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

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University; Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Connecticut; Yale University
• Treatments: Anticonvulsants; Ethanol

Criteria

Inclusion Criteria:

• males and females

• between the ages of 21 and 55 years;

• NTSHDs as defined above, and must have had at least 5 SD in one day on at least some occasions in the past and been able to tolerate it without an adverse reaction

• generally medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratory results (CBC w/ differential, TSH, Free-T4, AST, ALT, GGT, BUN, creatinine, electrolytes, urinalysis, beta-HCG). Individuals with LFTs that are no more than 3 times above the normal levels will be included;

• women with a negative pregnancy test and not nursing, must be regularly using birth control

• negative breath alcohol at screening and on each test day;

• not taking any psychoactive medication or opioids (in past 30-days);

• are non-treatment seeking.

Exclusion Criteria:

• they need detoxification determined by a CIWA score of >8 or have had a history of alcohol detoxification in the past;

• have been in treatment for an alcohol problem within the last 6 months, or if the severity of their alcohol problem based on the research physician's assessment warrants definitive treatment;

• meet criteria for DSM-IV psychiatric and substance use disorder diagnosis (other than alcohol abuse/dependence, cannabis abuse/dependence and nicotine dependence; those diagnoses will be allowed; participants can be either smokers up to 1 pack per day or non-smokers) based on history and psychiatric evaluation that includes a structured diagnostic interview (Structured Clinical Interview for DSM-IV Axis I Disorders: SCID)

• unwillingness to remain alcohol-free 12 hours prior to test days;

• have a significant ongoing serious medical condition such as Diabetes Mellitus, liver disease (see above LFT guideline), renal disease (as evidenced by serum creatinine above our laboratory's reference limit of 1.7 mg/dL, or have a history of adverse reaction to IV placement/blood draw