Status:
COMPLETED
Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Disorders
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug Perampanel when used in persons who drink and wish to stop drinking. Perampanel has been approved ...
Detailed Description
Participants will be asked to take a medication (Perampanel or Perampanel + Disulfiram) every day for approximately 8 weeks and have weekly study visits. At these visits, participants will be asked qu...
Eligibility Criteria
Inclusion
- Men and women ages 21-70 with DSM-5 AUD;
- regular heavy drinkers as defined by averaging ≥ 2 heavy drinking days per week over the 60 days baseline pre-treatment TLFB, and recognize a need to completely stop drinking;
- willingness to provide written, informed consent to participate in the study;
- Individuals with LFTs that are no more than 2-3 times above the normal levels and with a Child-Pugh score of no greater than 5 will be included and
- women of child-bearing potential (i.e., no hysterectomy, bilateral oophorectomy, or tubal ligation or \<2 years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment.
Exclusion
- a current, clinically significant physical disease \[i.e., neurologic, renal, pulmonary, cardiovascular, hepatic\] on the basis of medical history, physical examination, or routine laboratory evaluation that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities related to hepatic function such as marked elevations of hepatic aminotransferase levels (i.e., AST and ALT) or direct bilirubin;
- history of renal compromise or current renal disease (as evidenced by serum creatinine above our laboratory's reference limit of 1.7 mg/dL;
- history of seizure disorder;
- use of any of a number of medications that might prominently influence drinking patterns or cause risk of harm or injury (e.g., other anticonvulsants, medications to treat AUD, opioid pain medication), currently taking CNS depressants (e.g. benzodiazepines, barbiturates, sedating antihistamines;
- schizophrenia, bipolar disorder, current major depressive episode, or substantial suicide or violence risk on the basis of history or psychiatric examination;
- currently dependent on stimulants, opioids or sedatives;
- subjects with any substantial alcohol withdrawal will be required to be detoxified by regular clinical services prior to study entry;
- are currently taking any medication that is a moderate to strong CYP3A4 inhibitor or inducer if participants are required to initiate these medications by an outside provider during the course of this study, they will be tapered off the study regimen and we will have them terminate early)
- are taking phenytoin or warfarin
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04502589
Start Date
October 15 2020
End Date
August 11 2021
Last Update
October 7 2022
Active Locations (1)
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1
Virginia Commonwealth University Inst. for Drug and Alcohol Studies
Richmond, Virginia, United States, 23219