Researchers in England are launching a phase 3 clinical trial to determine the effectiveness of using the drug ketamine to help treat alcohol use disorder.
The trial, organized by scientists at the University of Exeter, will involve 280 individuals with severe alcohol use disorder in seven sites across the United Kingdom.
The trial builds on research published by the Exeter team in January 2022 that suggested that low doses of ketamine, combined with psychological therapy, can help people with severe alcohol use disorder (AUD) stay sober longer.
Researchers said their clinical trial was the first of its kind to examine whether a low dose of ketamine — a drug used as an anesthetic in humans and animals — is effective in preventing relapse when used with therapy.
“Alcoholism can destroy lives, and we urgently need new ways to help people cut down,” said Celia Morgan, the study’s lead author and a professor of psychopharmacology at Exeter. “We found that controlled, low doses of ketamine combined with psychological therapy can help people stay off alcohol for longer than placebo.”
“This is extremely encouraging, as we normally see three out of every four people returning to heavy drinking within 6 months of quitting alcohol, so this result represents a great improvement,” Morgan told Healthline.
What researchers found
In the study, researchers examined 96 people with previous alcohol use issues who weren’t using alcohol at the time.
Researchers reported that the participants who had ketamine combined with therapy stayed completely sober for 162 of 180 days in the ensuing 6 months. The 87 percent abstinence was “significantly higher than any of the other groups,” researchers said.
Researchers reported the group was more than 2.5 times more likely to remain completely abstinent at the trial’s end than participants on a placebo.
“This is a very interesting study,” said Dr. Monty Ghosh, an addiction specialist and assistant clinical professor at the University of Alberta Hospital in Canada. “I think this study demonstrates there is great potential for ketamine in treating AUD. AUD is a complex disease to treat, and an approach that manages addiction cravings and mental health aspects is key, and it sounds like ketamine does target both.”
“Of note, there is no comparison trial to other forms of treatment such as naltrexone or acamprosate. Comparison trials would be important to further understand what would be the best approach for individuals with AUD,” Ghosh told Healthline.
“Another aspect to examine in the future is if ketamine helps reduce overall consumption of alcohol. Often, we’re not able to halt alcohol consumption altogether, so medications that can reduce consumption have a place in reducing the full harms of substances.
“Lastly, it’s important to note the therapeutic importance of psychosocial counseling and therapy,” Ghosh said. “This test yet again highlights why you need this.”
A close look at ketamine
Ketamine induces dissociation, providing sedation and pain relief.
Despite decades of its use as a recreational drug, momentum has picked up in recent years to explore ketamine as a treatment for depression.
Martin Preston, founder and CEO of the U.K. rehab clinic Delamere, told Healthline ketamine’s dissociative effects could be a plus for people who deal with alcohol dependence.
“Ketamine at the right levels, alongside therapy, can act as an antidepressant and help block out pain or depressive feelings that come with alcohol dependency.” Preston said. “One reason the combination of the two factors might work well together while treating alcohol dependency is that at low to moderate doses, ketamine can change our thought patterns or block the restabilization of memories that users associate as a trigger for relapse.”
“This can mean that those who are suffering from alcoholism might be more open to learning new information as part of their psychological therapy and start the healing process in a much more effective way, without being clouded by depressive thoughts of alcohol getting in the way,” he said.
Preston added that while ketamine may help short term, therapy works as a longer-term stabilizer.
“While seeing things in a different way might be a key component in addiction treatment, chemical-induced sobriety short term may not necessarily work in the long run. In our experience, those who effectively overcome alcohol disorder are those who are willing to work at their problem and continue to remain active throughout their recovery,” Preston said.
New treatments needed
Dr. Amy de la Garza, the director of substance use disorder programs at Novamind psychiatry clinics and research centers, told Healthline the time is right for new ways of approaching substance misuse.
“Since the start of the [COVID-19] pandemic we have seen a dramatic rise in risky drinking and conversion to alcohol use disorder,” de la Garza told Healthline. “We have many tools in our toolkit for treating substance use disorder… Yet, our outcomes are not improving, and in fact, our numbers are climbing upward. We need to find and utilize, with integrity, new tools to offer patients, and families, suffering with this most difficult diagnosis.”
Dr. Kurt Rasmussen, the chief science officer for Delix Therapeutics, told Healthline new treatments are “desperately needed,” and ketamine can work in the brain’s regions damaged by alcohol to helping grow neurons to heal a person’s brain.
But he also said uncontrolled use can be problematic, and it’s important that the right doses be administered, along with having the right therapist involved.
“Ketamine is a powerful drug. A good therapist will need to understand the best way to harness that power and avoid the pitfalls,” Rasmussen said. “He or she will need to know how and when ketamine affects the structure of neurons and the best time to apply psychotherapy.”
“For example, psychotherapy would need to be delivered outside the period during which ketamine’s intoxicating, dissociating consequences are in effect, but within the window of neuroplasticity in the brain,” he said.
The Centers for Disease Control and Prevention (CDC)Trusted Source says heavy alcohol use causes 95,000 deaths annually in the United States.
The agency recommends that men should not have more than two drinks a day, and women should not have more than one drink a day. For people who are pregnant or taking certain medications, they shouldn’t drink at all.
People who believe they have an alcohol use problem can contact Alcoholics Anonymous for more information on therapies and prevention.