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 a behavioral intervention (alternative money reinforcer) that models contingency management.

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
Single Group Assignment
Intervention Model Description
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.
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)
Masking Description
Cocaine dose is administered under double-blind conditions. Available money value is not masked.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
$0.25 alternative reinforcer value 		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
    Three money values offered as alternatives to cocaine.
  • Drug: Cocaine HCl
    3 mg/70 kg is available as an alternative to money.
Experimental
$1.00 alternative reinforcer value 		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
    Three money values offered as alternatives to cocaine.
  • Drug: Cocaine HCl
    3 mg/70 kg is available as an alternative to money.
Experimental
$4.00 alternative reinforcer value 		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
    Three money values offered as alternatives to cocaine.
  • Drug: Cocaine HCl
    3 mg/70 kg is available as an alternative to money.

Recruiting Locations

More Details

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