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
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 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
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