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



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 55
Updated:4/21/2016
Start Date:March 2016
End Date:April 2018
Contact:Albert Arias, MD
Email:albert.arias@yale.edu
Phone:203-932-5711

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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.

The main goal of the proposed study is to determine whether the AMPA-R antagonist perampanel
alters the response to ethanol (i.e., the rewarding and reinforcing effects) using a
validated laboratory paradigm of intravenous (IV) ethanol infusion. Fifty non-treatment
seeking heavy drinkers (NTSHDs, N=50), will undergo three test days each: once after
receiving a placebo medication, once after receiving moderate dose perampanel, and once
after receiving a higher dose of perampanel. This experiment is the first step in a series
of expedient studies that will rapidly determine perampanel's potential as a treatment for
alcohol dependence. If findings show perampanel reduces the rewarding and reinforcing
properties of alcohol in the laboratory setting (in humans), it would provide a strong
rationale for clinical treatment trials with this medication. This approach is innovative
because it tests a highly novel AMPA-R antagonist for the treatment of alcoholism, and uses
a state-of-the-art computer assisted IV alcohol pump infusion system (called CAIS) to reduce
variability in blood alcohol concentrations, thus improving the data quality.

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, 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
We found this trial at
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New Haven, Connecticut 06510
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West Haven, Connecticut 06515
Phone: 203-932-5711
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