Neurobehavioral Mechanisms of Cocaine Choice

Purpose

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.

Condition

  • Cocaine Use Disorder

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
A placebo-controlled, randomized, within-subjects design will be used to assess drug-vs-money choice in cocaine use disordered subjects as a function of alternative reinforcer value and d-amphetamine SR treatment.
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)
Masking Description
d-Amphetamine doses will be administered under double-blind conditions.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky 40536-0086
Contact:
Frances Wagner, RN
859-257-5388
fpwagn2@uky.edu

More Details

NCT ID
NCT04296006
Status
Recruiting
Sponsor
Joshua A. Lile, Ph.D.