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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable - no defined intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Change from Baseline in the Subjective Opioid Withdrawal Scale (SOWS) to Months 12 and 24 | Baseline (Day 1), Months 12 and 24 |
Inclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Study Director, Global Medicines Development | Indivior Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winston Technology Research LLC | Haleyville | Alabama | 35565 | United States | ||
| Boyett Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35287034 | Derived | 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. | |
| 32187112 | Derived |
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| Change from Baseline in the Beck Depression Inventory (BDI) to Months 12 and 24 | Baseline (Day 1), Months 12 and 24 |
| Change from Baseline in the Brief Pain Inventory (BPI) to Months 12 and 24 | Baseline (Day 1), Months 12 and 24 |
| Percentage of Participants Currently Employed at Baseline, Month 12 and Month 24 | Baseline (Day 1), Months 12 and 24 |
| 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 |
| 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 |
| Hamilton |
| Alabama |
| 35570 |
| United States |
| Woodland International Research Group | Little Rock | Arkansas | United States |
| Behavioral Research Specialists | Glendale | California | United States |
| Collaborative Neuroscience Networks, Inc. | Long Beach | California | 90806 | United States |
| Synergy Research Center | National City | California | United States |
| North County Clinical Research | Oceanside | California | United States |
| Artemis Institute for Clinical Research | San Diego | California | United States |
| Amit Vijapura | Jacksonville | Florida | 32256 | United States |
| Meridien Research | Lakeland | Florida | United States |
| Try Research | Maitland | Florida | United States |
| Innovative Clinical Research | Miami | Florida | United States |
| Scientific Clinical Research | Miami | Florida | United States |
| Research Centers of America | Oakland Park | Florida | United States |
| Louisiana Research Associates | New Orleans | Louisiana | United States |
| Louisiana Clinical Research | Shreveport | Louisiana | United States |
| Stanley Street Treatment and Resources | Fall River | Massachusetts | United States |
| Adams Clinical Trials | Watertown | Massachusetts | 02472 | United States |
| Precise Research Centers, Inc. | Flowood | Mississippi | United States |
| St. Louis Clinical Trials | St Louis | Missouri | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| The Medical Research Network, LLC | New York | New York | United States |
| Neuro-behavioral Clinical Research | Canton | Ohio | United States |
| Midwest Clinical Research Center | Dayton | Ohio | United States |
| Charak Clinical Research Center | Garfield Heights | Ohio | United States |
| Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | United States |
| Pahl Pharmaceutical Professionals | Oklahoma City | Oklahoma | 73112 | United States |
| CODA | Portland | Oregon | United States |
| Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA | Altoona | Pennsylvania | United States |
| UPenn Treatment Research Center | Philadelphia | Pennsylvania | United States |
| Carolina Clinical Trials | Charleston | South Carolina | United States |
| Pillar Clinic Research, LLC | Dallas | Texas | 75243 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| 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. |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| D006556 | Heroin Dependence |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
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