Trial Outcomes & Findings for Effects of Tolcapone on Decision Making and Alcohol Intake in Alcohol Users (NCT NCT02740582)
NCT ID: NCT02740582
Last Updated: 2020-09-21
Results Overview
Number of drinks consumed in a laboratory bar session (out of a maximum of 4 drinks available) following either placebo or tolcapone administration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
A laboratory bar session is 1 hour long
Results posted on
2020-09-21
Participant Flow
Participant milestones
| Measure |
Tolcapone First
Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID
|
Placebo First
Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID
|
|---|---|---|
|
First Intervention
STARTED
|
29
|
33
|
|
First Intervention
COMPLETED
|
24
|
31
|
|
First Intervention
NOT COMPLETED
|
5
|
2
|
|
Washout
STARTED
|
24
|
31
|
|
Washout
COMPLETED
|
24
|
31
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
24
|
31
|
|
Second Intervention
COMPLETED
|
23
|
28
|
|
Second Intervention
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Tolcapone on Decision Making and Alcohol Intake in Alcohol Users
Baseline characteristics by cohort
| Measure |
Tolcapone First
n=23 Participants
Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID
Tolcapone
Placebo
|
Placebo First
n=28 Participants
Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID
Tolcapone
Placebo
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.4 years
n=5 Participants
|
27.3 years
n=7 Participants
|
25.98 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
28 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Self-reported alcoholic drinks / week
|
24.79 alcoholic drinks / week
n=5 Participants
|
18.13 alcoholic drinks / week
n=7 Participants
|
21.13 alcoholic drinks / week
n=5 Participants
|
PRIMARY outcome
Timeframe: A laboratory bar session is 1 hour longPopulation: Completers were analyzed
Number of drinks consumed in a laboratory bar session (out of a maximum of 4 drinks available) following either placebo or tolcapone administration.
Outcome measures
| Measure |
Tolcapone First, Then Placebo
n=23 Participants
Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID
Tolcapone
Placebo
|
Placebo First, Then Tolcapone
n=28 Participants
Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID
Tolcapone
Placebo
|
|---|---|---|
|
Number of Drinks Consumed in a Laboratory Bar Session
Drinks on Placebo
|
2.69 drinks
Standard Deviation 1.45
|
2.96 drinks
Standard Deviation 1.1
|
|
Number of Drinks Consumed in a Laboratory Bar Session
Drinks on tolcapone
|
2.73 drinks
Standard Deviation 1.38
|
2.39 drinks
Standard Deviation 1.66
|
Adverse Events
Tolcapone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebeo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Mitchell, PhD
University of California, San Franciso
Phone: 510-985-3522
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place