Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence

NCT02120365 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-08-18

Study results available
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Summary

The purpose of this study is to determine whether perampanel alters the response to alcohol for heavy drinkers. It is hypothesized that perampanel will reduce the rewarding and reinforcing properties of alcohol in the laboratory setting.

Conditions

  • Alcoholism

Interventions

DRUG

Perampanel

Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.

DRUG

Placebo

Placebo given in place of perampanel during the pre-treatment period and lab session days.

Sponsors & Collaborators

  • University of Connecticut

    collaborator OTHER
  • Yale University

    collaborator OTHER
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Albert Arias, MD · Virginia CommonwealthUniversity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2022-02-15
Completion
2022-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120365 on ClinicalTrials.gov