Phase II a/b results
Conclusions
Primary Outcomes
1. KARE therapy significantly increased abstinence over all other groups.
2. Odds ratio of relapse was reduced with the KARE therapy.
Secondary Outcomes
1. Ketamine groups showed improved liver function across several markers.
2. Ketamine groups saw reduced depression and anhedonia (inability to experience pleasure) at 3 months.
Exploratory Analysis
Heavy drinking days were reduced in the KARE group compared to all other groups.
Safety
Ketamine was well tolerated and had a good safety profile, adverse events were predominantly mild and only reported by 8/96 patients. No serious adverse events happened.
Phase II a/b (KARE) results:
THE RESEARCH QUESTION
Can Ketamine-Assisted Therapy increase abstinence rates in patients with Alcohol Use Disorder following detox?
Details of Phase II a/b (KARE)
Phase II a/b (KARE) Trial Design
Phase II a/b (KARE) Treatment Protocol
The treatment protocol took place over 4 weeks and consisted of 7 therapy sessions of 1.5hrs long each, and three ketamine sessions.
A Qualitative Study of Patients’ Experiences:
“This Is Something That Changed My Life”
In conjunction with the KARE study, a further study was conducted on the qualitative patient outcomes during the trial. This has also been published in Frontiers in Psychiatry, click here for the full paper.
Aim
The study aimed to examine participant experiences of ketamine infusions and how these relate to therapeutic mechanisms in a clinical trial setting.
Conclusion
Provided in a supportive and professional environment, ketamine treatment led to a significant change in their relationship with alcohol. Ketamine induced ego dissolution and dissociation were reported to be related to the transformational effects on relationship with alcohol.
PATIENT EXTRACTS
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