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The combination of two drugs approved by the FDA may help stop methamphetamine use in some people, according to a new study.
Why is this important: Currently, there is no FDA-approved drug treatment for people with methamphetamine use disorder – an addiction that has increased during the pandemic.
Preliminary CDC data shows methamphetamine and similar stimulant overdose deaths increased by 35% during the pandemic “as more people become anxious and depressed,” says Nora Volkow, director of the National Institute on Drug NIH Abuse (NIDA).
“This is very timely and urgent because we currently have no medicine that can be used to help treat people addicted to methamphetamines, and this is the greatest effect we have seen in terms of therapeutic benefit for any intervention. used. to improve outcomes in patients with methamphetamine use disorders. “
– Nora Volkow from NIDA tells Axios
What’s up: In a phase III clinical trial involving 403 people with moderate to severe methamphetamine dependence (using the drug on average 27 times per month), researchers gave non-placebo groups a prolonged-release combination of naltrexone, used to treat opioid and alcohol use and bupropion, which is an antidepressant and nicotine quit aid.
- Posted in New England Journal of Medicine On Wednesday, the study found that at weeks 5 and 6, 16.5% of people who received the combined drug responded, compared with just 3.4% of those in the control group. At weeks 11 and 12, 11.4% of the treatment group responded compared to 1.8% of the control group.
- “This combination is almost six times better than placebo,” says Madhukar H. Trivedi, senior author and head of the mood disorders division at UT Southwestern Medical Center.
- Participants who took the drug also tended to report fewer cravings and no significant adverse side effects, he says.
- “It dramatically increased the likelihood that people could stop using methamphetamine,” Volkow tells Axios. The drugs “reduce the urge to take methamphetamine, and subjectively this is described by patients as having a reduced craving. More objectively, it shows in our patients not taking it.”
Context: Methamphetamine is highly addictive because it increases dopamine levels and supports reward pathways in the brain. Methamphetamine use disorder also causes structural and neurochemical changes in the brain that can lead to serious health consequences or death.
- Volkow says there are probably several actions this drug combination can take to help it be effective: their antidepressant properties and how they can block certain chemical receptors that promote addiction.
And after: Currently, the FDA has approved individual drugs, which can be taken in combination “off-label”. “I would have no hesitation in advising clinicians to use it,” Trivedi says.
- But it also means that sometimes insurance won’t cover it, so researchers are meeting with the agency to work out what steps to take for formal approval of combination drugs.
- “It could save lives if they used it and if it was effective,” Trivedi adds.
To note: The study focused on white males, which is a limitation. The trial was partially funded by NIDA and Trivedi says he’s consulting with some drug companies.
The SAMHSA National Helpline is a free, confidential referral and information service, available 24/7, 365 days a year, for individuals and families facing mental and / or related disorders. substance use. Call 1-800-662-HELP.
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