Trial Outcomes & Findings for Probenecid as Medication for Alcohol Use Disorder (PROB) (NCT NCT04218357)
NCT ID: NCT04218357
Last Updated: 2025-02-27
Results Overview
The stimulant effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES). The BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the stimulation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome). The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.
COMPLETED
PHASE1
35 participants
Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).
2025-02-27
Participant Flow
Participant milestones
| Measure |
Matching Placebo, Then Probenecid
Study Drug one pill by mouth once, for one day
Matching placebo: Placebo
|
Probenecid, Then Matching Placebo
2g probenecid, one pill by mouth once, for one day
Probenecid
|
|---|---|---|
|
1st Allocation
STARTED
|
18
|
17
|
|
1st Allocation
COMPLETED
|
17
|
17
|
|
1st Allocation
NOT COMPLETED
|
1
|
0
|
|
2nd Allocation (Cross Over)
STARTED
|
17
|
17
|
|
2nd Allocation (Cross Over)
COMPLETED
|
17
|
17
|
|
2nd Allocation (Cross Over)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Matching Placebo, Then Probenecid
Study Drug one pill by mouth once, for one day
Matching placebo: Placebo
|
Probenecid, Then Matching Placebo
2g probenecid, one pill by mouth once, for one day
Probenecid
|
|---|---|---|
|
1st Allocation
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Probenecid as Medication for Alcohol Use Disorder (PROB)
Baseline characteristics by cohort
| Measure |
Overall Sample
n=35 Participants
Placebo, then probenecid one pill by mouth once, for one day or Probenecid then placebo one pill by mouth once, for one day
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
|
Diagnosis of alcohol use disorder (AUD) by SCID-5
no AUD
|
9 Participants
n=99 Participants
|
|
Diagnosis of alcohol use disorder (AUD) by SCID-5
Mild AUD
|
12 Participants
n=99 Participants
|
|
Diagnosis of alcohol use disorder (AUD) by SCID-5
Moderate AUD
|
8 Participants
n=99 Participants
|
|
Diagnosis of alcohol use disorder (AUD) by SCID-5
Severe AUD
|
6 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).The stimulant effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES). The BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the stimulation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome). The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.
Outcome measures
| Measure |
Matching Placebo
n=35 Participants
Placebo, one pill by mouth once, for one day
Matching placebo: Placebo
|
Probenecid
n=34 Participants
2g probenecid, one pill by mouth once, for one day
Probenecid: safety
|
|---|---|---|
|
Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo
Ascending alcohol BrAC
|
28.23 scores on scale
Standard Deviation 21.82
|
25.26 scores on scale
Standard Deviation 20.66
|
|
Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo
Descending alcohol BrAC
|
20.57 scores on scale
Standard Deviation 18.95
|
19.56 scores on scale
Standard Deviation 20.33
|
SECONDARY outcome
Timeframe: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).The sedative effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES). The BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the sedation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome). The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.
Outcome measures
| Measure |
Matching Placebo
n=35 Participants
Placebo, one pill by mouth once, for one day
Matching placebo: Placebo
|
Probenecid
n=34 Participants
2g probenecid, one pill by mouth once, for one day
Probenecid: safety
|
|---|---|---|
|
Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo
Ascending limb of BrAC
|
16.02 scores on scale
Standard Deviation 14.21
|
16.79 scores on scale
Standard Deviation 15.17
|
|
Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo
Descending limb of BrAC
|
16.26 scores on scale
Standard Deviation 15.27
|
16.50 scores on scale
Standard Deviation 15.15
|
SECONDARY outcome
Timeframe: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).Alcohol craving is assessed using change in the alcohol urge questionnaire (AUQ). The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). Drinking refers to various types of alcohol, including beer, wine and liquor. The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Minimum score is 7, maximum score is 48. Higher scores reflect greater alcohol craving (worse outcome).
Outcome measures
| Measure |
Matching Placebo
n=35 Participants
Placebo, one pill by mouth once, for one day
Matching placebo: Placebo
|
Probenecid
n=34 Participants
2g probenecid, one pill by mouth once, for one day
Probenecid: safety
|
|---|---|---|
|
Alcohol Craving
Ascending limb of BrAC
|
23.09 score on scale
Standard Deviation 13.23
|
17.24 score on scale
Standard Deviation 10.47
|
|
Alcohol Craving
Descending limb of BrAC
|
19.63 score on scale
Standard Deviation 12.04
|
18.38 score on scale
Standard Deviation 12.29
|
Adverse Events
Matching Placebo
Probenecid
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place