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Press release
Wednesday January 13, 2021
A combination of two drugs, injectable naltrexone and oral bupropion, has been shown to be safe and effective in treating adults with moderate or severe methamphetamine use disorder in a phase III clinical trial double blind, placebo controlled. The results suggest that this combination therapy may be a promising addition to current treatment approaches, such as cognitive behavioral therapy and contingency management interventions, for a very serious disease that remains difficult to treat and overcome. The research, published today in The New England Journal of Medicine, was conducted at multiple sites within the National Institute on Drug Abuse Clinical Trials Network (NIDA CTN). NIDA is part of the National Institutes of Health.
“The opioid crisis and the resulting overdose deaths in the United States are now well known, but what is less recognized is that there is a growing crisis of overdose deaths involving methamphetamine and other stimulants. However, unlike opioids, there are currently no drugs approved for the treatment of methamphetamine use disorders, “said Nora D. Volkow, MD, director of NIDA.” This breakthrough demonstrates that medical treatment problems with methamphetamine use may help improve patient outcomes.
The study titled “ Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder study ”, or ADAPT-2, was conducted from 2017 to 2019 in clinics of several community-based treatment programs nationwide and recruited 403 adult volunteers aged 18 to 65 years with moderate to severe disorders. methamphetamine use disorder. All participants wanted to reduce or stop using the drug and were randomly assigned to the treatment or control group.
At each of the two six-week stages, volunteers in the treatment group were injected with sustained-release naltrexone, a drug used to treat opioid and alcohol use disorders, every three weeks and were given taken daily prolonged-release tablets of bupropion, an antidepressant. also used as a treatment to help stop nicotine Those in the control group received paired injectable and oral placebos during the same time periods. Investigators performed four urine drug screens at the end of each step of the trial. Participants were considered to have responded to treatment if at least three of the four urine screens were negative.
Overall, participants responded at a significantly higher rate in the treatment group. When screened in weeks five and six, 16.5% of people who received the naltrexone / bupropion combination responded, compared to only 3.4% of those in the control group. Likewise, upon screening at weeks 11 and 12, 11.4% of the treatment group responded, compared to 1.8% of the control group. The researchers calculated that the number to be treated (NNT) was 9. The NST is a way of describing the usefulness of a medical intervention that indicates the number of people who would need to receive treatment in order for it to benefit a patient. nobody. Investigators reported that with an NST of 9, the benefit of naltrexone / bupropion as a treatment for methamphetamine use disorder is similar to most medical treatments for mental health disorders, including antidepressants. prescribed for depression or naltrexone prescribed for alcohol use disorder.
Participants in the treatment group were rated as having fewer food cravings than those in the placebo group and reported greater improvements in their lives, as measured by a questionnaire called Treatment Effectiveness Rating. Importantly, no significant adverse effects were associated with dual drug therapy. Treatment adherence was encouraged by adherence counseling and mobile app reminders and has remained high at 77.4% and 82.0% in the treatment and placebo groups, respectively, over the past six years. weeks of the study.
“Long-term methamphetamine misuse has been shown to cause diffuse changes in the brain, which may contribute to serious health consequences beyond the addiction itself,” said Madhukar H. Trivedi , MD, of the University of Texas Southwestern Medical Center, Dallas, who led the trial. “The good news is that some of the structural and neurochemical changes in the brain are reversed in recovering people, which underscores the importance of identifying new and more effective treatment strategies.”
Methamphetamine use disorder is a serious illness often associated with serious medical and mental health complications and a risk of fatal overdose. Methamphetamine is a potent stimulant and, like other addictive drugs, it hijacks reward pathways in the brain by increasing levels of dopamine, a brain chemical associated with repeated actions that cause pleasurable feelings.
Finding treatments that disrupt these processes has been a challenge for scientists. Research suggests that bupropion may alleviate dysphoria associated with methamphetamine withdrawal by acting on the dopaminergic and noradrenergic systems. Relief from dysphoria can in turn reduce cravings and help prevent a return to methamphetamine use. Naltrexone may reduce the euphoric effects and cravings associated with taking methamphetamine. In previous clinical studies, however, bupropion and naltrexone taken alone have shown limited and inconsistent efficacy in the treatment of methamphetamine use disorders. However, in combination, these compounds seem to have an additive or synergistic effect.
While there are drugs approved by the United States Food and Drug Administration for other substance use disorders, no drug has yet received FDA approval for disorders related to substance use. use of methamphetamine. The effectiveness of this combination of drugs is a step towards improving the treatment of this addiction.
The researchers recommend that future research build on this work by testing whether longer treatment with naltrexone / bupropion or concomitant behavior therapy, such as contingency management, provides even better answers. Contingency management, which uses motivating incentives and tangible rewards to help a person meet their treatment goals, has been shown to be the most effective therapy for stimulant use disorders, but it does not. is not widely used, in part due to a policy limiting the monetary value of permitted incentives. as part of the processing.
About the National Institute on Drug Abuse (NIDA): NIDA is a component of the National Institutes of Health, US Department of Health and Human Services. NIDA supports most of the world’s research on the health aspects of drug use and addiction. The Institute conducts a wide variety of programs to inform policy, improve practice, and advance the science of addiction. For more information about NIDA and its programs, visit www.drugabuse.gov.
About the National Institutes of Health (NIH):NIH, the country’s medical research agency, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.
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