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Clinical Trials/NCT04296006
NCT04296006
Completed
Early Phase 1

Neurobehavioral Mechanisms of Cocaine Choice

Joshua A. Lile, Ph.D.1 site in 1 country15 target enrollmentJanuary 15, 2021

Overview

Phase
Early Phase 1
Intervention
Money
Conditions
Cocaine Use Disorder
Sponsor
Joshua A. Lile, Ph.D.
Enrollment
15
Locations
1
Primary Endpoint
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2021
End Date
February 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Joshua A. Lile, Ph.D.
Responsible Party
Sponsor Investigator
Principal Investigator

Joshua A. Lile, Ph.D.

Professor of Behavioral Science

University of Kentucky

Eligibility Criteria

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

$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

$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

$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

$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

$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

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.

Study Sites (1)

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