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Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence.

Research output: Contribution to journalArticle

Kim Donoghue, Abigail Rose, Simon Coulton, Rachel Coleman, Joanna Mercedes Milward, Thomas Philips, David Colin Drummond, Hilary Little

Original languageEnglish
JournalTrials
Volume21
Issue number796
Accepted/In press5 Sep 2020
Published16 Sep 2020

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Abstract

Background: Alcohol dependence is a significant issue contributing to disease burden. Changes in cortisol concentrations during alcohol withdrawal are associated with cognitive deficits and symptoms of depression. Current treatments are only successful for a small proportion of people and do not target cognitive deficits and symptoms of depression experienced by those who are alcohol dependent. The aim of this research is to determine the potential efficacy of mifepristone, a type II glucocorticoid receptor antagonist, to prevent symptoms of depression and cognitive deficits following alcohol detoxification.
Methods: This was a Phase 2 therapeutic use trial. It was a double-blind randomised controlled clinical trial of mifepristone versus inactive placebo treatment. The trial aimed to recruit 120 participants who met the inclusion criteria; 1) Male, 2) Aged 18-60 years inclusive, 3) alcohol dependent for 5 or more years. Participants were randomised to 600 mg a day mifepristone (200 mg morning, afternoon and evening) for 7 days and 400 mg for the subsequent 7 days (200 mg morning and evening) or the equivalent number of placebo tablets for 14 days. Primary outcome measures were cognitive function (measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB)) and symptoms of depression (measured using the Beck Depression Inventory (BDI)) at four weeks post randomisation.
Results: Difficulties recruiting participants due to significant changes in the provision of inpatient care for alcohol dependence resulted in only 27 participants recruited to the trial, with data available for 21 participants. Fourteen participants were randomised to receive mifepristone and 13 to receive placebo.
Conclusion: Larger trials would be needed to draw conclusions about the efficacy of mifepristone.

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