Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

not taking any psychoactive medication or opioids (in past 30-days);
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);
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;
males and females
between the ages of 21 and 55 years;
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;
are non-treatment seeking.
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

Exclusion Criteria

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

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

not taking any psychoactive medication or opioids (in past 30-days);
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);
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;
males and females
between the ages of 21 and 55 years;
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;
are non-treatment seeking.
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

Exclusion Criteria

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

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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