Trial Outcomes & Findings for Human Laboratory Study of ASP8062 for Alcohol Use Disorder (NCT NCT05096117)
NCT ID: NCT05096117
Last Updated: 2024-12-03
Results Overview
Strength of alcohol craving Visual Analogue Scale (VAS) score; min=0, max=20; higher scores = more craving (worse outcome)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Week 3
Results posted on
2024-12-03
Participant Flow
Participant milestones
| Measure |
ASP8062 (25 mg Once Daily)
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human Laboratory Study of ASP8062 for Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
26 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Drinks per week
|
53.5 Standard drinks of alcohol/week
STANDARD_DEVIATION 22.1 • n=5 Participants
|
52.3 Standard drinks of alcohol/week
STANDARD_DEVIATION 20.1 • n=7 Participants
|
52.9 Standard drinks of alcohol/week
STANDARD_DEVIATION 21.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 3Strength of alcohol craving Visual Analogue Scale (VAS) score; min=0, max=20; higher scores = more craving (worse outcome)
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Alcohol Craving
|
6.44 score on a scale
Standard Error 1.09
|
6.26 score on a scale
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 of the treatment phaseNumber 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.
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Number of Subjects With no Heavy Drinking Days
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 of the treatment phaseNumber of subjects that have not drank alcohol during Weeks 3 to 6 of the treatment phase.
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Number of Subjects Abstinent From Alcohol
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 of the treatment phaseThe 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.
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
WHO 1-level Decrease in Alcohol Consumption
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 of the treatment phase.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.
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
WHO 2-level Decrease in Alcohol Consumption
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 of the treatment phaseThe percentage of days abstinent from drinking alcohol
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Percentage of Days Abstinent
|
29.9 percentage of days abstinent
Standard Error 5.4
|
39.3 percentage of days abstinent
Standard Error 5.6
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 of the treatment phasePercentage 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.
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
42.4 percentage of heavy drinking days
Standard Error 6.1
|
35.9 percentage of heavy drinking days
Standard Error 6.3
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 of the treatment phaseThe number of drinks consumed per week
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Drinks Per Week
|
28.2 standard drinks of alcohol/week
Standard Error 4.0
|
23.7 standard drinks of alcohol/week
Standard Error 4.1
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 of the treatment phaseThe number of drinks consumed on days where participants drank
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Drinks Per Drinking Day
|
5.7 standard drinks of alcohol/drinking day
Standard Error 0.5
|
5.5 standard drinks of alcohol/drinking day
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 during the treatment phase, averagedThe 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.
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Penn Alcohol Craving Scale (PACS)
|
13.5 score on a scale
Standard Error 0.9
|
13.0 score on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Weeks 4 & 6 of the treatment phase, averagedA 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.
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
|
5.7 score on a scale
Standard Error 0.4
|
6.1 score on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Week 6 of the treatment phaseA 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).
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Related Negative Consequences
|
50.2 T-score
Standard Error 1.0
|
47.8 T-score
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Weeks 4 & 6 of the treatment phase, averagedA 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.
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Profile of Mood States (POMS) Total Disturbance
|
5.0 score on a scale
Standard Error 3.6
|
0.5 score on a scale
Standard Error 3.8
|
SECONDARY outcome
Timeframe: Weeks 3 to 6 of the treatment phaseThe number of cigarettes smoked per day, computed among individuals who smoked at baseline
Outcome measures
| Measure |
ASP8062 (25 mg Once Daily)
n=28 Participants
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=26 Participants
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Cigarettes Smoked Per Day (Among Smokers)
|
10.3 cigarettes smoked per day
Standard Error 1.2
|
10.7 cigarettes smoked per day
Standard Error 2.0
|
Adverse Events
ASP8062 (25 mg Once Daily)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ASP8062 (25 mg Once Daily)
n=30 participants at risk
ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
|
Matching Placebo
n=30 participants at risk
Placebo: 1 x per day for 6 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Eye disorders
Blepharitis
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Eye disorders
Photophobia
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
13.3%
4/30 • Number of events 4 • 6 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30 • Number of events 4 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Gastrointestinal disorders
Toothache
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Number of events 5 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
General disorders
Fatigue
|
10.0%
3/30 • Number of events 3 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
General disorders
Influenza like illness
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Infections and infestations
Bronchitis
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Ear infection
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Infections and infestations
Hordeolum
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Infections and infestations
Influenza like illness
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
3/30 • Number of events 3 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Oral herpes
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
4/30 • Number of events 4 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Investigations
Blood albumin increased
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/30 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Investigations
Blood cholesterol increased
|
13.3%
4/30 • Number of events 4 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Investigations
Blood creatinine decreased
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Investigations
Blood urea increased
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Investigations
Blood urine present
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Investigations
Glucose urine present
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Investigations
Protein urine
|
13.3%
4/30 • Number of events 4 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Investigations
Red blood cell count decreased
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Investigations
Red cell distribution width increased
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Investigations
Triglyceride analyses
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Investigations
Urine ketone body present
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Investigations
Urine leukocyte esterase positive
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Investigations
White blood cell count increased
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/30 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Nervous system disorders
Amnesia
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Nervous system disorders
Dizziness
|
13.3%
4/30 • Number of events 5 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Number of events 5 • 6 weeks
|
13.3%
4/30 • Number of events 6 • 6 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
Somnolence
|
13.3%
4/30 • Number of events 4 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Psychiatric disorders
Abnormal dreams
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/30 • 6 weeks
|
10.0%
3/30 • Number of events 3 • 6 weeks
|
|
Psychiatric disorders
Blunted affect
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
6.7%
2/30 • Number of events 6 • 6 weeks
|
|
Psychiatric disorders
Irritability
|
3.3%
1/30 • Number of events 2 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Psychiatric disorders
Restlessness
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Psychiatric disorders
Stress
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
3.3%
1/30 • Number of events 2 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
6.7%
2/30 • Number of events 2 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Vascular disorders
Hot flush
|
3.3%
1/30 • Number of events 1 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
|
Vascular disorders
Hypertension
|
33.3%
10/30 • Number of events 17 • 6 weeks
|
23.3%
7/30 • Number of events 8 • 6 weeks
|
Additional Information
Dr. Daniel Falk
National Institute on Alcohol Abuse and Alcoholism
Phone: 3014430788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place