Effect of MIFepristone on COGnitive impairment in alcoholics

Phase 3

Completed

• Conditions: Addictions; Disease: Addictive Substances alcohol; Mental and Behavioural Disorders; Mental and behavioural disorders: alcoholism

• Registration Number: ISRCTN54001953
• Lead Sponsor: King's College London (UK)

Brief Summary

2016 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26912003 2020 results in https://pubmed.ncbi.nlm.nih.gov/32938477 (added 18/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-29
• Study Completion: 2014-12-31
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 27

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.

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified