Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder

  • STATUS
    Recruiting
  • End date
    Oct 17, 2022
  • participants needed
    20
  • sponsor
    Virginia Commonwealth University
Updated on 17 June 2021
hysterectomy
heavy drinking
lfts
experimental drug
alcohol use disorder
disulfiram

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 by the U.S. Food and Drug Administration (FDA) for the treatment of seizures but has not yet been approved to treat alcohol use disorders. For this reason, it is considered an investigational drug. Some people in this study will receive Perampanel alone and some people will receive Perampanel and Disulfiram, this will be determined by the pharmacy.

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 questions about their medical history, drinking behavior and life events, have bloodwork checked routinely, have regular medication counseling, and perform some computer tasks. Throughout the study, there will be regular phone calls from staff. Participants will also be asked to use a device called "Soberlink" which is like an at-home breathalyzer test to help track progress throughout the study.

Participants will be randomly assigned (like the flip of a coin) to receive either Perampanel alone or Peramanel and Disulfiram.

Participation in this study will last up to 10 weeks. Approximately 20 individuals will participate in this study.

This study will sequence all or part of participant's DNA. This is a necessary part of the study.

Before starting the study, participants may be referred to an alcohol detoxification program (medical treatment of an alcoholic), if clinically indicated.

Details
Condition Alcohol Disorders
Treatment Disulfiram, Perampanel Tablet
Clinical Study IdentifierNCT04502589
SponsorVirginia Commonwealth University
Last Modified on17 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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