Combining two FDA-approved drugs may help stop some people’s use of methamphetamine, a new study shows.
Why it matters: Currently, no FDA-approved drug treatments are available for people with methamphetamine use disorder – an addiction that has increased during the pandemic.
Preliminary CDC data shows that the number of overdose deaths from methamphetamine and similar stimulants increased by 35% during the pandemic “as more people become anxious and depressed,” said Nora Volkow, director of the National Institute on Drug Abuse (NIDA) of the NIH.
“This is very timely and urgent as we currently do not have any drugs that can be used to help treat people addicted to methamphetamine, and this is the greatest effect we have seen in terms of the therapeutic benefit of each used. intervention. to improve outcomes in patients with methamphetamine use disorder. “
– NIDA’s Nora Volkow tells Axios
What’s new: In a phase III clinical study involving 403 people with moderate to severe methamphetamine addiction (who took the drug an average of 27 times per month), researchers gave the non-placebo groups a combination of extended-release naltrexone, which is used to treat opioid and alcohol use disorders, and bupropion, which is an antidepressant and an aid in nicotine withdrawal.
- Published in the New England Journal of Medicine On Wednesday, the study found that at weeks 5 and 6, 16.5% of those who received the combination drug 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 to 1.8% of the control group.
- “This combination is nearly six times better than placebo,” said Madhukar H. Trivedi, lead author and chief of the mood disorders division at UT Southwestern Medical Center.
- Participants who took the drug also tended to report less cravings and no significant adverse side effects, he says.
- “This significantly increased the chance that people could stop taking methamphetamine,” Volkow tells Axios. The drugs “reduce the urge to take methamphetamine, and subjectively this is described by patients as a reduction in cravings. More objectively, it is seen by our patients not taking it.”
Background: Methamphetamine is highly addictive, as it increases the amount 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 consequences or death.
- Volkow says there are likely several actions this drug combination can take to make it effective: their antidepressant properties and how they can block certain chemical receptors that promote addiction.
What’s next: Currently, the FDA has approved individual drugs, which can be taken in combination, as “off-label.” “I wouldn’t hesitate to advise doctors to use it,” says Trivedi.
- But that also means that sometimes the insurance doesn’t cover it, so the researchers are consulting with the agency to determine what steps should be taken for the official approval of combination drugs.
- “It can be a life saver if they use it and it is effective,” adds Trivedi.
Of interest: The study mainly consisted of white men, which is a limitation. The trial was funded in part by NIDA, and Trivedi says he is consulting for a number of pharmaceutical companies.
The SAMHSA National Helpline is a free, confidential, 24/7, 365 days a year referral and information service for individuals and families with mental disorders and / or substance use. Call 1-800-662-HELP.