Dr. Mark Gold’s Research You Can Use
Recently released and revised medication-assisted treatments (MAT) have been an important area of research to counter the present opioid epidemic. MATs have helped patients in their recovery. It is the administration of opioid agonists (methadone, buprenorphine, oxycodone), antagonists (naltrexone, naloxone), and combinations of the two (buprenorphine/naloxone). While shown to be successful, particularly when combined with psychological counseling, rehabilitation, and ongoing treatment, it comes with its own constraints and challenges.
Buprenorphine has been established as an effective treatment for opioid use disorder (OUD). Being a high-affinity, partial agonist for the mu-opioid receptor buprenorphine inhibits withdrawal symptoms and cravings, decreases illicit opioid use and blocks exogenous opioid effects including respiratory depression. Other pharmacologic benefits of buprenorphine lie in its superior safety profile as compared to those of full opioid agonists and its long half-life that allows for daily or less-than-daily dosage.
The evolution of buprenorphine therapy for OUD
Buprenorphine was first developed by Reckitt Benckiser in the 1960s and has been used to treat moderate pain for years. It has been used internationally for the treatment of OUDs since the 1990s and has been available in the United States for more than a decade. Initial practice recommendations were intentionally conservative, based on expert opinion and primarily influenced by methadone regulations.
Approved for clinical use in 2002 by the Food and Drug Administration (FDA), buprenorphine, co-formulated with naloxone, became the first and only medication to treat opioid dependency that could be prescribed or dispensed in physician offices.
This made OUD treatment substantially more accessible than methadone. However, this development was accompanied by strict limitations regarding patients per physician prescriber, detailed guidelines imposed by insurers and government agencies, and cautious recommendations adopted by policymakers.
A decade later, continued research has helped establish a better understanding of buprenorphine treatment in practice. Updated knowledge acknowledges the need for more individualized care.
Paradoxical effect of strict regulations on patients
A recent article published by a research team at the University of Massachusetts at Annals.org addresses the paradox created by common, widespread and outdated practices that continue to potentially harm patients instead of helping them.
Location of buprenorphine induction. The previous approach, as per the Treatment Improvement Protocol (TIP) 40 for buprenorphine released by SAMHSA in 2004, has relied heavily on the medical setting being the ideal setting for safe and effective buprenorphine induction. New findings and recommendations, however, have found home induction to be safe and effective. Initiated as early as 2003, home induction programs are supported by considerable evidential data that found no negative consequences of home induction in support of patient education and telephone support. Office induction can actually create barriers for treatment and scheduling.
Combination of buprenorphine with a benzodiazepine. Benzodiazepines and buprenorphine have been believed to be a toxic combination. Recent research has contrarily established that withholding buprenorphine due to benzodiazepine use can potentially result in adverse effects from untreated opioid addiction. For patients who have taken appropriately prescribed benzodiazepines for a year with no misuse, tapering benzodiazepines may be “contraindicated and unrealistic” as observed by TIP 63. Co-prescribing of buprenorphine and benzodiazepines remains prevalent, and overdose deaths involving buprenorphine are rare.
Relapse during buprenorphine treatment. Patients undergoing relapse have been considered failures at buprenorphine treatment. However, recent data supports that relapsing patients only require additional support and resources rather than taking them out of buprenorphine treatment. According to estimates by the World Health Organization, adherence to long-term therapy for chronic illness is no more than 50 percent. These rates are even lower for populations affected by poverty or shortage of social resources.
Counseling requirements. Traditional counseling has been misunderstood to be essential to benefit from buprenorphine treatment. New recommendations have deemed it not necessary, however. Every patient is different and requires different forms of behavioral health support. Mandating a particular type of behavioral support for all patients is shortsighted and unrealistic, the authors noted.
Criteria of drug testing. Drug testing had previously been labeled as a measure to point out ‘unsuccessful’ patients. Current recommendations propose drug testing as a tool for supporting recovery instead. TIP 63 advises clinicians to explain to patients that testing will help them achieve treatment goals.
