NCT04502589

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Alcohol Disorders

Interventions

Type	Name	Description
DRUG	Perampanel Tablet	Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups
DRUG	Disulfiram	Disulfiram will be kept at 250mg daily

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-08-11
• Completion: 2021-08-11
• First posted: 2020-08-06
• Last updated: 2022-10-07
• Results posted: 2022-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study