Ketamine Therapy for Alcohol Use Disorder (AUD): A Review of 2022 Awakn Phase II Trial

What is Alcohol Use Disorder (AUD)?

AUD, also referred to as alcohol abuse, alcohol dependence, and alcohol addiction is a medical disorder characterized by an impaired ability to stop or control use of alcohol despite adverse social, occupational or health consequences. AUD is considered a brain disorder with a spectrum of severity ranging from mild, moderate, and severe. Long lasting changes in the brain from AUD make individuals highly susceptible to relapse when attempting to abstain from use.

In the US, an estimated 14 million adults ages 18 and older suffer from AUD in 2019, while among the youth, greater than 400,000 adolescents suffer from AUD. Rates of relapse with traditional treatment methods including medications, psychological therapy, and support groups (i.e., alcoholics anonymous) are high, with 75% of individuals relapsing within the first 12 months of treatment.

Risk for AUD

• Drinking at an early age: Individuals who began drinking before age of 15 are 5 times more likely to develop AUD than those who waited until age of 21
• Genetic and family history of alcohol problems
• Mental health conditions and history of trauma: This includes depression, PTSD, and ADHD; people with childhood trauma are more susceptible to AUD

Trial design

The double-blind placebo-controlled trial included 96 patients with severe AUD, who were randomized to one of four groups:

1. Three ketamine infusions (0.8 mg/kg IV over 40 minutes) plus psychological therapy
2. Three saline infusions plus psychological therapy
3. Three ketamine infusions plus alcohol education
4. Three saline infusions plus alcohol education

Results

The primary outcome of the trial was days abstinent in 6 months after treatment and rate of relapse at 6 months follow up. Findings showed 86% rate of abstinence in group of patients that received Ketamine + psychological therapy, in comparison to 38% rate of abstinence in group of patients that received industry standard treatments of AUD. The rate of relapse at 6 month follow up was 2.5 times less than the group that received just therapy.

Secondary outcomes included significant reduction in depression scores for those suffering from major depressive disorder, significant improvements in liver function tests, and decrease rate of anhedonia (the inability to experience pleasure). Perhaps an equally powerful outcome was the significantly reduced rate of mortality observed in the group that received ketamine.

There was also a significant decrease in the risk of mortality, 1 in 8 patients would have died within 12 months without treatment, that number decreased to 1 in 80 following the treatment.

Conclusion

It is very encouraging to see such positive results of this trial with the use of ketamine for the treatment of alcohol use disorder. This could lead to a radical shift in how we treat AUD for those who have struggled or failed to find relief from standard methods of alcohol abstinence. Awakn is preparing to launch its Phase 3 trial, which will be funded by the UK National Health Service. If this Phase 3 trial replicates these results, then FDA approval is likely to follow with hundreds of millions of people with alcohol addiction gaining access to ketamine-assisted therapy and importantly, being gifted hope. At Innerbloom Ketamine Therapy, we have helped many patients with alcohol abuse disorder and have seen firsthand how successful ketamine can be to help patients stay sober and develop a new relationship with alcohol.