Neurobehavioral Mechanisms of Cocaine Choice

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 Overview

• Status: Completed
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Behavioral: Money; Drug: Cocaine HCl

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0086
      • Laboratory of Human Behavioral Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: $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.	Behavioral: Money; Three money values offered as alternatives to cocaine.; Drug: Cocaine HCl; 3 mg/70 kg is available as an alternative to money.
Experimental: $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.	Behavioral: Money; Three money values offered as alternatives to cocaine.; Drug: Cocaine HCl; 3 mg/70 kg is available as an alternative to money.
Experimental: $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.	Behavioral: Money; Three money values offered as alternatives to cocaine.; Drug: Cocaine HCl; 3 mg/70 kg is available as an alternative to money.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Choices occur across a 40 minute session

Collaborators and Investigators

• Sponsor: Joshua A. Lile, Ph.D.
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Joshua Lile, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Vasoconstrictor Agents; Cocaine
• Other Study ID Numbers: BED(In)(41); R01DA045023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No