NIDA's Clinical Trial's Initiative (CTN) video provides an overview of Buprenorphine, a semi-synthetic opioid, used in the treatment of adults with opioid use disorder. The video highlights the opioid epidemic in the USA, the potential benefits and risks of the prescription of opioids for pain management including the risk of the development of opioid use disorder.
Video length: 8:30
Narrator speaking: While the opioid overdose epidemic originated in the late 1990’s from an increase in the misuse of prescription opioids, it is currently largely driven by heroin and synthetic opioids. In 2016, opioids were involved in over 42,000 deaths which was five times higher than reports indicated in the late 1990’s.
Like many providers across the nation, you may be seeing an increasing number of patients with opioid use disorder. And you’re likely asking yourself, “What can I do to help?”
These drugs interact with opioid receptors on nerve cells in the body and brain. When taken for a short period of time under the supervision of a health care provider, these pain relievers are generally safe. However, because they are capable of producing feelings of euphoria, they can also be misused.
Illicit use, and even regular use as prescribed by a healthcare provider, may lead to
- opioid use disorder,
- or overdose.
According to the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, opioid use disorder is a problematic pattern of opioid use that leads to clinically significant impairment or distress. It requires patients to meet at least 2 of 11 established criteria within a 12-month period. It’s important to understand that OUD is a chronic and relapsing condition and should be treated accordingly.
Patients with OUD need ongoing care. The use of medication, combined with psychosocial treatments, is the most effective treatment modality. While there are three approved and effective medications to treat OUD, this tutorial will focus on sublingual buprenorphine in the treatment of adults with opioid use disorder. Sublingual buprenorphine was approved in 2002 by the U.S. Food and Drug Administration for use by qualified prescribers in their respective medical settings.
Buprenorphine is a semi-synthetic opioid. It is long acting, with an elimination half-life of 37 hours allowing for once daily dosing for most patients.
Buprenorphine acts as a partial agonist at the mu-opioid receptor. It has a high affinity for this receptor and is slow to dissociate from it. But because buprenorphine is a partial agonist, there is a ceiling for its opioid effects, such as respiratory depression, making it safer than full opioid agonists.
Buprenorphine helps control cravings and has the protective effect of blocking other opioids that the patient might take.
Currently, buprenorphine is available in several formulations.
Sublingual or Buccal combinations of buprenorphine and naloxone are the most commonly available preparations. They are available in film or tablet form. The addition of naloxone in the combination formulation helps to reduce the potential for misuse and diversion and should be the default formulation for most patients.
Monotherapy buprenorphine, available in tablet form, has a higher misuse liability. This medication is often reserved for pregnant patients and those with documented allergies to naloxone.
Subdermal buprenorphine, an implant formulation, delivers a steady low dose over a 6-month period and reduces the risk of misuse and diversion. Extended-release buprenorphine is a subcutaneous injectable formulation that delivers buprenorphine at a controlled rate over a one-month period. Both, the implantable and injectable formulations, remove the need for patients to remember to take daily medication and provide an opportunity to focus on other aspects of treatment related to psychosocial support.
Once a patient has an OUD diagnosis and is selected for buprenorphine therapy, you need to discuss some key information:
It’s important to mention the possible side effects of buprenorphine. It is safe to use for most patients, with commonly reported side effects such as
- or headache may occur.
Rare side effects include allergic reactions, opioid withdrawal symptoms (such as insomnia, irritability, etc.) and liver damage. Providers should ask patients about all active medications they are taking, to avoid potentially risky side effects.
Patients also need to know that they should avoid mixing benzodiazepines with buprenorphine due to extremely dangerous interaction effects.
How do I start a patient on buprenorphine?
First, it is critical to ensure that the patient has attained a sufficient level of withdrawal before the induction of buprenorphine.
The more time that has passed between their last substance use and their first dose of buprenorphine, the easier induction will be. Patient withdrawal can be assessed using the Clinical Opiate Withdrawal Scale (COWS), and induction should occur with a COWS score of a 6 or higher.
The induction dose of buprenorphine may begin with 2 -4 mg and usually stabilizes at 12 – 16 mg per day.
During the next phase, which focuses on the maintenance of abstinence from opioids and long-term withdrawal management, patients will need weekly visits to assess how buprenorphine is working for the patient, identify any problems, and adjust the dose if necessary.
- With correct dosing and treatment adherence, patients will likely report reduced cravings and decreased illicit opioid use, as shown by negative urine tests.
- During visits, staff should ensure that the patient is getting the appropriate psychosocial supports for recovery.
- For patients with comorbid conditions—such as chronic pain, other substance use disorders, and psychiatric conditions—you may need to provide a referral to specialty care.
- If patient injects opioids, review the associated risk of HIV/Hepatitis C and the need for testing.
- It’s also important to monitor the liver health of patients on buprenorphine. Although liver problems have been reported, they are infrequent.
- Providers should discuss treatment duration with patients, emphasizing that there is no clearly defined length of time for buprenorphine treatment and the longer this medication is taken, the less likely the patient is to return to opioid use.
- Patients should also know that relapse rates are high when this medication is stopped. Relapse occurs even when medication is tapered and patients are highly motivated to stop opioid use.
- It’s absolutely critical for patients to understand that they risk overdose and death by using opioids after they discontinue these treatment medications. Explain that when the patient is not taking full mu-opioid receptor agonists, such as heroin or oxycodone, his or her tolerance is reduced, and relapse is more likely to result in an overdose. Naloxone can be co-prescribed to prevent overdose deaths.
Now that you know why buprenorphine is
- its available formulations,
- and how it is prescribed and monitored to treat OUD and prevent overdose deaths,
let’s look at how providers can obtain a waiver and meet the licensing requirements. To be able to prescribe buprenorphine, providers must complete a specified number of hours of training, which may vary by type of provider, and have capacity to provide or refer to counseling or ancillary services as needed.
The procedure for getting a waiver and the specific requirements have been evolving. In order to begin prescribing, physicians are required to complete 8 hours of training, apply for a waiver, and receive a special identification number from the DEA. Recent legislation has also allowed nurse practitioners and physician assistants to apply for buprenorphine waivers as well. NPs and PAs are required to take additional training before applying. The Substance Abuse and Mental Health Services Administration (SAMHSA), has up-to-date information for providers who want to be able to prescribe buprenorphine and other medications to treat OUD.
This video was produced through the National Institute on Drug Abuse.
For additional NIDA products and other select partner resources related to buprenorphine, visit the following resources online.