A new study shows that combining two FDA-approved drugs may help stop some people’s use of methamphetamine.
Why is it important: There is currently no FDA-approved drug treatment for people with methamphetamine use disorder, an addiction that was on the rise during the outbreak.
Initial CDC data showed a 35% increase in overdose deaths from methamphetamine and similar stimulants during the epidemic. “Because a lot of people are anxious and depressed,” said Nora Volkow, director of the NIH National Institute on Drug Abuse (NIDA).
“This is very immediate and urgent because we currently don’t have a drug that can be used to treat people with methamphetamine and this is the biggest impact we have seen in terms of the effects of methamphetamine). Therapeutic benefit for any intervention used to improve the outcome of patients with methamphetamine use disorder.
̵1; NIDA’s Nora Volkow told Axios.
What’s new: In a phase 3 clinical trial of 403 patients with moderate to severe methamphetamine addiction. (With an average of 27 doses per month), the researchers assigned the non-placebo group a combination of naltrexone, which is used to treat opioids and alcohol. Disorder and bupropion, which is a sedative and helps stop nicotine
- Publish as New England Journal of Medicine Wednesday, the study found that at Weeks 5 and 6, 16.5% of those who received the co-drug responded, compared to just 3.4% of those in the control group.At Week 11 and 12, the treatment group 11.4% responded. Versus 1.8% of the control group
- “The combination was almost six times better than a placebo,” said Madhukar H. Trivedi, lead author and chief of the UT Southwestern Medical Center’s department of mood disorders.
- Participants who took the drug were also more likely to report less cravings and no major side effects, he said.
- “This significantly increases the likelihood that people stop taking methamphetamine,” Volkow told Axios. “This reduced the need for methamphetamine, and it was personally described by patients as having decreased appetite. It was evident that our patients were not taking this drug.
Background: Methamphetamine is highly addictive because it increases dopamine levels and takes over the reward pathway in the brain. Methamphetamine use disorder also causes structural and neurochemical changes in the brain that can lead to serious health effects or death.
- Volkow said there could be a number of actions that could help the drug be effective: its antidepressant properties and how they might block receptors of certain chemicals that promote addiction.
What’s next: The FDA has now approved each drug, which can be used together in an “off-label” form. “I will not have a prompt to encourage doctors to use them,” Trivedi said.
- But that also means insurance is sometimes not covered, so researchers are meeting with the agency to determine what steps need to be taken to formally approve the combination drug.
- “It could save lives if they used it and it worked,” Trivedi added.
note: The study was largely composed of white men, one limitation.The ruling was partially funded by NIDA, and Trivedi said he advises certain pharmaceutical companies.
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