Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

women with a negative pregnancy test and not nursing, must be regularly using birth control
are non-treatment seeking.
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
are non-treatment seeking.
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;
negative breath alcohol at screening and on each test day;
between the ages of 21 and 55 years;
males and females
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
not taking any psychoactive medication or opioids (in past 30-days);

Exclusion Criteria

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;
unwillingness to remain alcohol-free 12 hours prior to test days;
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)
...
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;
unwillingness to remain alcohol-free 12 hours prior to test days;
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)
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
they need detoxification determined by a CIWA score of >8 or have had a history of alcohol detoxification in the past;

Summary

Conditions
Alcoholism
Type
Interventional
Phase
Phase 1Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 70 years
Gender
Both males and females

Description

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=...

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), and twenty-five social drinkers (N=25) 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

women with a negative pregnancy test and not nursing, must be regularly using birth control
are non-treatment seeking.
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
are non-treatment seeking.
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;
negative breath alcohol at screening and on each test day;
between the ages of 21 and 55 years;
males and females
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
not taking any psychoactive medication or opioids (in past 30-days);

Exclusion Criteria

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;
unwillingness to remain alcohol-free 12 hours prior to test days;
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)
...
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;
unwillingness to remain alcohol-free 12 hours prior to test days;
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)
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
they need detoxification determined by a CIWA score of >8 or have had a history of alcohol detoxification in the past;

Tracking Information

NCT #
NCT02120365
Collaborators
  • University of Connecticut
  • Yale University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
  • Principal Investigator: Albert Arias, MD Virginia CommonwealthUniversity
  • Albert Arias, MD Virginia CommonwealthUniversity
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