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

Indivior

Status: Completed

Conditions: Opioid-use Disorder; Opioid-related Disorders

Treatments: Other: Not applicable - no defined intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03604861

INDV-6000-N01

Details and patient eligibility

About

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.

Enrollment: 534 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.