Expanding buprenorphine access in the United States requires evidence-based decision-making that considers both the drug's potential dangers and its potential benefits. Risks associated with buprenorphine misuse and diversion highlight the need for careful, ongoing evaluation during each stage of increased access.

Buprenorphine is a form of opioid agonist treatment that has been demonstrated to be an effective medication for opioid addiction. It is available in different formulations and marketed under various trade names, including commonly as a buprenorphine/naloxone combination. This paper provides an overview of existing literature on the supply of buprenorphine treatment, the ability of people to access treatment with buprenorphine, and the quality of treatment received. We argue that better data for each of these aspects (...) of treatment could inform policy to expand effective treatment with buprenorphine, and we suggest steps to obtain and act on such data. (shrink)

Opioid use disorder can encompass a number of behavioral, psychological, physiological, and interpersonal symptoms which collectively impair one’s functioning to different degrees. Of all the personal and societal problems associated with OUD, the most destructive and absolute is death. Given the caustic effects of OUD on quality of life and mortality, evidence-based pharmacotherapy and psychosocial interventions are necessary. It is the collective potential for buprenorphine to increase safety and concurrent cognitive-behavioral group therapy to address substance use triggers as well (...) as comorbid psychiatric conditions, which makes this combination particularly promising for RCT of effectiveness. The purposes of this article are to identify specific ethical issues which may hinder community partners from collaborating with clinical trialist wishing to conduct CBGT buprenorphine efficacy-effectiveness trials at their agency and provide some basic guidelines and methods for addressing these community partner ethical concerns. The purpose of the manuscript is to facilitate university and substance use/mental health center community collaborations that will result in ethical clinical trial methodology and findings that meaningfully translate to efficacious, effective, and generalizable CBGT and buprenorphine hybrid interventions for OUD. (shrink)

While the prevalence of opioid use disorder among pregnant women has multiplied in the United States in the last decade, buprenorphine treatment for peripartum women with OUD has been administered to reduce risks of repeated cycles of craving and withdrawal. However, the maternal behavior and bonding in mothers with OUD may be altered as the underlying maternal behavior neurocircuit is opioid sensitive. In the regulation of rodent maternal behaviors such as licking and grooming, a series of opioid-sensitive brain regions (...) are functionally connected, including the ventral pallidum. In humans, these brain regions, interact with the supplementary motor area to regulate maternal behaviors and are functionally dysregulated by opioids. It is unclear how these brain regions respond to the emotions of their child for mothers receiving BT. In this functional magnetic resonance imaging pilot study in 22 mothers within the first postpartum year, including six mothers receiving BT and 16 non-OUD mothers as a comparison group, we devised a child face mirroring task in fMRI settings to assess maternal responses to pictures of facial expressions of own child and an unknown child in an empathic mirroring condition and a non-mirroring observation condition. In each condition, faces of neutral, ambiguous, distressed, and joyful expressions of each child were repeatedly displayed in a random order. The response of SMA during empathic mirroring vs. non-mirroring of own child was reduced among BT/OUD vs. CG. Within MBN, the left VP, critical for parental sensitivity, had a similar deficit. This study outlines potential mechanisms for investigating the risks of deficits in the neural responses to actual maternal sensitivity and parenting behavior in mothers with OUD, and potential targets for interventions that reduce stress and augment maternal behavior and child outcome. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:It's Not Always Just a RashAdam BossertI looked at the emergency department track board and saw a patient waiting for a provider who was "roomed" in a hallway stretcher with a chief complaint of a rash. I briefly considered his ultimate disposition, "He's probably fine. He can't be that sick if he was triaged as safe for the hallway." I was tired and close to the end of an (...) overnight shift and thought he would be a quick turnaround, likely discharged, since rashes are typically benign. I walked over to his stretcher after a quick chart biopsy that highlighted his mildly increased heart [End Page 24] rate on arrival as well as his history of polysubstance use and homelessness."Hey doc, I don't feel so good.""I'm sorry to hear that. What's specifically bothering you?""I am itching all over with these bumps. My skin is red, and I also think I'm withdrawing since I have body aches and chills."The interview continued.I discovered his last heroin use was approximately eight hours prior to arrival. I thought he was an ideal candidate for buprenorphine since he was actively withdrawing. I was recently licensed to prescribe this medication and excited to use my license for the first time. He declined the suggestion, however, preferring methadone instead. Buprenorphine can precipitate withdrawal if not given long enough after opioid use or if an incorrect dose is given; thus, many patients are hesitant to take it. He also stated he was predominantly here for his rash and did not want rehabilitation placement. I ordered our initiation methadone dose as well as a screening COVID-19 test and a urine drug screen test, which are both needed for rehabilitation placement in case he changed his mind.His rash was highly suspicious for scabies. He was covered with red bumps that spared only his face, some in linear distributions, and was actively scratching his arms and legs during the interview. I prefer oral ivermectin over topical permethrin for the homeless population simply for ease of administration, lower cost, and increased compliance. He received ivermectin for his scabies and knew he could return to the emergency department for a repeat dose if he was unable to fill a prescription.What happened next is, in my experience, an all-too-common scenario.The patient told me that the methadone is "doing nothing." I explained he could no longer take buprenorphine since he already received methadone, which only made him more frustrated. Unfortunately, I am restricted with the amount of methadone I can give in the emergency department, largely due to the drug's long half-life, and thus I was unable to give him more, let alone attempt titrating to his tolerance.Opioid withdrawal is not a life-threatening diagnosis; these patients are not typically admitted to the hospital. The management consists of initiating either methadone or buprenorphine, symptomatic treatment and then outpatient referral or rehabilitation placement. I explained the options to him, and he requested to be discharged since he was deferring rehabilitation. He was discharged. I was able to treat his rash but his chronic illness, opioid use disorder, was not controlled.I discharge a patient in opioid withdrawal or who has opioid use disorder almost every day, and I think most emergency medicine physicians would echo that statement. The disposition is not wrong from the perspective of the individual physician, but it feels like the system has failed these patients when I think of the frequency that they return and their baffling risk of overdose. The latter can be reduced by giving patients Narcan, the drug to reverse opioid overdose, upon discharge but this is just placing a bandage over the problem and not all emergency departments can fund this risk-reduction tool.I saw my patient's COVID-19 result return as I wrapped up my shift. It was positive. And, of course, he was in our department's hallway the whole time, only intermittently using his mask. I suddenly realized that while yes, he was withdrawing, he also may have had a symptomatic COVID-19 infection! I quickly reopened his chart, only to... (shrink)

