The combination of two FDA-approved drugs could 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 increased during the pandemic.
Preliminary CDC data show that deaths from overdoses due to methamphetamine and similar stimulants increased by 35% during the pandemic “as more people become anxious and depressed,” says Nora Volkow, director of the NIH’s National Institute on Drug Abuse (NIDA).
“It is very timely and urgent because we currently have no medicine that can be used to help people who are addicted to methamphetamines, and this is the biggest effect we have seen in terms of the therapeutic benefit for any intervention used. . to improve the outcomes of patients with methamphetamine use disorder. ‘
– tells NIDA’s Nora Volkow to Axios
What’s new: In a phase III clinical trial among 403 people with moderate to severe methamphetamine addiction (using the drug on average 27 times a month), researchers gave the non-placebo groups a combination of extended-release naltrexone, which used for the treatment of opioids and alcohol use. disorders, and bupropion, which is an antidepressant and nicotine stopper.
- Published in the New England Journal of Medicine On Wednesday, the study found that 16.5% of those who received the combination drug responded at weeks 5 and 6, 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 Disorders Department at UT Southwestern Medical Center.
- Participants who used the drug also tended to report fewer cravings and have no significant side effects, he says.
- “It increases the likelihood that people can stop methamphetamine,” Volkow told Axios. The medication “reduces the urge to take methamphetamine, and is subjectively described by patients who have a reduction in craving. More objectively, it is seen by the fact that our patients do not take it.”
Background: Methamphetamine is very addictive because it increases the levels of dopamine and takes over the 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 this drug combination can take to make it effective: their antidepressant properties and how it can block certain chemical receptors that promote addiction.
What’s next: At present, the FDA has approved the individual drugs, which can be taken in combination as ‘off-label’. “I would not have a clinic that advises clinicians to use it,” Trivedi says.
- But it also means that insurance will sometimes not cover it, so the researchers are meeting with the agency to determine what steps are needed to approve official combination drugs.
- “It can be life-saving if they use it and it’s effective,” Trivedi adds.
Remarkable: The study consisted mostly of white men, which is one limitation. The trial was partially funded by NIDA and Trivedi says he is consulting for some drug companies.
SAMHSA’s National Helpline is a free, confidential, 24/7, 365 days a year treatment referral and information service for individuals and families experiencing mental and / or drug use disorders. Call 1-800-662-HELP.