Contact information
Type
Scientific
Primary contact
Prof Hilary Little
ORCID ID
Contact details
St George's
University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
-
hilary.little@sgul.ac.uk
Additional identifiers
EudraCT number
2009-015837-55
ClinicalTrials.gov number
Protocol/serial number
9272
Study information
Scientific title
Glucocorticoid receptor antagonism and cognition in alcoholics
Acronym
MIFCOG
Study hypothesis
This trial investigates whether treatment with mifepristone reduces cognitive impairment and depressive symptoms in alcohol dependent inpatients undergoing detoxification.
Ethics approval
ref: 10/H0808/7
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
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 trial start date
01/10/2011
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
Participant 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
Recruitment start date
01/10/2011
Recruitment end date
31/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George's, University of London
London
SW17 0RE
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute Of Psychiatry
16 De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26912003