Trial Outcomes & Findings for Neurobehavioral Mechanisms of Cocaine Choice (NCT NCT04296006)
NCT ID: NCT04296006
Last Updated: 2025-04-03
Results Overview
The reinforcing effects of cocaine are determined using a reinforcement learning choice task. Subjects complete trials in which they could possibly receive the available cocaine dose or money. Reinforcing effects are measured for a fixed cocaine dose when three amounts of money are available as alternatives to cocaine. Each money value is tested in a separate session.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Choices occur across a 40 minute session
Results posted on
2025-04-03
Participant Flow
3 subjects were lost to follow up and 4 subjects were screen fails. All 8 subjects who were admitted to the inpatient unit completed the three within-subjects experimental conditions.
Participant milestones
| Measure |
The Impact of Alternative Reinforcer Magnitude on Cocaine vs Money Choice
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and varying amounts of money ($0.25, 1.00, 4.00) are available during each trial.
Money: Three money values offered as alternatives to cocaine.
Cocaine HCl: 3 mg/70 kg is available as an alternative to money.
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|---|---|
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Overall Study
STARTED
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8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurobehavioral Mechanisms of Cocaine Choice
Baseline characteristics by cohort
| Measure |
The Effects of Alternative Reinforcer Magnitude on Cocaine vs Money Choice
n=8 Participants
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and varying amounts of money ($0.25, 1.00, 4.00) are available during each trial.
Money: Three money values offered as alternatives to cocaine.
Cocaine HCl: 3 mg/70 kg is available as an alternative to money.
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|---|---|
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Age, Continuous
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49 years
n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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8 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Choices occur across a 40 minute sessionPopulation: People with cocaine use disorder
The reinforcing effects of cocaine are determined using a reinforcement learning choice task. Subjects complete trials in which they could possibly receive the available cocaine dose or money. Reinforcing effects are measured for a fixed cocaine dose when three amounts of money are available as alternatives to cocaine. Each money value is tested in a separate session.
Outcome measures
| Measure |
$0.25 Alternative Reinforcer Value
n=8 Participants
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $0.25 are available during each trial.
Money: Three money values offered as alternatives to cocaine.
Cocaine HCl: 3 mg/70 kg is available as an alternative to money.
|
$1.00 Alternative Reinforcer Value
n=8 Participants
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $1.00 are available during each trial.
Money: Three money values offered as alternatives to cocaine.
Cocaine HCl: 3 mg/70 kg is available as an alternative to money.
|
$4.00 Alternative Reinforcer Value
n=8 Participants
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $4.00 are available during each trial.
Money: Three money values offered as alternatives to cocaine.
Cocaine HCl: 3 mg/70 kg is available as an alternative to money.
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|---|---|---|---|
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The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
|
110 number of choices
Standard Deviation 34
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98 number of choices
Standard Deviation 17
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90 number of choices
Standard Deviation 12
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Adverse Events
$0.25 Alternative Reinforcer Value
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
$1.00 Alternative Reinforcer Value
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
$4.00 Alternative Reinforcer Value
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
$0.25 Alternative Reinforcer Value
n=8 participants at risk
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $0.25 are available during each trial.
Money: Three money values offered as alternatives to cocaine.
Cocaine HCl: 3 mg/70 kg is available as an alternative to money.
This is a within-subjects study, but AE results are reported by each of the three experimental conditions (i.e., 3 separate alternative money conditions) that each subject completed on separate sessions.
|
$1.00 Alternative Reinforcer Value
n=8 participants at risk
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $1.00 are available during each trial.
Money: Three money values offered as alternatives to cocaine.
Cocaine HCl: 3 mg/70 kg is available as an alternative to money.
This is a within-subjects study, but AE results are reported by each of the three experimental conditions (i.e., 3 separate alternative money conditions) that each subject completed on separate sessions.
|
$4.00 Alternative Reinforcer Value
n=8 participants at risk
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $4.00 are available during each trial.
Money: Three money values offered as alternatives to cocaine.
Cocaine HCl: 3 mg/70 kg is available as an alternative to money.
This is a within-subjects study, but AE results are reported by each of the three experimental conditions (i.e., 3 separate alternative money conditions) that each subject completed on separate sessions.
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|---|---|---|---|
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Cardiac disorders
Elevated Heart Rate
|
12.5%
1/8 • Number of events 1 • AEs were collected during the duration of data collection on three separate days.
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0.00%
0/8 • AEs were collected during the duration of data collection on three separate days.
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0.00%
0/8 • AEs were collected during the duration of data collection on three separate days.
|
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Cardiac disorders
Elevated Blood Pressure
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12.5%
1/8 • Number of events 1 • AEs were collected during the duration of data collection on three separate days.
|
0.00%
0/8 • AEs were collected during the duration of data collection on three separate days.
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0.00%
0/8 • AEs were collected during the duration of data collection on three separate days.
|
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Nervous system disorders
Headache
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12.5%
1/8 • Number of events 1 • AEs were collected during the duration of data collection on three separate days.
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12.5%
1/8 • Number of events 1 • AEs were collected during the duration of data collection on three separate days.
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12.5%
1/8 • Number of events 1 • AEs were collected during the duration of data collection on three separate days.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place