NIH study uncovers the potential benefits of the combination treatment including two medications, injectable naltrexone and oral bupropion, was found safe and effective in treating adults with moderate or severe methamphetamine use disorder.
The findings of the research study 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), National Institutes of Health NIH.
News: Combination treatment for methamphetamine use disorder shows promise in NIH study https://t.co/Kz2nZbSKUx
— NIH (@NIH) January 13, 2021
In the double-blind, placebo-controlled Phase III clinical trial study, results suggest that this combination therapy approach is promising to current approaches to treatment, such as cognitive behavioral therapy and contingency management interventions, for such serious condition that remains difficult to treat and overcome.
In U.S, the opioid crisis and subsequent mortality rates are not well known. However, the growing crisis of overdose deaths involving methamphetamine and other stimulants is less recognized and currently, other than opioids, there are currently no approved medications for treating methamphetamine use disorder.
NIDA Director Nora D. Volkow, M.D., said, “This advance demonstrates that medical treatment for methamphetamine use disorder can help improve patient outcomes.”
Methamphetamine use disorder is such a ravaging condition.
I’ve seen it drastically increase among my patients over the past 5 years as it’s become cheaper.
While this study shows a modest effect, it’s at least a pharmacological option to consider where we don’t have any.
— Dr. Jonathan N. Stea (@jonathanstea) January 14, 2021
Methamphetamine use disorder is considered a serious illness often associated with severe medical and mental health complications and a risk of fatal overdose. Methamphetamine is considered a potent stimulant, like other addictive drugs, invades and hijacks the reward pathways in the brain by raising levels of dopamine – a brain chemical associated with repeating actions that cause pleasurable feelings.
The study known as the “Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder study”, ADAPT-2, was carried out between 2017 to 2019, at clinics in multiple community treatment programs, nationwide. It enrolled 403 adult volunteers aged 18 to 65 years with moderate to severe methamphetamine use disorder.
Volunteers in the treatment group were given injection of extended-release naltrexone, a drug used to treat opioid and alcohol use disorders, every three weeks and took daily extended-release tablets of bupropion, an antidepressant also used as a treatment to aid nicotine cessation.
For six-week stages, they were given this regimen while those in the control group were given matched injectable and oral placebos over the same time period.
Following, the participants performed four urine drug screens at the end of each stage of the trial. If 3 out of 4 screens tested negative, participants were considered to have responded to treatment. Results revealed that overall, participants responded at a significantly higher rate in the treatment group. When screened during weeks five and six, 16.5% of those given the naltrexone/bupropion combination responded, relative to only 3.4% from the control group.
It was found that those individuals who volunteered for the treatment group, were found to have fewer cravings than those in the placebo group, and they also revealed an improve lifestyle as measured by a questionnaire called the Treatment Effectiveness Assessment.
Notably, the combination treatment of both medications did not show any serious side effects.
“Long-term methamphetamine misuse has been shown to cause diffuse changes to the brain, which can contribute to severe health consequences beyond addiction itself,” said Madhukar H. Trivedi, M.D., of the University of Texas Southwestern Medical Center, Dallas, who led the trial.