The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
University of California Los Angeles
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
Brown University
Providence, Rhode Island, United States
Alcohol Craving
Strength of alcohol craving Visual Analogue Scale (VAS) score; min=0, max=20; higher scores = more craving (worse outcome)
Time frame: Week 3
Number of Subjects With no Heavy Drinking Days
Number of subjects that have no heavy drinking days during weeks 3 to 6 of the treatment phase. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Time frame: Weeks 3 to 6 of the treatment phase
Number of Subjects Abstinent From Alcohol
Number of subjects that have not drank alcohol during Weeks 3 to 6 of the treatment phase.
Time frame: Weeks 3 to 6 of the treatment phase
WHO 1-level Decrease in Alcohol Consumption
The number of subjects experiencing at least a 1-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during Weeks 3 to 6 of the treatment phase. The WHO levels of average alcohol consumption per day are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.
Time frame: Weeks 3 to 6 of the treatment phase
WHO 2-level Decrease in Alcohol Consumption
The number of subjects experiencing at least a 2-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during Weeks 3 to 6 of the treatment phase. The WHO levels of average alcohol consumption per day are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.
Time frame: Weeks 3 to 6 of the treatment phase.
Percentage of Days Abstinent
The percentage of days abstinent from drinking alcohol
Time frame: Weeks 3 to 6 of the treatment phase
Percentage of Heavy Drinking Days
Percentage of heavy drinking days where a heavy drinking day is 4 or more drinks on a day for women or 5 or more drinks on a day for men.
Time frame: Weeks 3 to 6 of the treatment phase
Drinks Per Week
The number of drinks consumed per week
Time frame: Weeks 3 to 6 of the treatment phase
Drinks Per Drinking Day
The number of drinks consumed on days where participants drank
Time frame: Weeks 3 to 6 of the treatment phase
Penn Alcohol Craving Scale (PACS)
The amount of craving; higher numbers indicate more craving. There are 5 items each on a 0 to 6 scale. Items are summed to get to the total craving, resulting in scores having a min=0 and max=30.
Time frame: Weeks 3 to 6 during the treatment phase, averaged
Pittsburgh Sleep Quality Index (PSQI)
A measure of sleep quality; the PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Time frame: Weeks 4 & 6 of the treatment phase, averaged
Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Related Negative Consequences
A measure of alcohol-related negative consequences. There are 7 items scored on a 1 to 7 scale (a higher score indicative greater frequency of negative consequences). The items are summed and converted to a T-score to create a total score. The T-scores range from 0 to 100 (the population mean = 50 and standard deviation = 10). Higher T-scores are indicative of more negative consequences (worse outcome).
Time frame: Week 6 of the treatment phase
Profile of Mood States (POMS) Total Disturbance
A measure of total mood disturbance. Total mood disturbance is the sum of depression, anger, fatigue, confusion, and tension subscales subtracting the vigor subscale items. The range of possible scores is from -32 to 200 with higher scores indicating greater mood disturbance.
Time frame: Weeks 4 & 6 of the treatment phase, averaged
Cigarettes Smoked Per Day (Among Smokers)
The number of cigarettes smoked per day, computed among individuals who smoked at baseline
Time frame: Weeks 3 to 6 of the treatment phase
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