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An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery

NCT03604861 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 534

Last updated 2019-04-18

No results posted yet for this study

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.

Conditions

  • Opioid-use Disorder
  • Opioid-related Disorders

Interventions

OTHER

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.

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director, Global Medicines Development · Indivior Inc.

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604861 on ClinicalTrials.gov