Ketamine for Reduction of Alcoholic Relapse (KARE)

96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3 sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3 and 6 months on a range of psychological and biological variables. Primary endpoints will be % days abstinent at 6 months and relapse rates at 6 months. Secondary endpoints include depressive symptoms, craving, quality of life.

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Status Completed
Start date 10 October 2016
End date 10 February 2020
Chance of happening 100%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 96
Sex All
Age 18- 60
Therapy Yes

Trial Details

96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3 sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3 and 6 months on a range of psychological and biological variables. Primary endpoints will be % days abstinent at 6 months and relapse rates at 6 months. Secondary endpoints include depressive symptoms, craving, quality of life.

NCT Number NCT02649231

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.

University College London
In October 2021, the Understanding Neuroplasticity Induced by Tryptamines (UNITY) Project was launched at University College London.

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 (0.8 mg/kg 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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