The opioid epidemic has claimed the lives of more than 183,000 individuals since 1999 and is now the leading cause of accidental death in the United States. Meanwhile, rates of incarceration have quadrupled in recent decades, and drug use is the leading cause of incarceration. Medication-assisted treatment or MAT is the gold standard for treatment of opioid use disorder. Incarcerated individuals with opioid use disorder treated with methadone or buprenorphine have a lower risk of overdose, lower rates of hepatitis (...) C transmission, and lower rates of re-incarceration. Despite evidence of improved outcomes, many jails and prisons do not offer MAT to individuals with opioid use disorder. This seems partly due to a scientifically unjustified preference for an abstinence-only treatment approach. The absence of MAT in prisons and jails results in poor outcomes for individuals and poses a public health threat to communities. Furthermore, it disproportionately harms poor communities and communities of color. Health care providers in prisons and jails have an ethical obligation to offer MAT to individuals with opioid use disorder to mitigate risk of infectious diseases, opioid overdose and health disparities associated with incarceration. (shrink)

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices by extending (...) brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017. (shrink)

Dr. Brown, a hospitalist, admits Mark, a patient transferred from a local jail for management of cellulitis. The patient, who was taken into custody two days prior to hospital admission, has a history of intravenous heroin use. Mark explains that he had been prescribed buprenorphine-naloxone maintenance therapy for opioid use disorder for several years prior to being arrested and had not used other opioids during that time. As a policy, the jail where Mark is detained does not prescribe opioid (...) agonists, and his maintenance therapy was stopped upon his arrival there. Dr. Brown discovers that Mark is diaphoretic and appears distressed. Mark's symptoms suggest to Dr. Brown that, in addition to having cellulitis, Mark is actively withdrawing from opioids. Mark tells Dr. Brown that he has felt “horrible” since his buprenorphine-naloxone therapy was stopped and that he now has intense cravings for opioids. He asks Dr. Brown to help alleviate the withdrawal symptoms. Dr. Brown, who is accustomed to treating opioid withdrawal with opioid replacement therapy, wonders if she should initiate ORT for Mark while he is in the hospital. (shrink)