An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery (RECOVER®)
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| ClinicalTrials.gov Identifier: NCT03604861 |
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Recruitment Status :
Completed
First Posted : July 30, 2018
Last Update Posted : April 18, 2019
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Sponsor:
Indivior Inc.
Information provided by (Responsible Party):
Indivior Inc.
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Opioid-use Disorder Opioid-related Disorders | Other: Not applicable - no defined intervention |
| Study Type : | Observational |
| Actual Enrollment : | 534 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study® |
| Actual Study Start Date : | August 2015 |
| Actual Primary Completion Date : | March 2019 |
| Actual Study Completion Date : | March 2019 |
Resource links provided by the National Library of Medicine
Intervention Details:
- 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.
Primary Outcome Measures :
- Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24 [ Time Frame: Month 24 ]Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).
- 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 [ Time Frame: Baseline (Day 1), 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).
- 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 [ Time Frame: Baseline (Day 1), 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).
- Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24 [ Time Frame: Month 24 ]Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.
- 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 [ Time Frame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24 ]Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.
Other Outcome Measures:
- Change from Baseline in 12-Item Short Form Health Survey, Version 2 (SF-12v2) to Months 12 and 24 [ Time Frame: Baseline (Day 1), Months 12 and 24 ]
- Change from Baseline in the Subjective Opioid Withdrawal Scale (SOWS) to Months 12 and 24 [ Time Frame: Baseline (Day 1), Months 12 and 24 ]
- Change from Baseline in the Beck Depression Inventory (BDI) to Months 12 and 24 [ Time Frame: Baseline (Day 1), Months 12 and 24 ]
- Change from Baseline in the Brief Pain Inventory (BPI) to Months 12 and 24 [ Time Frame: Baseline (Day 1), Months 12 and 24 ]
- Percentage of Participants Currently Employed at Baseline, Month 12 and Month 24 [ Time Frame: Baseline (Day 1), Months 12 and 24 ]
- Amount of Health Care Resource Utilization (HCRU) at Months 1-12 and Months 13-24 [ Time Frame: 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.
- Number of Crimes Committed at Baseline, Months 1-12 and Months 13-24 [ Time Frame: Baseline (Months -6 to Day 1), 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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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).
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604861
Locations
Show 35 study locations
Sponsors and Collaborators
Indivior Inc.
Investigators
| Study Chair: | Study Director, Global Medicines Development | Indivior Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Indivior Inc. |
| ClinicalTrials.gov Identifier: | NCT03604861 |
| Other Study ID Numbers: |
INDV-6000-N01 |
| First Posted: | July 30, 2018 Key Record Dates |
| Last Update Posted: | April 18, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Indivior Inc.:
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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 |
Additional relevant MeSH terms:
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Disease Opioid-Related Disorders Pathologic Processes Narcotic-Related Disorders |
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |