Combining two FDA-approved drugs may help stop some people’s use of methamphetamine, a new study shows.
Why it matters: Currently, there are no FDA-approved drug treatments available for people with a methamphetamine use disorder – an addiction that has increased during the pandemic.
Preliminary CDC data show that deaths from methamphetamine overdose and similar stimulants increased by 35% during the pandemic, “as more people become anxious and depressed,” says Nora Volkow, director of the NIH National Institute on Drug Abuse (NIDA).
“This is very timely and urgent because we do not currently have any medication that can be used to help treat people who are addicted to methamphetamine, and this is the biggest effect we have seen in terms of the therapeutic benefit of any intervention used to improve outcomes in patients with methamphetamine use disorder. “
What is new: In a Phase III clinical trial of 403 people with moderate to severe methamphetamine dependence (using the drug on average 27 times a month), researchers gave non-placebo groups a combination of extended-release naltrexone used to treat opioid and alcohol use. . disorders and bupropion, which is an antidepressant and cessation of nicotine.
- Published in New England Journal of Medicine On Wednesday, the study found that in weeks 5 and 6, 16.5% of those who received the combination medication responded, compared to 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 the mood swings department at UT Southwestern Medical Center.
- Participants who took the drug also tended to report fewer cravings and no significant side effects, he says.
- “This increased the likelihood that people could stop taking methamphetamine,” Volkow tells Axios. The drugs “reduce the urge to take methamphetamine, and subjectively it is described by patients who have a reduction in urge. More objectively, it is seen by the fact that our patients do not take it.”
Background: Methamphetamine is highly addictive as it raises the level of dopamine and takes over reward pathways in the brain. Methamphetamine disorders also cause structural and neurochemical changes in the brain that can lead to serious health consequences or death.
- Volkow says there are likely to be several actions that this drug combination can take that help it be effective: their antidepressant properties and how they can block certain chemical receptors that promote addiction.
What’s next: Right now, the FDA has approved the individual drugs that can be taken in combination as “off-label.” “I did not want any hestitation advising clinicians to use it,” Trivedi says.
- But it also means that insurance sometimes does not cover it, so researchers meet with the agency to decide what steps need to be taken for official approval of combination drugs.
- “It can be life-saving if they use it, and it’s effective,” Trivedi adds.
Note: The study consisted mostly of white men, which is a limitation. The lawsuit was partially funded by NIDA, and Trivedi says he is consulting with some drug companies.
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