Neurobehavioral Mechanisms of Cocaine Choice

January 10, 2024 updated by: Joshua A. Lile, Ph.D.
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 behavioral and pharmacological interventions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0086
        • Recruiting
        • Laboratory of Human Behavioral Pharmacology
        • Contact:
        • Principal Investigator:
          • Joshua A. Lile, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Treatment
Cocaine choice during d-amphetamine maintenance
Drug: Sustained Release d-amphetamine
Twice daily administration of active or placebo d-amphetamine
Other Names:
  • Dexedrine Spansule SR
Behavioral: Money
Three money values offered as alternatives to cocaine
Placebo Comparator: Placebo Treatment
Cocaine choice during placebo maintenance
Drug: Sustained Release d-amphetamine
Twice daily administration of active or placebo d-amphetamine
Other Names:
  • Dexedrine Spansule SR
Behavioral: Money
Three money values offered as alternatives to cocaine

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
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 during both d-amphetamine and placebo maintenance and when three amounts of money are available as alternatives to cocaine.
Choices occur across a 40 minute session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

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)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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