Completed

NCT Number: NCT02383043

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

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.

Completed

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Key information

Conditions

Active Cocaine Users

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, 40536-0086, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocaine

Drug

Sustained Release d-Amphetamine

Drug

Other names: Dexedrine Spansule SR

Primary outcomes

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

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

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.

Sponsors and collaborators

Lead sponsor

Joshua A. Lile, Ph.D.

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Mar 9, 2015
Registry last updated: Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.