News Release
Wednesday 13 January 2021
A combination of two medications, injectable naltrexone and oral bupropion, was safe and effective in treating adults with moderate or severe methamphetamine use disorder in a double-blind, placebo-controlled phase III clinical trial. The findings suggest that this combination therapy may be a promising addition to current approaches to treatment, such as cognitive behavioral therapy and contingency management interventions, for a very serious condition that remains difficult to treat and overcome. The research, conducted today in The New England Journal of Medicine, has been conducted at various sites in the National Institute for Drug Abuse Clinical Trials Network (NIDA CTN). NIDA is part of the National Institutes of Health.
‘The opioid crisis and the consequent deaths from overdose in the United States are now well known, but what is less acknowledged is that there is a growing crisis of overdose deaths that includes methamphetamine and other stimulants. Unlike opioids, however, there is currently no approved drug for the treatment of methamphetamine disorder, “said NIDA Director Nora D. Volkow, MD. This advance shows that medical treatment for the disorder methamphetamine can help improve the patient’s outcomes. “
The study, known as the Accelerated Development of Complementary Pharmacotherapy Treatment for Methamphetamine Use Disorder, or ADAPT-2, was conducted from 2017 to 2019 at clinics in various community treatment programs nationwide and enrolled 403 adult volunteers aged 18 to 65 with moderate to severe. methamphetamine use disorder. All participants wanted to reduce or discontinue use of the drug and were randomly assigned to the treatment or control group.
At every two stages of six weeks, volunteers in the treatment group were given an injection of naltrexone with prolonged release, a drug used to treat opioids and alcohol use, and took tablets of bupropion, an antidepressant, daily. also used as a treatment to promote the cessation of nicotine. Those in the control group received corresponding injectable and oral placebos during the same time period. Investigators conducted four urine drug screens at the end of each stage of the trial. Participants were considered to respond to treatment if at least three of the four urine screens were negative.
Overall, participants in the treatment group responded significantly higher. When selected during weeks five and six, 16.5% of those receiving the naltrexone / bupropion combination responded, compared with only 3.4% of those in the control group. Similarly, when 11.4% of the treatment group was selected in weeks 11 and 12, it responded, compared to 1.8% of the control group. Researchers have calculated that the number of treatments required (NBT) is 9. NBT is a way of describing the usefulness of a medical intervention that indicates how many people need treatment for it to benefit one person. The investigators reported that, with a NNT of 9, the benefit of naltrexone / bupropion as a treatment for methamphetamine use disorder is similar to most medical treatments for mental illness, including antidepressants prescribed for depression or naltrexone prescribed for alcohol use.
Participants in the treatment group had fewer desires than those in the placebo group and reported greater improvements in their lives, measured by a questionnaire called the Treatment Effectiveness Assessment. Importantly, there were no significant adverse effects associated with the treatment of dual medication. Compliance with treatment was encouraged by compliance with counseling and reminders for mobile applications and remained high at 77.4% and 82.0% in the treatment and placebo groups in the last six weeks of the study.
“Prolonged abuse of methamphetamine has been shown to cause diffuse changes in the brain, which can contribute to serious health consequences beyond addiction itself,” said Madhukar H. Trivedi, MD, of the University of Texas, Southwestern Medical Center, Dallas, which led, said. the court case. “The good news is that some of the structural and neurochemical brain changes are reversed in people who recover, and this underscores the importance of identifying new and more effective treatment strategies.”
Methamphetamine use disorder is a serious illness that is often associated with serious medical and mental health complications and the risk of fatal overdose. Methamphetamine is a powerful stimulant, and, like other addictive drugs, it cuts the reward pathways in the brain by increasing levels of dopamine, a chemical in the brain associated with repeated actions that cause pleasant feelings.
It has been difficult for scientists to find treatments that disrupt these processes. Research suggests that bupropion can alleviate dysphoria associated with methamphetamine withdrawal by acting on the dopamine and norepinephrine systems. Reducing dysphoria can again reduce cravings and help prevent recurrence of methamphetamine use. Naltrexone can reduce the euphoric effects and cravings associated with methamphetamine use. In previous clinical studies, both bupropion and naltrexone alone, have shown limited, inconsistent efficacy in the treatment of methamphetamine use disorder. In combination, these compounds appear to have an additive or synergistic effect.
While there are US drug-approved drugs for other substances, there is still no FDA approval for the use of methamphetamine. The effectiveness of this medication combination is to improve the treatment of this addiction.
The investigators recommend that future research build on this work by testing whether longer treatment with naltrexone / bupropion or concomitant behavioral therapy, such as contingency management, provides even better responses. Contingency management, which uses motivational incentives and tangible rewards to help a person achieve their treatment goals, is the most effective therapy for stimulating use disorders, but is not widely used, in part because of a policy that limits the monetary value of permissible incentives. . as part of the treatment.
About the National Institute on Drug Abuse (NIDA): NIDA is part of the National Institutes of Health, the 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 implements a wide range of programs to inform policy, improve practice, and promote addiction science. Visit www.drugabuse.gov for more information on NIDA and its programs.
About the National Institutes of Health (NIH):
NIH, the country’s medical research agency, contains 27 institutes and centers and is part of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, investigating the causes, treatments, and drugs for common and rare diseases. Visit www.nih.gov for more information on NIH and its programs.
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