Effect of MIFepristone on COGnitive impairment in alcoholics

ISRCTN	ISRCTN54001953
DOI	https://doi.org/10.1186/ISRCTN54001953
EudraCT/CTIS number	2009-015837-55
Secondary identifying numbers	9272

Submission date: 29/09/2011
Registration date: 29/09/2011
Last edited: 18/09/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hilary Little
Scientific

St George's, University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

Email	hilary.little@sgul.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Glucocorticoid receptor antagonism and cognition in alcoholics
Study acronym	MIFCOG
Study objectives	This trial investigates whether treatment with mifepristone reduces cognitive impairment and depressive symptoms in alcohol dependent inpatients undergoing detoxification.
Ethics approval(s)	ref: 10/H0808/7
Health condition(s) or problem(s) studied	Addictions; Disease: Addictive Substances alcohol
Intervention	There will be 120 participants, 60 in each treatment group. Mifepristone or placebo will be administered for 14 days starting on the first day of admission. Mifepristone, Adjunctive treatment with mifepristone (600 mg/day for 7 days followed by 400mg/day for 7 days) versus placebo. Cognitive testing will be conducted at the end of treatment. Follow-up contacts will be 3, 6 and 12 months to determine whether each participants has maintained abstinence or relapsed back into alcohol drinking. Follow Up Length: 12 month(s); Study
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Mifepristone
Primary outcome measure	Cognitive performance; Timepoint(s): One week after cessation of treatment
Secondary outcome measures	Depression symptoms; Timepoint(s): Baseline and weekly for trial duration
Overall study start date	01/10/2011
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	Planned Sample Size: 120; UK Sample Size: 120
Total final enrolment	27
Key inclusion criteria	1. Diagnosis of alcohol dependence by DSM-IV for at least 5 years 2. Male 3. Aged under 60 4. Willingness to provide informed consent The study will be limited to males because of the progesterone antagonist properties of mifepristone. The minimum duration of dependence will optimise incidence of cognitive deficits, whilst the upper age limit will minimise the contribution of age-related deficits.
Key exclusion criteria	The following conditions affect HPA function and are common in the alcoholic population: 1. Depressive disorders 2. Smoking 3. Hypertension 4. Obesity 5. Liver disease 6. Kidney disease 7. Post traumatic stress disorder 8. Mental illness 9. Brain damage 10. Comorbid substance dependence While we shall make the exclusions detailed below, to omit all these disorders would render the majority of the inpatient subject population ineligible, which would affect the external validity of the research and limit the examination of the role of the glucocorticoid Type II receptor. We therefore propose to include those with less severe forms of these disorders, to document the symptomatology carefully, and to analyze possible influences of these disorders on the variables under study. Exclusion criteria: 1.Clinical diagnosis of a neuroendocrine disorder 2. Liver damage, determined by alanine aminotransferase (ALT) activity of more than 2.5 x normal range 3. Renal dysfunction 4. Psychotic disorder that would limit valid provision of informed consent (ICD-10 diagnosis from the CIDI) 5. Severe brain damage or severe mental impairment 6. Diagnosis of severe physical illness that would preclude participation (e.g. terminal illness) 7. Inability to understand sufficient english to take understand the information needed for the cognitive testing 8. Female gender 9. Patients with Korsakoff's/Wernicke's syndromes (less than 2% in our Treatment Unit) will not be included because the cognitive deficits are considered to be permanent and due primarily to thiamine deficiency 10. Porphyria 11. Asthma 12. Owing to potential interactions with mifepristone, participants taking the following drugs will be excluded: ketoconazole, itraconazole, metronodazole, miconazole, erythromycin, clarithromycin, troleandomycin, rifampin, rifabutin, norfloxacin, nefadazone, nelfinavir, ritonavir, saquinavir, omeprazole, zafirlukast, fluvoxamine, quinine, phenytoin, phenobarbital, primadone, carbamazepine, troglitazone, amiodarone, warfarin, indomethacin, aspirin, corticosteroids or St John's Wort. Consumption of grapefruit juice is also contraindicated during mifepristone treatment
Date of first enrolment	01/10/2011
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St George's, University of London

London
SW17 0RE
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute Of Psychiatry
16 De Crespigny Park
London
SE5 8AF
England
United Kingdom

Website	http://www.kcl.ac.uk/
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	24/02/2016		Yes	No
Basic results			28/05/2020	No	No
Results article	results	16/09/2020	18/09/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

18/09/2020: Publication reference added.
28/05/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
12/12/2018: No publications found, verifying study status with principal investigator.
25/02/2016: Publication reference added.