Neurobehavioral Mechanisms of Cocaine Choice

Early Phase 1

Completed

• Conditions: Cocaine Use Disorder
• Interventions: Behavioral: Money; Drug: Cocaine HCl

• Registration Number: NCT04296006
• Lead Sponsor: Joshua A. Lile, Ph.D.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-05
• Study Start: 2021-01-15
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01
• Results First Submitted: 2025-02-11
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Results First Posted: 2025-04-03
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
$0.25 alternative reinforcer value	Money	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.
$0.25 alternative reinforcer value	Cocaine HCl	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.
$1.00 alternative reinforcer value	Money	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.
$1.00 alternative reinforcer value	Cocaine HCl	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.
$4.00 alternative reinforcer value	Money	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.
$4.00 alternative reinforcer value	Cocaine HCl	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.

Primary Outcome Measures

Name	Time	Method
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 when three amounts of money are available as alternatives to cocaine. Each money value is tested in a separate session.

Trial Locations

Locations (1)

Laboratory of Human Behavioral Pharmacology; 🇺🇸 Lexington, Kentucky, United States