Combining two FDA-approved drugs may help stop some people from using methamphetamine, a new study shows.
Why it matters: Currently, there are no FDA-approved drug treatments available for people with methamphetamine use disorder – an addiction that increased during the pandemic.
Preliminary CDC data shows that deaths from methamphetamine overdose and similar stimulants increased 35% during the pandemic “as more people become anxious and depressed,” said Nora Volkow, director of the NIH’s National Drug Abuse Institute (NIDA) .
“This is very timely and urgent because we currently have no drugs that can be used to help treat people who are addicted to methamphetamines, and this is the biggest effect we have seen in terms of 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 with 403 people with moderate to severe methamphetamine dependence (using the drug on average 27 times a month), the researchers gave placebo-free groups a combination of prolonged-release naltrexone, used to treat the use of opioids and alcohol disorders; and bupropion, which is an antidepressant and aids in the cessation of nicotine.
- Published in New England Journal of Medicine Wednesday, the study found that at weeks 5 and 6, 16.5% of those who received the drug combination 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, lead 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.
- “This significantly increased the likelihood that people would stop taking meth,” Volkow told Axios. The drugs are “reducing the need to take methamphetamine, and subjectively this is described by patients as having a reduction in desire. More objectively, it is seen by the fact that our patients are not taking it.”
Bottom: Methamphetamine is highly addictive as it increases dopamine levels and takes up 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 probably several actions that this combination of drugs can take to help it be effective: its antidepressant properties and how it can block certain chemical receptors that promote addiction.
What is the next: At the moment, the FDA has approved individual drugs, which can be taken in combination as “off-label”. “I would have no hesitation in advising doctors to use it,” says Trivedi.
- But it also means that the insurance sometimes does not cover, so the researchers are meeting with the agency to determine what measures would be necessary for the official approval of the combined drug.
- “It can save lives if they use it and it is effective,” adds Trivedi.
Of importance: The study consisted mainly of white men, which is a limitation. The trial was partially funded by NIDA and Trivedi says it advises some pharmaceutical companies.
SAMHSA’s National Helpline is a free, confidential, 24-hour referral and treatment information service for individuals and families facing mental and / or substance use disorders. Call 1-800-662-HELP.