Defining low-threshold buprenorphine treatment (original) (raw)

. Author manuscript; available in PMC: 2021 Mar 1.

Abstract

Buprenorphine treatment for opioid use disorder is safe and effective, but only a fraction of Americans who need treatment receive it. One reason for this is that many buprenorphine treatment programs have rigid requirements for entry and continuation, limiting the number of people who receive treatment. “Low-threshold treatment” is a term used to describe an alternative approach that attempts to remove as many barriers to treatment as possible. However, few studies have described its essential features. In this article, we define low-threshold treatment and propose the approach be guided by the following principles: 1) Same-day treatment entry 2) Harm reduction approach 3) Flexibility, and 4) Wide availability in places where people with opioid use disorder go. We discuss the evidence and rationale for these principles and directions for future research.

Keywords: buprenorphine, low-threshold, opioid use disorder, harm reduction

Opioid use disorder treatment with long-acting opioid medications prevents opioid-related harms by reducing opioid craving, maintaining opioid tolerance, and blocking the effects of illicit opioids. People with opioid use disorder need consistent access to these medications, and overdose mortality is far lower during periods of treatment than after medications are stopped (Sordo et al., 2017). However, as opioid overdose rates rise annually in the United States, few people with opioid use disorder (OUD) receive medications (Saloner et al., 2015), and those who do are in treatment for only brief periods of time (Bart, 2012).

Buprenorphine maintenance treatment is safe and effective, but continues to be underutilized in part because of artificial barriers created by the United States healthcare system. Providers must complete an eight-hour certification training, which limits potential prescribers. More importantly, though, programs can create high thresholds for entry and continuation of treatment, which limits the number of potential patients to those who meet strict criteria for program entry and are able to comply with rigid rules and regulations. Alternatively, advocates have called for low-threshold buprenorphine treatment models in order to maintain consistent medication access; however, few studies have defined essential features of “low-threshold” care. Defining these essential features can provide a framework for future research and clinical programming.

Experience with low-threshold methadone maintenance treatment illustrates features likely to be important for low-threshold buprenorphine treatment. In the United States, same day treatment entry has improved methadone maintenance treatment uptake (Dennis et al., 1994). Internationally, where treatment is less regulated than in the United States, methadone has been offered in multiple settings, which improves accessibility. The Netherlands offers a spectrum of care with high, medium, and low-threshold clinics (Langendam et al., 2018). Low-threshold clinics operate in mobile settings likely to reach individuals who do not regularly access medical care. These clinics have no waiting lists, no requirement for abstinence, and few barriers to treatment entry or reentry. The Netherlands’ low-threshold approach was associated with reductions in mortality (Langendam et al., 2018), HIV and Hepatitis C incidence (Van Den Berg et al., 2007), and criminal activity (Ryrie et al., 1997)., In Canada, methadone was deregulated in 1996 allowing for prescribing in office-based settings, including syringe exchange programs. Canada’s low-threshold approach was associated with reductions in HIV risk behaviors (Millson et al., 2018), HIV incidence (Ahamad, et al., 2015), and mortality (Nolan et al., 2015).

Building from preliminary work (Bhatraju et al., 2017) and using methadone’s example, we broadly define low-threshold treatment as an approach that provides consistent medication access – treatment should be easy for patients to start and continue. We believe that low-threshold buprenorphine treatment should be guided by the following principles: 1) Same-day treatment entry 2) Harm reduction approach 3) Flexibility, and 4) Wide availability in places where people with opioid use disorder go.

Same-day treatment entry

With the high risk of overdose from synthetic opioids, people with OUD who are interested in and meet criteria for buprenorphine treatment should be able to see a provider right away and start medication on day one. Waiting lists, prior authorizations, and cumbersome programmatic requirements can create deadly delays. Typically, several office visits have been required for assessment and treatment initiation (i.e. treatment induction). However, treatment induction at home is safe and feasible (Lee et al., 2014). Therefore, providers can assess patients and prescribe buprenorphine during the first visit. A same-day approach would likely increase the proportion of people interested in treatment who actually start and continue it.

Harm reduction approach

The most immediate goals of buprenorphine treatment are improving quality of life and protecting against opioid overdose, both of which can be achieved by reducing illicit opioid use. Other benefits from reduced substance use and engagement in medical care include reductions in HIV (MacArthur et al., 2012) and Hepatitis C Virus transmission (Minozzi et al., 2017). When patients continue to use illicit opioids or other substances, some buprenorphine treatment programs stop prescribing, but treatment cessation can carry great risk. Abruptly stopping buprenorphine leads to opioid withdrawal and reduced tolerance, leaving patients vulnerable to overdose with subsequent illicit opioid use. Treatment cessation on account of non-opioid substance use, such as cocaine, does not make clinical sense, as buprenorphine treatment should only be expected to treat opioid use disorder (Martin et al., 2018).

