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

Early Phase 1

Completed

• Conditions: Active Cocaine Users
• Interventions: Drug: Cocaine; Drug: Sustained Release d-Amphetamine

• Registration Number: NCT02383043
• Lead Sponsor: Joshua A. Lile, Ph.D.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-01
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-09
• Primary Completion: 2018-04-05
• Study Completion: 2018-04-05
• Results First Submitted: 2019-01-30
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-17
• Last Update Submitted: 2019-03-17
• Results First Posted: 2019-04-11
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Treatment	Sustained Release d-Amphetamine	Cocaine choice during d-amphetamine maintenance
Placebo Treatment	Sustained Release d-Amphetamine	Cocaine choice during placebo maintenance
Active Treatment	Cocaine	Cocaine choice during d-amphetamine maintenance
Placebo Treatment	Cocaine	Cocaine choice during placebo maintenance

Primary Outcome Measures

Name	Time	Method
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative	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.

Trial Locations

Locations (1)

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