The combination of two FDA-approved drugs may help stop methamphetamine use by some people, a new study shows.
Why does it matter: There are currently no FDA-approved drug treatments available for people with a methamphetamine disorder – an addiction that has increased during the pandemic.
Preliminary data from the CDC show that overdose deaths caused by methamphetamine 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 medicines that can be used to help treat people with methamphetamine addictions and this is the biggest effect we have seen in terms of the therapeutic benefit for any intervention used to improve outcomes in patients with methamphetamine use disorder. “
– Nora Volkow from NIDA tells Axios
What’s new: In a phase III clinical trial of 403 people with moderate to severe methamphetamine dependence (using the drug an average of 27 times a month), the researchers offered non-placebo groups a combination of long-release naltrexone, used for treatment of opioid and alcohol use. disorders and bupropion, which is an antidepressant and a nicotine cessation aid.
- 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 the mood disorder division at UT Southwestern Medical Center.
- Participants who took the drug also tended to report fewer cravings and no significant side effects, he says.
- “This has significantly increased the likelihood that people will be able to stop taking methamphetamine,” Volkow told Axios. Medications reduce “the need to take methamphetamine and, subjectively, it is described by patients with reduced appetite. More objectively, it is seen by the fact that our patients do not take it “.
Background: Methamphetamine is very addictive because it increases dopamine levels and takes over the reward pathways in the brain. Disruption of methamphetamine use also causes structural and neurochemical changes in the brain that can lead to serious health or death consequences.
- Volkow says there are probably several actions this combination of drugs can take that help it be effective: their antidepressant properties and how they can block certain chemical receptors that promote addiction.
What’s next: At this time, the FDA has approved individual drugs, which can be taken in combination as “off-label”. “I would have no hesitation in advising clinicians to use it,” says Trivedi.
- But, this also means that insurance will not cover it sometimes, so researchers are meeting with the agency to determine what steps should be taken for the formal combined approval of medicines.
- “It could be a lifesaver if I use it and it’s effective,” adds Trivedi.
Note: The study consisted of most white men, which is a limitation. The process was partially funded by NIDA and Trivedi says it is consulting for some drug companies.
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