An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery

Opioid-related Disorders Clinical Trial

— RECOVER®  

Official title:

Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery—The RECOVER Study®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604861
• Other study ID #: INDV-6000-N01
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Disease
• Opioid-Related Disorders
• Opioid-use Disorder

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