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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

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.

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.