The combination of two FDA-approved drugs may help stop methamphetamine use by some people, according to a new study.
Why it’s important: There are currently no FDA-approved drug treatments available for people with methamphetamine use disorder, an addiction that has increased during the pandemic.
Preliminary data from the CDC shows that deaths from methamphetamine overdose and similar stimulants increased 35% during the pandemic “as more people become anxious and depressed,” says Nora Volkow, director of the National Institute on Abuse. of Drugs (NIDA) of the NIH.
“This is very timely and urgent because we currently do not have drugs that can be used to help treat people addicted to methamphetamines, and this is the biggest effect we have seen in terms of therapeutic benefit for any intervention used by improve outcomes in patients with methamphetamine use disorder “.
– NIDA’s Nora Volkow tells Axios
What’s new: In a phase III clinical trial of 403 people with moderate to severe methamphetamine addiction (using the drug an average of 27 times a month), the researchers gave the non-placebo groups a combination of prolonged-release naltrexone. which is used to treat the use of alcohol and opioids. disorders, and bupropion, which is an antidepressant and helps stop nicotine.
- Published in New England Journal of Medicine On Wednesday, the study found that at weeks 5 and 6, 16.5% of those receiving the combination drug responded, compared with only 3.4% of those in the control group. At weeks 11 and 12, 11.4% of the treatment group responded, compared with 1.8% of the control group.
- “This combination is almost six times better than placebo,” says Madhukar H. Trivedi, lead author and head of UT Southwestern Medical Center’s mood disorder division.
- Participants who took the drug also tended to report fewer cravings and no significant adverse side effects, he says.
- “This significantly increased the likelihood that people could stop taking methamphetamine,” Volkow tells Axios. Medications “reduce the urge to take methamphetamine and, subjectively, this is described by patients with a reduced desire. More objectively, it is seen by the fact that our patients do not take it.”
Background: Methamphetamine is highly addictive as it increases dopamine levels and takes over the reward pathways in the brain. Methamphetamine use disorder also causes structural and neurochemical changes in the brain that can lead to serious health or death consequences.
- Volkow says there are likely to be several actions that this combination of medications can help you make to be effective: their antidepressant properties and how they can block certain chemical receptors that promote addiction.
What follows: Right now, the FDA has approved individual medications, which can be taken in combination as “off-label”. “I wouldn’t have any hesitation advising doctors to use it,” Trivedi says.
- But that also means insurance will sometimes not cover it, so investigators are meeting with the agency to determine what steps should be taken for the official approval of combination drugs.
- “It could save lives if they use it and it’s effective,” Trivedi adds.
Note: The study consisted primarily of white men, which is a limitation. The trial was funded in part by NIDA and Trivedi says it consults for some pharmaceutical companies.
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