Opioid-use DisorderRECOVER®NCT03604861
An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery
An observational study of Opioid-use Disorder and Opioid-related Disorders, run by Indivior Inc. at 35 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder, Opioid-related Disorders
- What is being tested?
- Not applicable - no defined intervention
- Type of treatment
- Injection or infusion
- How many people
- 534 participants
- Where
- 35 sitesUnited States
- Study dates
- Aug 2015to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA
Altoona, Pennsylvania
Hassman Research Institute
Berlin, New Jersey, 08009
Neuro-behavioral Clinical Research
Canton, Ohio
Carolina Clinical Trials
Charleston, South Carolina
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Pillar Clinic Research, LLC
Dallas, Texas, 75243
Midwest Clinical Research Center
Dayton, Ohio
InSite Clinical Research
DeSoto, Texas, 75115
Stanley Street Treatment and Resources
Fall River, Massachusetts
Precise Research Centers, Inc.
Flowood, Mississippi
Charak Clinical Research Center
Garfield Heights, Ohio
Behavioral Research Specialists
Glendale, California
Winston Technology Research LLC
Haleyville, Alabama, 35565
Boyett Health Services
Hamilton, Alabama, 35570
Amit Vijapura
Jacksonville, Florida, 32256
Meridien Research
Lakeland, Florida
Altea Research Institute
Las Vegas, Nevada, 89102
Woodland International Research Group
Little Rock, Arkansas
Collaborative Neuroscience Networks, Inc.
Long Beach, California, 90806
Try Research
Maitland, Florida
Innovative Clinical Research
Miami, Florida
Scientific Clinical Research
Miami, Florida
Synergy Research Center
National City, California
Louisiana Research Associates
New Orleans, Louisiana
The Medical Research Network, LLC
New York, New York
Research Centers of America
Oakland Park, Florida
North County Clinical Research
Oceanside, California
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, 73112
Pahl Pharmaceutical Professionals
Oklahoma City, Oklahoma, 73112
UPenn Treatment Research Center
Philadelphia, Pennsylvania
CODA
Portland, Oregon
Artemis Institute for Clinical Research
San Diego, California
Louisiana Clinical Research
Shreveport, Louisiana
St. Louis Clinical Trials
St Louis, Missouri
Adams Clinical Trials
Watertown, Massachusetts, 02472
About this study
Official title: Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study®
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.
- Conditions
- Opioid-use Disorder, Opioid-related Disorders
- Being tested
- Not applicable - no defined intervention
- 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
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Heroin Dependence, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable - no defined interventionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study startAug 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Global Medicines Development, Study chair, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604861
- Sponsor's protocol ID
- INDV-6000-N01
- Acronym
- RECOVER®
- Status last verified
- Apr 2019
- First submitted
- 9 Jul 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35287034Ling 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.
PubMed 32187112
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study®
- ClinicalTrials.gov ID
- NCT03604861
- Acronym / sponsor ID
- RECOVER® / INDV-6000-N01
- Conditions
- Opioid-use Disorder, Opioid-related Disorders
- Keywords
- Opioid recovery, Recovery, Opioid-related disorders, Substance-related disorders, Heroin dependence, Opioid dependence, Addiction, Buprenorphine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable - no defined interventionParticipants 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 35287034Craft 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.
- Derived from this study: PubMed 32187112Ling 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director, Global Medicines Development study chair
Indivior Inc.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder and Opioid-related Disorders, run by Indivior Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24 (time frame: Month 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604861, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.