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Neurobehavioral Mechanisms of Cocaine Choice

Sponsor
Joshua A. Lile, Ph.D. (Other)
Overall Status
Recruiting
CT.gov ID
NCT04296006
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
39.5
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sustained Release d-amphetamine
  • Behavioral: Money
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
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.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.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
d-Amphetamine doses will be administered under double-blind conditions.
Primary Purpose:
Basic Science
Official Title:
Neurobehavioral Mechanisms of Cocaine Choice
Actual Study Start Date :
Jan 15, 2021
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative [Choices occur across a 40 minute session]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Laboratory of Human Behavioral Pharmacology Lexington Kentucky United States 40536-0086

    Sponsors and Collaborators

    • Joshua A. Lile, Ph.D.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joshua A. Lile, Ph.D., Professor of Behavioral Science, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT04296006
    Other Study ID Numbers:
    • BED(In)(41)
    First Posted:
    Mar 5, 2020
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Amphetamine
    Dextroamphetamine

    Study Results

    No Results Posted as of Mar 15, 2022