Awakn Expands Its Ketamine Trial For Alcohol Use Disorder
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A first-of-its-kind phase 3 trial will soon begin in the UK to test whether ketamine can help treat patients with alcohol use disorder (AUD).
The study will take place across seven sites in the UK, all run by the country’s National Health Service (NHS), and will be partly funded by a grant from the National Institute for Health and Care Research (NIHR), a UK government agency.
The rest of the funding will be provided by Awakn, the biotechnology company spearheading the study.
Ketamine, not cocktails
Despite the adverse medical and economic harms associated with AUD, few patients receive medication to treat their disorder. And these medications are limited; no new compounds for treating AUD have been approved by the US Food and Drug Administration (FDA) since 2004.
In an attempt to provide a new, effective treatment, Awakn has partnered with the University of Exeter’s Celia Morgan, a professor of psychopharmacology, to test the potential benefits ketamine-assisted therapy could offer AUD patients.
“More than two million UK adults have serious alcohol problems, yet only one in five of those get treatment,” Morgan said in a statement.
“Unfortunately, three out of four people who quit alcohol will be back drinking heavily after a year. Alcohol-related harm is estimated to cost the NHS around £3.5 billion each year, and wider UK society around £40 billion. Alcohol problems affect not only the individual but families, friends and communities, and related deaths have increased still further since the pandemic. We urgently need new treatments. If this trial definitively establishes that ketamine and therapy works, we hope we can begin to see it used in NHS settings.”
Morgan aims to recruit 280 patients with AUD for the trial. These participants will be randomly allocated into two groups. Half will be given ketamine and receive psychological therapy. The other half will be given a very low dose of ketamine and a seven-session education package about the harmful effects of alcohol.
The trial follows on from its phase 2 predecessor – also led by Professor Morgan – which resulted in its participants experiencing an average 86% abstinence rate six months on from treatment; abstinence rates were, on average, 2% prior to the trial.
The phase three trial will focus on establishing “further definitive evidence” of ketamine’s efficacy and move towards the novel treatment being licensed for this indication, according to Awakn.
It is expected to be the largest ketamine-assisted therapy clinical trial to date and the only phase three psychedelic clinical trial ever to receive government funding. “For this phase III to have the support and funding from the NIHR and for it to be delivered in the NHS is a great endorsement of this treatment’s potential and a sign of how badly a new more effective treatment is needed to help the millions of people suffering from Alcohol addiction in the UK,” Anthony Tennyson, Awakn’s CEO, said in a statement.
“We are very proud to be part of this important piece of work. With two Awakn clinics already open in the UK and more in Europe we are already seeing the incredible benefits of this treatment for our clients on an off-label basis.”
Awakn’s belief in the powers of ketamine extends beyond AUD; the company has also run trials to see whether the drug can help treat gambling addiction, binge eating disorder, compulsive sexual behavior, and internet gaming disorder.
Speaking to Analytical Cannabis last year on Awakn’s gambling disorder study, Professor Morgan – who ran this trial, too – explained the study’s design and why her team aimed to test ketamine’s potential as a behavior-disrupting drug.
“We are using one of the capacities of the ketamine which is to block a process of re-stabilization of memory. In the study that we’re doing, we’re going to reactivate gambling memories. We’ll be showing people, depending on what their modality of gambling is, a roulette wheel or slot machines or horses, and this reactivates the memory,” she said.
“Normally in memory, this means that this memory becomes active and you’re able to update it. Then it’s restabilized – saved again, in computer terms – and is laid down more strongly. If you give ketamine during this time of reactivation, what’s been found particularly in animals is that this can weaken the memory trace. That’s what we’re looking at in this study.”