Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer

Early Phase 1CompletedNCT02383043

Joshua A. Lile, Ph.D.18 enrolled

Overview

Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Active Cocaine Users

Interventions

CocaineDRUG

Sustained Release d-AmphetamineDRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative

The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance.

Time frame: 9 choice trials per cocaine dose level with each trial separated by 30 minutes

Data from ClinicalTrials.gov

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