR, Shin H, Williams J, Athamneh LN, Stein JS, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug Alcohol Depend. 2022 May 1;234:109389. doi: 10.1016/j.drugalcdep.2022.109389. Epub 2022 Mar 9.

Reference Type DERIVED
PMID: 35287034 (View on PubMed)

Ling W, Nadipelli VR, Aldridge AP, Ronquest NA, Solem CT, Chilcoat H, Albright V, Johnson C, Learned SM, Mehra V, Heidbreder C. Recovery From Opioid Use Disorder (OUD) After Monthly Long-acting Buprenorphine Treatment: 12-Month Longitudinal Outcomes From RECOVER, an Observational Study. J Addict Med. 2020 Sep/Oct;14(5):e233-e240. doi: 10.1097/ADM.0000000000000647.

Reference Type DERIVED
PMID: 32187112 (View on PubMed)

Other Identifiers

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INDV-6000-N01

Identifier Type: -

Identifier Source: org_study_id

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