24 Apr RECOVER Study: Recovery From Opioid Use Disorder After Monthly Long-Acting Buprenorphine Treatment
MedicalResearch.com Interview with:
Dr. Walter Ling, MD
Professor of Psychiatry
Director of Integrated Substance Abuse Programs UCLA
MedicalResearch.com: What is the background for this study?
Response: RECOVER™ is a real-world, observational study looking at long-term recovery in a cohort of 533 people with moderate to severe opioid use disorder (OUD) following their transition from two Phase 3 clinical trials of SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use (CIII), into a real-world setting.1
The RECOVER study uses data from three main sources: self-administered assessments from enrolled individuals, urine drug screens (UDS) and data collected from several public sources. Recovery is examined over 24 months – the self-administered assessment and UDS results are completed by participants every three months over the course of this period. Results are being analyzed to understand the clinical, socio-economic and environmental factors associated with continuous effects of medications to treat OUD after a clinical trial.1.2
Studies such as RECOVER can help bridge the knowledge gap between the efficacy of medications as seen in the controlled clinical trial environment, and the use and effect of medications outside of a research setting and their long-term impact on patients’ health. A collaboration between Indivior and the Fralin Biomedical Institute at Virginia Tech Carilion will enable the next phase of the RECOVER study, which may provide further information to health care providers and policymakers on how to use medications to support their patients and how continuity of care can help break down barriers to evidence-based treatment.3
MedicalResearch.com: What are the main findings?
Response: In RECOVER™, observations suggest that longer treatment durations with SUBLOCADE® (buprenorphine extended-release) prior to study entry were associated with higher rates of self-reported sustained non-use of illicit opioids.1
Specifically, 75.3% of participants who were previously treated with SUBLOCADE for 12 months self-reported sustained non-use of illicit opioids for the first 12 months of the 24-month RECOVER study vs. only 24.1% of participants who were treated for 0-2 months (P = 0.001).1
Additional observations include a potential connection between treatment duration with SUBLOCADE and employment status. For example, percentages of participants employed increased from 20.3% at pre-trial screening to 46.7% at the RECOVER baseline visit and 48.3% at the RECOVER 12-month visit.1
These data should be interpreted in the context of the observation that approximately 40% of the cohort received further pharmacotherapy for OUD during the post-SUBLOCADE 12-month RECOVER period.
MedicalResearch.com: What should readers take away from your report?
Response: These findings show that long-term treatment, including counseling, may positively assist patients in focusing on their recovery, including discontinuation of illicit opioid use.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Ongoing investment in studies to understand patient progress in the short-, medium- and long-term is critical to gain additional insights about how to best use medications to support recovery efforts. Studies such as RECOVER may also provide further information to health care providers and policymakers on how active engagement in continuing outpatient care will help break down barriers to evidence-based treatment.
MedicalResearch.com: Is there anything else you would like to add?
Response: It is important for people to understand that substance use disorder (SUD) is a chronic disease, which hijacks the brain and can leave patients trapped and suffering. While existing data strongly support the short-term efficacy of medications for OUD, much less is known about overall health outcomes following long-term treatment with buprenorphine. RECOVER is the first study of its kind that follows patients out of the clinical trial setting into the real world to observe recovery over the long-term.
This study has important clinical implications for practicing clinicians. It looks back at the patients—their treatment, drug use, and other life experiences– during the year following their treatment experienced in the year prior to that.
Data from this long-term study continue to become available in 2020, providing additional insights into recovery following the post-SUBLOCADE 12-month RECOVER period. Most recently, at the 51st Annual American Society of Addiction Medicine Conference, we presented a virtual poster and audio presentation of 18-month outcomes showing that within the full cohort (N=522), 47 percent of participants self-reported sustained non-use of illicit opioids for the entire 18-month study period.4 These data should be interpreted in the context of the observation that approximately 33% of participants reported receiving further pharmacotherapy during the post-SUBLOCADE 18-month RECOVER period.
Results of the RECOVER 24-month observational study are also accepted for an oral presentation at the College on Problems of Drug Dependence Annual Meeting in June 2020, as well as at the 14th European Congress on Heroin Addiction & Related Clinical Problems (EUROPAD) in July 2020.
We hope these data, and the planned long-term follow-up study, will provide further evidence that long-term treatment along with counseling can empower patients in finding a path to regaining a purposeful and meaningful life.
Dr. Walter Ling is the study’s lead author. Dr. Ling is a paid consultant for Indivior.
- Ling, W., Nadipelli, VR, Aldridge, AP, Ronquest NA, Solem, CT, Chilcoat, H, Albright, VA, 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. Journal of Addiction Medicine. https://journals.lww.com/journaladdictionmedicine/Abstract/publishahead/Recovery_From _Opioid_Use_Disorder__OUD__After.99246.aspx
- SUBLOCADE® [Prescribing Information]. Indivior Inc., North Chesterfield, VA. October 2019.
4. Boyett, Brent, Nadipelli, VR, Solem, CT., Chilcoat, H, Ling, W. Outcomes After Discontinuation of Buprenorphine Extended-Release: 18-Months Later. https://www.eventscribe.com/2020/ASAM/PosterTitles.asp?pfp=Posters&PosterSortOrder=num&sort=ASC
Ling, W., Nadipelli, V. R., Aldridge, A. P., Ronquest, N. A., Solem, C. T., Chilcoat, H., Albright, V., Johnson, C., Learned, S. M., Mehra, V., & Heidbreder, C. (2020). Recovery from opioid use disorder (OUD) after monthly long-acting Buprenorphine treatment: 12-month longitudinal outcomes from RECOVER, an observational study. Journal of Addiction Medicine. https://doi.org/10.1097/ADM.0000000000000647
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