Treatment of Hepatic Encephalopathy With Flumazenil and Change in Cortical GABA Levels in MRS

• Status: Withdrawn
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test feasibility of measuring flumazenil-induced changes in cortical GABA levels observed with localized 1H-MRS in relation to changes in severity of hepatic encephalopathy (HE) in subjects with non-alcoholic liver cirrhosis. This study is a double-blind, placebo-controlled, randomized, cross-over design.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Flumazenil

Criteria

Inclusion Criteria:

1. Age: 18 and older

2. ICD-9 diagnosis of hepatic encephalopathy

3. Ability to feel comfortable in confined areas (like MRI)

4. Ability to provide informed consent

5. Speaks fluent English without any communication barriers

6. Reliable family member or friend able to stay with participant during abstinence from HE medication prior to visit.

Exclusion Criteria:

1. Current DSM-IV-R diagnosis of Alcohol or Other Drug Abuse or Dependence

2. Positive screen for alcohol abuse as determined by the CAGE questionnaire

3. Positive urine toxicity screen for benzodiazepine medications or illicit drugs

4. History of long-term use of benzodiazepine medications

5. Current use of non-benzodiazepine agonist medications

6. History of Panic Disorder

7. History of any Psychotic Disorder

8. History of seizures and/or Seizure Disorder

9. History of dysrhythmia, cardiovascular collapse, or recent head trauma

10. History of side effects from anticholinergic medications

11. History of cyclic antidepressant overdose or poisoning

12. Pregnant or nursing

13. Resides in nursing home or other long-term care facility