Clinical trial NCT03604861: An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery
Official title: Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Opioid-related Disorders
Keywords: Opioid recovery
Recovery
Opioid-related disorders
Substance-related disorders
Heroin dependence
Opioid dependence
Addiction
Buprenorphine
Opiate substitution treatment
Analgesics
Opioid
Narcotics
Patient outcome assessment
Patient-centered care
Cost of illness
Employment
Health-related quality-of-life
Family relations
Lifestyle
Citizenship
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are currently diagnosed with moderate or severe OUD according to Diagnostic and Statistical Manual 5 (DSM-5) criteria and for 3 months immediately prior to signing the informed consent form for protocols NCT02357901 (RB-US-13-0001) and/or NCT02510014 (RB-US-13-0003).

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24
timeFrame: Month 24
measure: 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
timeFrame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
measure: 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
timeFrame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
measure: Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24
timeFrame: Month 24
measure: 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
timeFrame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Secondary outcomes:
Other outcomes:
measure: Change from Baseline in 12-Item Short Form Health Survey, Version 2 (SF-12v2) to Months 12 and 24
timeFrame: Baseline (Day 1), Months 12 and 24
measure: Change from Baseline in the Subjective Opioid Withdrawal Scale (SOWS) to Months 12 and 24
timeFrame: Baseline (Day 1), Months 12 and 24
measure: Change from Baseline in the Beck Depression Inventory (BDI) to Months 12 and 24
timeFrame: Baseline (Day 1), Months 12 and 24
measure: Change from Baseline in the Brief Pain Inventory (BPI) to Months 12 and 24
timeFrame: Baseline (Day 1), Months 12 and 24
measure: Percentage of Participants Currently Employed at Baseline, Month 12 and Month 24
timeFrame: Baseline (Day 1), Months 12 and 24
measure: Amount of Health Care Resource Utilization (HCRU) at Months 1-12 and Months 13-24
timeFrame: Months 1-12 and Months 13-24
measure: Number of Crimes Committed at Baseline, Months 1-12 and Months 13-24
timeFrame: Baseline (Months -6 to Day 1), Months 1-12 and Months 13-24
Locations:
city: Haleyville
country: United States
facility: Winston Technology Research LLC
state: Alabama
city: Hamilton
country: United States
facility: Boyett Health Services
state: Alabama
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Glendale
country: United States
facility: Behavioral Research Specialists
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Networks, Inc.
state: California
city: National City
country: United States
facility: Synergy Research Center
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Jacksonville
country: United States
facility: Amit Vijapura
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Maitland
country: United States
facility: Try Research
state: Florida
city: Miami
country: United States
facility: Innovative Clinical Research
state: Florida
city: Miami
country: United States
facility: Scientific Clinical Research
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America
state: Florida
city: New Orleans
country: United States
facility: Louisiana Research Associates
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Clinical Research
state: Louisiana
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical Trials
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers, Inc.
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Canton
country: United States
facility: Neuro-behavioral Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Garfield Heights
country: United States
facility: Charak Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Professionals
state: Oklahoma
city: Portland
country: United States
facility: CODA
state: Oregon
city: Altoona
country: United States
facility: Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: UPenn Treatment Research Center
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials
state: South Carolina
city: Dallas
country: United States
facility: Pillar Clinic Research, LLC
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
Study officials:
affiliation: Indivior Inc.
name: Study Director, Global Medicines Development
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.