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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03604861
Other study ID # INDV-6000-N01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2015
Est. completion date March 2019

Study information

Verified date April 2019
Source Indivior Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 534
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Indivior Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from Baseline in 12-Item Short Form Health Survey, Version 2 (SF-12v2) to Months 12 and 24 Baseline (Day 1), Months 12 and 24
Other Change from Baseline in the Subjective Opioid Withdrawal Scale (SOWS) to Months 12 and 24 Baseline (Day 1), Months 12 and 24
Other Change from Baseline in the Beck Depression Inventory (BDI) to Months 12 and 24 Baseline (Day 1), Months 12 and 24
Other Change from Baseline in the Brief Pain Inventory (BPI) to Months 12 and 24 Baseline (Day 1), Months 12 and 24
Other Percentage of Participants Currently Employed at Baseline, Month 12 and Month 24 Baseline (Day 1), Months 12 and 24
Other Amount of Health Care Resource Utilization (HCRU) at 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
Other Number of Crimes Committed at Baseline, 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
Primary Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24 Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH). Month 24
Primary 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 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
Primary 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 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
Primary Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24 Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS. Month 24
Primary 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 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
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