A Phase III Trial Investigating the Effects of Ketamine-Assisted Therapy in the Treatment of Alcohol Use Disorder

Following positive Phase II results, Awakn Life Sciences has announced a Phase III trial to explore the effects of ketamine-assisted therapy in the treatment of alcohol use disorder (AUD).

Similar to Phase II, the trial is being led by Professor Celia Morgan at the University of Exeter. The trial is set to recruit 280 participants with severe AUD, randomized into two groups. Half will be given ketamine with the proprietary psychological therapy developed for the Phase II trial. 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 has received funding for 66% of the costs from the National Institute for Health and Care Research (NIHR), a UK government agency.

Topic Alcohol Use Disorder Addiction
Compound Ketamine
Country United Kingdom
Visit trial
Status Planned
Results Published No
Start date 01 May 2023
End date 01 May 2023
Chance of happening 89%
Phase Phase III
Design Blinded
Type Interventional
Generation First
Participants 280
Sex All
Age 18- 99
Therapy Yes

Trial Details

Half of the 280 participants will be given ketamine with the proprietary psychological therapy developed for the Phase II trial. 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 Phase III trial will focus on establishing further definitive evidence and move towards the novel treatment being licensed for this indication

NCT Number

Sponsors & Collaborators

Awakn Life Sciences
AWAKN Life Sciences aims to bring psychedelics therapy to the UK. Under this company fall three arms; psychedelic research, clinic platform, and practitioner training.

Papers

Adjunctive Ketamine With Relapse Prevention–Based Psychological Therapy in the Treatment of Alcohol Use Disorder
This double-blind placebo-controlled trial (n=96) assessed the effectiveness of 1) three weekly ketamine infusions (56mg/70kg i.v. over 40 minutes) plus psychological therapy, 2) three saline infusions plus psychological therapy, 3) three ketamine infusions plus alcohol education, or 4) three saline infusions plus alcohol education, in people with alcohol use disorder (AUD). Participants in the ketamine groups abstained from alcohol for a significantly longer number of days at 6-month follow-up, while the greatest abstinence was in the ketamine plus therapy group. Relapse times did not differ across the four groups.

Data attribution

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