Print

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.