Use of other substances during buprenorphine treatment. Previous approaches were based upon the understanding that patients with polysubstance abuse were not appropriate candidates for buprenorphine treatment. Updated data proposes that buprenorphine exerts no direct effect on other substance use such as alcohol and marijuana.
Duration of buprenorphine treatment. Contrary to previous approaches, new findings and recommendations advise that patients should receive buprenorphine as long as it is beneficial for them. A review of buprenorphine therapy discontinuation found that “rates of relapse to illicit opioid use exceeded 50% in every study.” The decision to discontinue any medical treatment needs to be a shared process between the patient and clinician.
Buprenorphine treatment for adolescents
The past decade has seen the emergence of a significant population of adolescents and young adults with OUD. Despite the availability of a wide array of medications and psychosocial treatments, accessibility and retention in treatment continue to be limited for this young population. More effective, practical and scalable treatment models are required to accommodate the unique needs of young adolescents.
A recent narrative review assessed three randomized controlled trials and multiple observational studies evaluating the use and efficacy of buprenorphine to treat this population. Based on these studies, the authors of this review by Borodovsky et al. encouraged establishing OUD among youth as a chronic medical condition requiring a long-term management strategy.
Buprenorphine treatment indicates efficacy in terms of program retention, prevention of overdose and reduction in drug use. Yet patient adherence remains to be the top concern, as 5-year outcomes, comparison to methadone and conjunction treatment options need to be re-evaluated.
As a result, long-acting buprenorphine implants are being developed as a potentially superior method of agonist delivery. The latest implant has been approved by the U.S. Food and Drug Administration in Probuphine which can deliver steady-state levels of buprenorphine over the course of 6 months. This implant does come with its own set of limitations and side effects that need to be researched further.
In theory, implantable and injectable buprenorphine medication can substantially enhance adherence and inhibit diversion or misuse similar to longer-acting injectable naltrexone. Yet, the empirical data remains unavailable to confirm these potentially significant patients and public health benefits.
Future research must include exploring the long-term effects of Probuphine, the consequences of widening the demographic to patients and the development of alternative options for treatment. Comparisons also need to be drawn between Probuphine and other medications such as Bunavail and Suboxone (all buprenorphine/naloxone combination drugs) or naltrexone.
In the most recent update, FDA moved forward with finalizing a new policy to enhance innovation and development of new buprenorphine treatments for OUD on a broader scale.
Final guidance by the FDA, “Opioid Use Disorder: Developing Buprenorphine Depot Products for Treatment,” outlined the agency’s present outlook on drug development and trial design issues associated with the study of buprenorphine depot products, including injections and implants.
The aim is to introduce new treatment paradigms that may be less subject to misuse, abuse, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films.
In the U.S. alone, more than 2.4 million people suffer from OUD. Amid such dire circumstances, patient safety is highly dependent upon longitudinal care that is evidence-based, accessible and prioritizes harm reduction.
Focusing on individualized, all-encompassing care that incorporates patient-centered outcomes, can better help patients with OUD to achieve remission and lead improved lives.
About the Author:
Mark S. Gold, M.D. served as Professor, the Donald Dizney Eminent Scholar, Distinguished Professor and Chair of Psychiatry from 1990-2014. Dr. Gold was the first Faculty from the College of Medicine to be selected as a University-wide Distinguished Alumni Professor and served as the 17th University of Florida’s Distinguished Alumni Professor.
Learn more about Mark S. Gold, MD
About the Transcript Editor:
A journalist and social media savvy content writer with extensive research, print and on-air interview skills, Sana Ahmed has previously worked as staff writer for a renowned rehabilitation institute, a content writer for a marketing agency, an editor for a business magazine and been an on-air news broadcaster.
Sana graduated with a Bachelors in Economics and Management from London School of Economics and began a career of research and writing right after. Her recent work has largely been focused upon mental health and addiction recovery.
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Published on April 1, 2019
Reviewed by Jacquelyn Ekern, MS, LPC on April 1, 2019
Published on AddictionHope.com