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AMethamphetamine overdose rates are skyrocketing in the United States, one of the biggest challenges for people who use stimulants and clinicians is that there is no approved treatment for this type of addiction – unlike the three drugs authorized to treat opioid use disorders.
But in a new study, researchers have found that a combination of two existing drugs – one, a treatment for opioid dependence and the other, an antidepressant – may help some people who use methamphetamine regularly to reduce their consumption. In a clinical trial, researchers reported Wednesday that 13.6% of participants treated with the two drugs had repeated urine tests without methamphetamine, compared with just 2.5% of those who received placebos.
“This is a very serious disease with fatal consequences for which there is no treatment available,” said Madhukar Trivedi, chief of the mood disorders division at the University of Texas Southwestern Medical Center and lead author of the article, which was published in the New England Journal of Medicine. “There is now hope for methamphetamine use disorder.”
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Some experts not involved in the trial were also enthusiastic.
“Methamphetamine use disorder is a very difficult disorder to treat and a truly devastating disease,” said Miriam Komaromy, medical director of the Grayken Center for Addiction at Boston Medical Center. “This study provides one of the very few medication tools that we have reason to believe is useful in treating methamphetamine use disorders, so I’m actually very excited.
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The two drugs used in the trial were injectable naltrexone and oral bupropion. The first is a treatment for opioid use disorder – it’s more commonly known by the brand name Vivitrol – and is also used for alcoholism. The latter is an antidepressant and a smoking cessation drug.
Some outside experts have said they would like to see longer-term data beyond the 12-week trial to see what lasting benefits the drugs provide. And Ayana Jordan, an addiction psychiatrist at Yale University, said she would have liked to see more information on different types of outcomes, such as whether the treatments improved people’s social connection or ability to work, even if they had not completely stopped using methamphetamine.
She also said that while it is helpful to have data indicating that this combination treatment may help some people, the results have underscored the need for better drugs that can help more patients. “It’s easier to have a more optimistic outlook because we don’t have anything working right now,” Jordan said.
Because scientists haven’t been able to develop treatments for methamphetamine addiction in particular, clinicians have looked to existing drugs to see what might provide some benefit. A 2019 clinical trial, for example, found that another antidepressant called mirtazapine helped some people reduce their methamphetamine use.
Doctors can prescribe drugs already approved by the Food and Drug Administration for other “non-compliant” purposes to try to treat methamphetamine addiction. But experts say having clinical trial data validates the approach and could also help convince payers to cover drugs.
In recent years, the country has begun to tackle its addiction crisis more, although much of the attention has focused on opioids, which have caused the highest number of fatal overdoses. But quietly, deaths from overdose of stimulants, including cocaine and methamphetamine, have increased. In the 12-month period ending in June 2020, for example, there were more than 19,600 deaths from methamphetamine, according to preliminary federal data. In 2016, there were 6,700. (Many overdose deaths involve multiple drugs.)
The new clinical trial began with more than 400 patients who regularly used methamphetamine. First, patients were randomized to receive either the drugs or a placebo. Then, those in the placebo group who did not respond initially were randomized again, either to stay on placebo or to start treatment. Taken together, 13.6% of people who received the treatments in either cycle had at least three out of four negative urine tests at the end of the trial stages, compared with 2.5% people who have received placebos.
Men made up about two-thirds of the participants. Whites made up about 71% of the participants, while 12% were black and 13.6% identified as Latino or Hispanic.
The trial had a “number to treat” of nine, meaning that nine patients would have to be given the drugs for only one to have a positive response. While that number may seem low, experts said the trial’s results were average for the effectiveness of treatments for other types of addiction, such as alcohol and tobacco. The exceptions, experts say, are methadone and buprenorphine, which have shown much higher levels of success in treating opioid use disorders.
One of the challenges of using naltrexone to treat opioid addiction is that, because of the way the drug works in the brain, people cannot have used opioids for several days before receiving the drug. ‘injection. Otherwise, naltrexone can cause debilitating withdrawal symptoms.
But because methamphetamine interacts with the brain differently from opioids, people who use methamphetamine but not opioids should be able to be treated with naltrexone without having to wait, said Trivedi, who also consults with pharmaceutical companies, including Alkermes, the manufacturer of Vivitrol.
Clinicians don’t just rely on drugs to treat addiction. Behavioral therapies like counseling are also often involved. And with stimulants in particular, a practice called contingency management, which pays people or provides other rewards for staying sober, has been shown to be effective.
Stefan Kertesz, an addiction doctor at the University of Alabama at Birmingham, who was not involved in the new clinical trial, said he could imagine offering the drug combination to patients who expressed a desire to quit to use methamphetamine, while recommending therapies such as contingency. management.
“This new trial suggests that for people with methamphetamine use disorders who are starting a very difficult healing process, a combination of drugs may improve their chances of success,” Kertesz wrote in an email. “And that’s promising.”
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