Trial Outcomes & Findings for Dopamine Responsivity in Gamblers (NCT NCT02772978)
NCT ID: NCT02772978
Last Updated: 2021-02-16
Results Overview
The presented value represents a correlation. Subjects completed a delay discounting task while functional MRI images were obtained. In this task, subjects made hypothetical choices between a smaller amount of money available sooner, and a larger amount of money available later. Performance on the delay discounting task, as assessed by the impulsive choice ratio, was determined for both the tolcapone and placebo sessions, and the difference between them (tolcapone minus placebo) was calculated. This difference value was then correlated with scores on the Barratt Impulsiveness Scale, non-planning subscale.
COMPLETED
NA
19 participants
120 minutes after drug ingestion
2021-02-16
Participant Flow
Patients were recruited from the community between June 2014 and September 2015.
Participant milestones
| Measure |
Functional MRI Arm - Tolcapone, Then Placebo
This cognitive science study consists of a single "arm" in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion
Tolcapone: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors
Placebo: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients
|
Functional MRI Arm - Placebo, Then Tolcapone
This cognitive science study consists of a single "arm" in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion
Tolcapone: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors
Placebo: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Functional MRI Arm - Tolcapone, Then Placebo
This cognitive science study consists of a single "arm" in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion
Tolcapone: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors
Placebo: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients
|
Functional MRI Arm - Placebo, Then Tolcapone
This cognitive science study consists of a single "arm" in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion
Tolcapone: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors
Placebo: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Dopamine Responsivity in Gamblers
Baseline characteristics by cohort
| Measure |
Functional MRI Arm
n=17 Participants
This cognitive science study consists of a single "arm" in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion
Tolcapone: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors
Placebo: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients
|
|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
6 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
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=99 Participants
|
|
Barratt Impulsiveness Scale, Non-planning Subscale
|
25.6 units on a scale
STANDARD_DEVIATION 4.7 • n=99 Participants
|
PRIMARY outcome
Timeframe: 120 minutes after drug ingestionPopulation: The outcome for this study was the correlation between the BIS score, non-planning subscale, and the difference in ICR (tolcapone minus placebo). As such, one Arm/Group is presented below.
The presented value represents a correlation. Subjects completed a delay discounting task while functional MRI images were obtained. In this task, subjects made hypothetical choices between a smaller amount of money available sooner, and a larger amount of money available later. Performance on the delay discounting task, as assessed by the impulsive choice ratio, was determined for both the tolcapone and placebo sessions, and the difference between them (tolcapone minus placebo) was calculated. This difference value was then correlated with scores on the Barratt Impulsiveness Scale, non-planning subscale.
Outcome measures
| Measure |
Functional MRI Arm (Tolcapone and Placebo)
n=17 Participants
This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion. Tolcapone is a medication in the class of catechol-O-methyltransferase (COMT) inhibitors. A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients.
|
|---|---|
|
Correlation Between the Impulsive Choice Ratio and Baseline Impulsivity, as Measured With the Barratt Impulsiveness Scale, Non-planning Subscale
|
-0.5 Correlation coefficient
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 minutes after drug ingestionPopulation: The outcome for this study was the correlation between the difference in the ICR and the difference in BOLD activity (tolcapone minus placebo). As such, one Arm / Group is presented below.
The presented value represents a correlation. The difference in performance on the delay discounting task was calculated as the change in ICR (tolcapone minus placebo). In addition, the difference in BOLD activity throughout the brain was determined (tolcapone minus placebo).
Outcome measures
| Measure |
Functional MRI Arm (Tolcapone and Placebo)
n=17 Participants
This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion. Tolcapone is a medication in the class of catechol-O-methyltransferase (COMT) inhibitors. A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients.
|
|---|---|
|
Correlation Between the Difference in ICR (Tolcapone Minus Placebo) and the Difference in Blood Oxygen Level Dependent (BOLD) Signal in the Brain (Tolcapone Minus Placebo)
|
-0.76 Correlation coefficient
|
Adverse Events
Tolcapone Arm
Placebo Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrew Kayser, MD PhD
University of California at San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place