Imagine that a patient named Rosa tells him that he wakes up night after night bathed in sweat after having very realistic dreams in which he smokes fentanyl.
Dreams seem crazy. Three months ago, newly pregnant, Rosa began to be visualized as a good mother. He realized that the time had finally come to leave his self -destructive consumption of street fentanyl. With a huge effort, the treatment with buprenorphine began for its opioid consumption disorder.
As he expected, he felt a deep relief when he freed himself from the distressing symptoms of abstinence (restless legs, anxiety, bone pain, nausea and chills) and of guilt, shame and difficulties of living with addiction. But even so, Rosa was reflecting throughout the day on the rewarding euphoria of fentanil, which seemed increasingly attractive and could not escape those dreams at night.
Rosa asks you, your doctor, a higher dose of buprenorphine. Consider your request with attention. Its clinic follows the prescription guidelines of the Food and Medicines Administration (FDA), which changed very little in more than 20 years. Recommends its current recipe (16 milligrams) as a “objective” dose. Know generalized opinion among medical professionals that most patients do not need a higher dose. Many believe that patients or other people would use additional pills to get high.
But after many visits, he feels he knows Rosa well. Believe in its sincerity. She is a 25 -year -old girl with a full -time work that never lacks her appointments. Now he has a stable home after years of living on his parents’ couch. He reluctantly accepts and increases his daily dose with an additional 8 milligrams pill, totaling 24 milligrams.
On his next visit, Rosa tells him that the highest dose has taken away the desire for fentanil during the day, but that the nightmares continue. You would like to try an even larger dose.
How should I answer? The FDA guide clearly establishes that there is no evidence that supports any benefit over its new dose. You begin to doubt the sincerity of Rosa and your own judgment.
Damage of low doses in fentanyl addiction
This hypothetical scenario was repeated innumerable times in the US since 2002, when buprenorphine was approved for the first time as a treatment for opioid consumption disorder. As a family doctor specialized in addiction medicine, I have frequently treated patients who still experience withdrawal symptoms with the “target dose” and even with the maximum suggested dose of 24 milligrams.
People like Rosa, affected by an uncontrollable desire for fentanyl, either awake or in dreams, have a high risk of abandoning treatment and returning to addiction. However, between 2019 and 2020, only 2% of buprenorphine recipes were issued with doses greater than 24 milligrams.
I was able to help some of those people in my work as co -founder and medical director of a low -cost clinic, which facilitates the beginning of bunpreorphine treatment. I asked our clinical professionals to offer a higher dose when they considered that the current dose did not meet the patient’s needs.
The choice of dose can be a life or death decision. Increasing it in a more pill (up to 32 milligrams) usually makes a difference between a patient continuing or abandoning treatment. The risk of abandoning it is particularly significant for patients we usually attend in low -cost clinics, many of which face serious vital difficulties.
While patients sometimes give or sell leftover pills, investigations systematically demonstrate that illegally obtained pills are used more frequently for self -treatment, to control withdrawal and help leave opioids when there is no treatment available.
In my state, Washington, Medicaid began to cover recipes of up to 32 milligrams in 2019. However, health professionals can still find restrictions by other medical insurers and in pharmacies. Some states, such as Tennessee, Kentucky and Ohio, have consolidated dose restrictions by law.
You are interested: Dea warns that mixing fentanyl with other narcotics is increasing
The challenge of finding the appropriate dose for treatment was exacerbated for health professionals and patients with the expansion of fentanyl throughout the country since 2013. Fentanyl now dominates the unregulated supply of opioids. Fifty times more powerful than heroin, fentanyl overcomes the low dose capacity of buprenorphine to counteract its effects.
Bunpreorphine, also known by the Suboxone commercial name, which contains a mixture of buprenorphine and naloxone, is an opioid medication with the peculiarity of activating the opioid receptors of the brain and partially blocking them. It provides the right opioid effects to prevent withdrawal and desire symptoms, while blocking euphoria reward. It relieves pain like other opioids, but does not stop breathing. It can drastically reduce the risk of overdose death by up to 70%.
In medicine, there is the general concern that a dose too high can have toxic effects. However, as many doctors and researchers have observed, the use of doses too low in some treatments can also cause damage, including death if patients return to fentanyl.
After observing the good response of so many higher doses, my colleagues and I look for more information in medical literature. We discovered more than a dozen reports, dating from 1999, which evidenced that the benefits of buprenorphine constantly increase to at least 32 milligrams.
With higher doses, patients prolong treatment, consume illegal opioids less frequently, have fewer complications such as hepatitis C, have less visits to emergency and hospitalizations, and suffer less chronic pain. Brain explorations show that buprenorphine at 32 milligrams occupies more opioid receptors (more than 90 % of receptors in some brain regions) compared to lower doses. A study even showed that a sufficiently high dose of buprenorphine can directly prevent fentanyl overdose.
Patients with certain health conditions can benefit especially with higher doses. During pregnancy, as in the case of Rosa, withdrawal symptoms can be intensified due to changes in metabolism that reduce blood concentration of most medications. A higher dose may be necessary to maintain the level of effects they had before pregnancy. In addition, I discovered that my clinic patients with chronic pain, post -traumatic stress disorder or prolonged opioid consumption were more likely to find relief with a dose greater than 24 milligrams.
The American Society of Addiction Medicine recommends four treatment objectives: suppress opioid abstinence, block the effects of illegal opioids, stop opioid desire and reduce their consumption, and promote recovery -oriented activities.
Similarly, patients are looking for a comfortable and effective dose, that is, one that avoids withdrawal and desire symptoms, and allows them to avoid the consumption of illegal drugs and associated concern and stress. Many patients also yearn for feeling confident, accepted and understood by their health professional. Achieving that goal requires shared decision making.
A clinical professional can never guarantee that a patient is fulfilling all the objectives of the treatment. However, a patient who reports positive changes in his life, such as stable housing and better relationships, and who reports a low or zero desire to smoke while he is awake or dreaming, will probably be satisfied with the current dose. If a patient does not improve with an increase of dose to 32 milligrams, the clinical professional could consider a different treatment plan, such as a buprenorphine injection for 30 days, which can provide an even greater dose, or the transition to metadona, the other highly effective medication approved by the FDA for opiumoid consumption disorder.
The change in the FDA guidelines
In August 2022, a team of addiction specialists tried to make the FDA modify the dosage guidelines of the buprenorphine. They presented a request requesting a modernized guideline that would base the dosage on the patient’s response to buprenorphine, including the relief of symptoms and the reduction of illegal drug use, instead of a fixed dose “objective.” They requested the elimination of the text that incorrectly denied the evidence that patients benefit with doses greater than 24 milligrams.
The FDA heard. In December 2023, he convened a public meeting with outstanding clinical doctors, researchers and legislators specialized in addictions to review the evidence on the dosing of buprenorphine. The group reached an overwhelming consensus that there was ample investigation that demonstrated the benefit of doses greater than 24 milligrams. In addition, they doubted that the conclusions about the dosing of the guide, made before the fentanil was infiltrated in the supply of medicines, were currently applicable.
*Lucinda Grande is an associated clinical professor of family medicine from the University of Washington.
This text was originally published in The Conversation
Follow us on Google News to always keep you informed
