Abstract
BackgroundAlcohol 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.MethodsThis 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, and (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 4 weeks post-randomisation.ResultsDifficulties 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.ConclusionLarger trials would be needed to draw conclusions about the efficacy of mifepristone.Trial registrationISRCTN registry ISRCTN54001953. Registered on 29 September 2011.
Highlights
Alcohol dependence is a significant issue contributing to disease burden
Greenfield et al [13] found that those entering inpatient treatment for alcohol dependence who had a diagnosis of major depression had a shorter time to first drink and relapse in the first year following treatment
Study population and recruitment difficulties Recruitment for the trial began in September 2012, and the final participant follow-up assessment took place in July 2016
Summary
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. Impairment in cognitive function is found in 50 to 80% of those dependent on alcohol with impairment experienced across multiple domains including memory, attention, learning, processing speed, visuospatial abilities, and executive function [5, 6]. These impairments may hinder an individual’s quality of life and their ability to benefit from treatment programmes [7,8,9,10,11]. Greenfield et al [13] found that those entering inpatient treatment for alcohol dependence who had a diagnosis of major depression had a shorter time to first drink and relapse in the first year following treatment
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