Neurobehavioral Mechanisms of Cocaine Choice
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Cocaine dose is administered under double-blind conditions. Available money value is not masked.
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
$0.25 alternative reinforcer value
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session.
Intervention: Money (Behavioral)
$0.25 alternative reinforcer value
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session.
Intervention: Cocaine HCl (Drug)
$1.00 alternative reinforcer value
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session.
Intervention: Money (Behavioral)
$1.00 alternative reinforcer value
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session.
Intervention: Cocaine HCl (Drug)
$4.00 alternative reinforcer value
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session.
Intervention: Money (Behavioral)
$4.00 alternative reinforcer value
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session.
Intervention: Cocaine HCl (Drug)
Outcomes
Primary Outcomes
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Joshua A. Lile, Ph.D.
Professor of Behavioral Science
University of Kentucky