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NCT04296006 Clinical Trial

Neurobehavioral Mechanisms of Cocaine Choice

Cocaine Use Disorder Clinical Trial

Official title:
Neurobehavioral Mechanisms of Cocaine Choice

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04296006
Other study ID # BED(In)(41)
Secondary ID R01DA045023
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 15, 2021
Est. completion date February 15, 2025

Study information
Verified date May 2024
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 behavioral and pharmacological interventions.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date February 15, 2025
Est. primary completion date February 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sustained Release d-amphetamine
Twice daily administration of active or placebo d-amphetamine
Behavioral:
• Money
Three money values offered as alternatives to cocaine

Locations
Country Name City State
United States Laboratory of Human Behavioral Pharmacology Lexington Kentucky

Sponsors (2)
Lead Sponsor Collaborator
Joshua A. Lile, Ph.D. National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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