Neurobehavioral Mechanisms of Cocaine Choice

NCT04296006 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: BED(In)(41)R01DA045023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

$0.25 alternative reinforcer value

EXPERIMENTAL

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; Drug: Cocaine HCl

$1.00 alternative reinforcer value

EXPERIMENTAL

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; Drug: Cocaine HCl

$4.00 alternative reinforcer value

EXPERIMENTAL

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; Drug: Cocaine HCl

Interventions

Money BEHAVIORAL

Three money values offered as alternatives to cocaine.

$0.25 alternative reinforcer value; $1.00 alternative reinforcer value; $4.00 alternative reinforcer value

Cocaine HCl DRUG

3 mg/70 kg is available as an alternative to money.

$0.25 alternative reinforcer value; $1.00 alternative reinforcer value; $4.00 alternative reinforcer value

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Recent cocaine use, otherwise healthy

You may not qualify if:

• Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease

Sponsors & Collaborators

• Joshua A. Lile, Ph.D.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, 40536-0086, United States

Location

MeSH Terms

Interventions

Cocaine

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Joshua Lile, Ph.D.
• Organization: University of Kentucky

jalile2@uky.edu

859-323-6034

Study Officials

• Joshua Lile, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Cocaine dose is administered under double-blind conditions. Available money value is not masked.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Behavioral Science

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: January 15, 2021
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)