Neurobehavioral Mechanisms of Cocaine Choice

NCT ID: NCT04296006

Last Updated: 2025-04-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Cocaine dose is administered under double-blind conditions. Available money value is not masked.

Study Groups

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$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.

Group Type EXPERIMENTAL

Money

Intervention Type BEHAVIORAL

Three money values offered as alternatives to cocaine.

Cocaine HCl

Intervention Type DRUG

3 mg/70 kg is available as an alternative to money.

$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.

Group Type EXPERIMENTAL

Money

Intervention Type BEHAVIORAL

Three money values offered as alternatives to cocaine.

Cocaine HCl

Intervention Type DRUG

3 mg/70 kg is available as an alternative to money.

$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.

Group Type EXPERIMENTAL

Money

Intervention Type BEHAVIORAL

Three money values offered as alternatives to cocaine.

Cocaine HCl

Intervention Type DRUG

3 mg/70 kg is available as an alternative to money.

Interventions

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Money

Three money values offered as alternatives to cocaine.

Intervention Type BEHAVIORAL

Cocaine HCl

3 mg/70 kg is available as an alternative to money.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Joshua A. Lile, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Joshua A. Lile, Ph.D.

Professor of Behavioral Science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joshua Lile, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01DA045023

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BED(In)(41)

Identifier Type: -

Identifier Source: org_study_id

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