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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 5, 2018

Interventions

  • Drug: Cocaine
  • Drug: Sustained Release d-Amphetamine

Arms, Groups and Cohorts

  • Experimental: Active Treatment
    • Cocaine choice during d-amphetamine maintenance
  • Placebo Comparator: Placebo Treatment
    • Cocaine choice during placebo maintenance

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Joshua A. Lile, Ph.D.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Joshua A. Lile, Ph.D., Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science – University of Kentucky

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