A new study reveals that a generic drug that has been used to treat heart failure and high blood pressure for decades has early potential as treatment for alcohol use disorder.
Called spironolactone, this pill costs just pennies for a day, and is often prescribed as a diuretic to lessen fluid retention in people with heart failure. This medication works by blocking proteins, which are known as mineralocorticoid receptors, that are located all throughout the body. One of their functions is to help maintain a healthy balance of electrolytes and fluids in the body. Moreover, in former lab experiments, results have shown that these proteins may also play a role in alcohol use.
During the new study, the research team tested the effects of the spironolactone pill in rats and mice. After which, they studied the medical records of over two million people that drink alcohol to see if taking the drug was linked with reduced alcohol consumption.
According to the study results that were published in Molecular Psychiatry, when both the humans and rodents took spironolactone, they drank significantly less.
Co-senior study author from the National Institute on Drug Abuse (NIDA) in Baltimore, Leandro Vendruscolom, PharmD, PhD, “The available treatments are not effective for all people with alcohol use disorder — one size does not fit all. More medications will help with the treatment of more people with alcohol use disorder.”
A Need for Other Drugs to Help Treat Alcohol Use Disorder
According to the National Institute on Alcohol Abuse and Alcoholism (NIAAA), most Americans will eventually drink at some point in their lifetime. And statistics show that around 1 in 20 people will evolve into alcohol use disorder. Despite the large numbers, less than 1 in 10 people get treatment for their alcohol disorder.
As shared by the NIAAA, there are only three drugs currently approved by the U.S. Food and Drug Administration (FDA) that can be used to treat alcohol use disorder. These are naltrexone, which works to block receptors in the brain that are known to play a key role in alcohol cravings and the rewarding sensations that come along with drinking. The second is acamprosate, which works to reduce the cravings and withdrawal symptoms when people stop drinking. And the third is disulfiram, a drug that helps encourage abstinence by causing nausea and other disagreeable symptoms that tend to come when people drink.
Although he was not part of the study, Professor of psychiatry and director of the Center for Studies of Addiction at the University of Pennsylvania Perelman School of Medicine in Philadelphia, Henry Kranzler, MD, said “They have only modestly better effects than placebo.”
Another drug option is called topiramate, which is an anticonvulsant, but it has yet to be approved for alcohol use disorder. But according to Dr. Kranzler, some doctors prescribe it “off-label” for this condition. Despite being more effective than the FDA-approved drugs, MedlinePlus shares that it comes with many serious side effects and should not be used with alcohol.
As explained by Dr. Kranzler, “There is a need for more effective, well-tolerated medications to treat alcohol use disorder.”
There Are Many Questions About the Safety and Effectiveness of the Drug for AUD
During the new study, it was observed that the male and female rodents that were given spironolactone, drank less alcohol than they did without consuming the drug. Moreover, the medicine didn’t seem to impact their water or food intake either. In addition, higher doses of spironolactone was also seen to result in higher reductions of alcohol consumption.
After which, the researchers looked at medical records of U.S. Veterans Affairs healthcare system to see if patients given spironolactone for its actual purpose – which is to manage high blood pressure and managing heart problems – actually drank less alcohol after they took the drug. All participants in the study said they had some alcohol consumption. Then the researchers looked for changes in the drinking habits of around 11,000 people that were prescribed spironolactone, and saw that ‘more than 34,000 people with similar patient profiles who didn’t get prescribed this drug.’
After 18 months, which is the average follow-up period, people that were taking spironolactone had a significantly reduced alcohol consumption as compared to those that didn’t take the drug. Moreover, the decrease in drinking was more notable in those on the highest doses of spironolactone, as well as those who were described as heavy drinkers.
As for the study limitations, the alcohol use was self-reported by patients, which means that there was no independent verification by lab testing. In addition, the study also wasn’t specifically designed to test the safety or effectiveness of the drug as an alcohol use disorder treatment.
There was a previous study that looked at the effectiveness of spironolactone as well. For this particular study, 523 adults that were given the drug compared their drinking habit changes over a span of six months to 2,305 adults that were prescribed the drug. For the heaviest drinkers, by the end of the study, they had reduced alcohol intake by more than four drinks a week when taking spironolactone. Again, for those that took higher doses of the meds had higher alcohol reduction. As for heavy drinkers that weren’t given spironolactone, their alcohol consumption didn’t seem to change.
Although more research is needed to verify the effectivity of spironolactone for alcohol use disorder, lead author of the previous study, Vanessa Palzes, MPH, from the Center for Addiction and Mental Health Research at the Kaiser Permanente Northern California Division of Research in Oakland, California, explained that the research that has been done has warranted larger clinical trials.
Meanwhile, co-senior author of the new study and chief of a joint NIDA and NIAA lab in the clinical psychoneuroendocrinology and neuropsychopharmacology section, Lorenzo Leggio, MD, PhD, shares that one main questions is whether larger human studies will create safety issues for people that take spironolactone and also consume alcohol.
Dr. Leggio explains, “Spironolactone has been used in clinical practice for many decades, so its safety, as well as the potential risks and side effects of this medication, are well-known.” Common side-effects include low blood pressure and lightheadedness, breast swelling or tenderness, and high potassium levels.
To date, these studies that are looking at spironolactone for alcohol use disorder haven’t shared new side effects or issues that could possibly be unique to people who are truly heavy drinkers.
Dr. Leggio shares, “However, this question is still important, given that, to our knowledge, there are no formal drug-alcohol interaction studies that have carefully examined the safety of the co-administration of spironolactone and alcohol under well-controlled conditions. Such a human study is indeed one of our next steps.”
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