A clinical trial with nearly 100 participants is currently underway to investigate whether low-dose ketamine along with psychotherapy might help heavy drinkers in remission stay sober, and the results, published in the American Journal of PsychiatryThey are hopeful.
Results from the phase II trial, called Ketamine for Alcohol Relapse Reduction (KARE), suggest that the combination therapy may be more effective than existing addiction treatments.
The researchers plan to test this extensively in a phase III trial, which would include many more people. And if it’s successful, it could become the first new treatment for alcoholism in decades.
This phase II clinical trial is the first of its kind to test whether a low dose of ketamine, combined with individual therapy sessions, can prevent people from returning to heavy drinking immediately after quitting. Compared to a control group that did not receive ketamine, participants were 2.5 times more likely to abstain from drinking until the end of the trial.
According to Celia Morgan, a professor of psychopharmacology at the University of Exeter in the UK and lead author of the study, ketamine changes the way people think, allowing them to see old problems in a new way.
“It makes the brain more receptive to new learning by stimulating a process called synaptic plasticity, in which the brain is better able to make new connections,” Morgan told reverse.
What ketamine essentially does in the brain is effectively block a receptor that helps neurons send messages to other neurons. According to previous research, this particular receptor plays a key role in learning and memory, and changes in the receptor can influence behaviors related to addiction, including future behavior patterns.
Why are they doing the ketamine studies?
Ketamine is the only psychedelic approved by the US Food and Drug Administration (FDA). In fact, the agency approved ketamine nasal spray for treatment-resistant depression in 2019. But according to a growing body of research, ketamine may also help treat other mental health conditions, including addiction, post-traumatic stress disorder (PTSD) and suicidality, when existing treatment options have failed.
According to Morgan, ketamine “is a dissociative anesthetic, so we tend to see it as something that distances people. But our interviews with patients suggested that feeling detached from themselves made them feel more connected to the world around them and this helped them recover from alcohol.”
To understand the implications, consider that people in the ketamine plus therapy group only drank heavily on five days over a six-month period. By drastically reducing their alcohol intake, ketamine-assisted therapy also lowered their risk of alcohol-related death from one in eight to one in 80 during that time.
“We are certainly not advocating taking ketamine outside of a clinical context. Street drugs carry obvious risks, and the combination of low-dose ketamine and appropriate psychological therapy is key, as is the experience and support of clinical staff. This combination showed benefits, still being seen six months later, in a group of people for whom existing treatments just don’t work,” Morgan said.
Who is participating in the study?
The study includes 96 people with moderate to severe alcohol use disorder who did not drink during the trial. In fact, to be included in the study, participants had to completely abstain from drinking for at least 24 hours before being selected for the trial.
On average, the participants consumed 125 units of alcohol per week, which is equivalent to about 63 beers (one unit is the amount of alcohol the average person can metabolize in one hour). Forty-five percent of the participants also had an anxiety disorder and 40 percent had depression.
Participants in the trial were divided into four separate groups. Some people received seven sessions of alcohol education or therapy and no ketamine, and others received up to three ketamine infusions combined with alcohol education or therapy.
The study showed that those who received ketamine combined with therapy remained completely sober for 162 of the 180-day follow-up period (equivalent to 87 percent of days), which was significantly higher than any of the other groups. Those in either ketamine group also reported lower depression after three months and better liver function than those taking placebo.
Taken together, the results suggest that ketamine infusions, combined with more traditional therapy, could help prevent relapse after people stop drinking.
Given the success of the trial, Morgan’s team is now ready to move on to a phase III clinical trial, in which they will repeat the study on a larger scale, with more people, to validate the results.
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