During the course of treatment, buprenorphine providers may decide to refer patients who are not reaching their treatment goals to a higher level of care, if it is available (e.g., methadone maintenance treatment). However, there is no data on the completion rates of referrals from buprenorphine to higher intensity programs, and there is the risk that patients will drop-out of care and resume their pre-treatment opioid use with all its associated risks. Thus, for many patients, the risks of involuntary treatment cessation may exceed the benefits.

For some patients, achieving abstinence takes time, and other patients may not have complete abstinence as a goal. Prescribers should adopt a non-judgmental attitude and acknowledge that different patients have different priorities and goals for treatment. A non-judgmental attitude can improve the provider-patient relationship and reduce stigma, a barrier to engaging in treatment (Krawczyk et al., 2018). With a harm reduction approach, patients and providers can have frank conversations about the patients’ goals for treatment and work together to achieve them.

Flexibility

The strict regulations around methadone maintenance can create a system where treatment becomes the option of last resort because of the sacrifices that patients need to make to remain in treatment. Treatment programs should be flexible enough for patients to fulfill work, family, and other obligations. Non-evidence-based program requirements, such as picking medication up daily, mandatory intensive psychosocial counseling, or attendance at mutual aid groups (e.g., Narcotics Anonymous), may deter patients from starting or continuing buprenorphine treatment (Martin et al., 2018). Every effort should be made to offer the formulation of buprenorphine the patient prefers, whether that is sublingual films, tablets, or long-acting injectable medications. Monthly appointments are sufficient for many patients, and weekly or biweekly visits can be reserved for patients who are not meeting their treatment goals and who are willing and able to come more frequently. Based on multiple clinical trials, routine counseling during regularly scheduled office visits is likely sufficient for most patients to achieve good treatment outcomes, so requiring additional counseling should not be required (Carroll et al., 2017). Mutual aid groups may offer recovery supports, and additional psychosocial counseling could be tailored to individual patient needs and wishes (e.g., cognitive behavioral therapy for comorbid depression), so that patients have both the support and flexibility they need to meet their goals.

Available in non-traditional settings

Low-threshold buprenorphine treatment should be available in primary care and other office-based settings, but it also must reach people with OUD who are reluctant to engage in medical care. Patients may have bad experiences with medical care in the past, fear they will be mistreated, or simply find it too difficult to get to an unfamiliar place. Treating patients in non-traditional settings can be a solution. Offering treatment in emergency departments and at syringe exchange programs has been shown to be feasible (Stancliff et al., 2012), and homeless health care sites offering buprenorphine have demonstrated excellent treatment outcomes (Alford et al., 2007). Mobile treatment sites have been shown to engage high risk, previously out of care individuals (Halle et al., 2014). Providing low-threshold buprenorphine treatment in non-traditional settings that are accessible to patients may help them start and continue treatment.

Considerations about low-threshold treatment

Low-threshold buprenorphine treatment may look different than well-studied models of medical management in primary care or specialty settings. Low-threshold models may offer drop-in hours, peer support, and non-medical services (e.g., coffee and snacks) that encourage engagement. Studies should determine best practices. However, the principles outlined above could be applied to most buprenorphine practices.

We also believe that low-threshold treatment does not mean “no threshold” treatment. A low-threshold approach requires appropriate application of OUD diagnostic criteria and full assessment of medical and psychiatric co-morbidities. Providers should address concerns about buprenorphine diversion if they arise. If a patient is not taking their medication, the benefits of buprenorphine maintenance will be lost, and stopping the prescription is likely warranted.

Low-threshold treatment will not work for everyone. Low-threshold treatment principles emphasize medication access, engagement, and treatment retention, while higher levels of care should offer additional structures and higher intensity services to those who need them. If a patient is not meeting their own goals, their provider could refer them for additional psychosocial counseling, mutual aid groups, or even to a higher intensity program, depending on the needs of the patient (Table 1). With a low-threshold approach, the provider and the patient should strive to find a treatment plan that is mutually acceptable. When a provider recommends a higher level of care but the patient is not in agreement, the provider must make a judgement about whether the benefits outweigh the risks of continuing treatment. No treatment plan will work for all patients, highlighting the need for a patient-centered approach.

Finally, low-threshold buprenorphine treatment is a relatively new concept. Studies could quantify its risks and benefits; however, with buprenorphine’s strong safety profile and limited evidence supporting many of the high threshold program requirements, there is a compelling reason to prioritize medication access. The tremendous gap between the number of Americans who need and receive OUD treatment must be closed.

Conclusion

With a low-threshold approach, healthcare providers can help patients start and continue buprenorphine treatment by offering same-day treatment, a harm reduction approach, flexible program requirements, and offering treatment in settings where there is the highest need, which may not be within the walls of a traditional clinic. Low-threshold buprenorphine treatment cannot address all challenges of the opioid overdose crisis, but it is one important strategy to protect the health of people with opioid use disorder.

Acknowledgements

The work was supported by NIH/National Center for Advancing Translational Science (NCATS) Einstein-Montefiore CTSA Grant Number UL1TR001073

Funding sources: Dr. Fox is supported by R01 DA044878

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