Cocaine Use Disorder
Conditions
Brief summary
The objective of this protocol is to use a drug-vs-money choice task, reinforcement learning modeling and fMRI to determine the neurobehavioral and neurobiological decision-making profile associated with the decision to take cocaine and the reduced cocaine choice that occurs during a behavioral intervention (alternative money reinforcer) that models contingency management.
Interventions
BEHAVIORALMoney
Three money values offered as alternatives to cocaine.
DRUGCocaine HCl
3 mg/70 kg is available as an alternative to money.
Sponsors
National Institute on Drug Abuse (NIDA)
Joshua A. Lile, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Cocaine dose is administered under double-blind conditions. Available money value is not masked.
Intervention model description
A placebo-controlled, randomized, within-subjects design will be used to assess cocaine-vs-money choice in cocaine use disordered subjects as a function of alternative reinforcer value.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Recent cocaine use, otherwise healthy
Exclusion criteria
* Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Choices occur across a 40 minute session | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| The Effects 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | The Effects of Alternative Reinforcer Magnitude on Cocaine vs Money Choice |
|---|---|
| Age, Continuous | 49 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 3 / 8 | 1 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
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.
Time frame: Choices occur across a 40 minute session
Population: People with cocaine use disorder
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| $0.25 Alternative Reinforcer Value | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 110 number of choices | Standard Deviation 34 |
| $1.00 Alternative Reinforcer Value | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 98 number of choices | Standard Deviation 17 |
| $4.00 Alternative Reinforcer Value | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 90 number of choices | Standard Deviation 12 |