Alcoholism MedDRA version: 18.0 Level: PT Classification code 10001639 Term: Alcoholism System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Mifegyne
Product Name: Mifepristone
Pharmaceutical Form: Tablet
INN or Proposed INN: MIFEPRISTONE
CAS Number: 84371653
Sponsors
Kings College London
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (i) diagnosis of alcohol dependence by DSM-IV for 5 years or more (ii) male (iii) aged between 18 and 60 years (inclusive) (iv) willingness to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria will be (i) clinical diagnosis of a neuroendocrine disorder, (ii) liver damage, determined by alanine aminotransferase (ALT) activity of more than 2.5 x normal range, (iii) renal dysfunction, as determined by creatinine levels over 150 umol/L in plasma samples taken prior to admission to the Alcohol Unit (iv) documented evidence of a psychotic disorder (v) severe brain damage or severe mental impairment, (vi) diagnosis of severe physical illness that would preclude participation (e.g. terminal illness), (vii) documented evidence of current dependence on a substance other than alcohol or nicotine (viii) inability to understand sufficient english to understand the information needed for the cognitive testing (ix) female gender (x) 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 (xi) porphyria (xii) severe asthma uncontrolled by therapy (xiii) cardiac disorders i.e. myocardial infarction, congestive cardiac failure or cardiomyopathy (xvi) Has persistent high blood pressure (over 160 mmHg systolic and/or 100 mmHG diastolic on both of two readings at initial screening session) (xv) medical history of diabetes (xvi) known allergy to mifepristone (xvii) owing to potential interactions with mifepristone, participants taking the following drugs will be excluded: ketoconazole, itraconazole, metronodazole, miconazole, erythromycin, clarithromycin, rifampin, rifabutin, norfloxacin, nelfinavir, ritonavir, saquinavir, zafirlukast, fluvoxamine, quinine, phenytoin, phenobarbital, primadone, carbamazepine, amiodarone, warfarin, corticosteroids or St John's Wort. Consumption of grapefruit juice is also contraindicated during mifepristone treatment
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): severity of the acute phase of alcohol withdrawal, alcohol craving and symptoms of protracted withdrawal including sleep disturbances;Timepoint(s) of evaluation of this end point: The analysis on the data from the follow-up studies will be carried out when all the data from these have been collected, or in the case of difficulties in contacting for follow-up interviews, when the 12 month interval has passed for the last participant | — |
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Does the drug, mifepristone, reduce the amount or frequency of relapse drinking in abstinent alcoholics?; Primary end point(s): Cognitive ability as measured by the CANTAB test battery Depressive symptoms, as measured by the Beck depression scale ;Main Objective: Does the action of the drug, mifepristone, in preventing the effects of the naturally released glucocorticoid hormone cortisol on the Type II glucocorticoid receptor reduce the cognitive deficits and/or the depression experienced by alcoholics?; Timepoint(s) of evaluation of this end point: CANTAB - Days 13 and 20 inclusive and between Days 21 and 28 inclusive Beck Depression Inventory (BDI-II) will record depressive symptoms every 7 days (± 2 days) for four weeks, starting one week after detoxification. The BDI-II will also be administered in Week 3, 4 and at the 3, 6 and 12 month follow up appointments. | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Colin Drummond
Institute of Psychiatry, King's College London
Outcome results
None listed