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

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ClinicalTrials.gov Identifier: NCT02383043
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua A. Lile, Ph.D., University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Active Cocaine Users Drug: Cocaine Drug: Sustained Release d-Amphetamine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : April 5, 2018
Actual Study Completion Date : April 5, 2018


Arm Intervention/treatment
Experimental: Active Treatment
Cocaine choice during d-amphetamine maintenance
Drug: Cocaine
Drug: Sustained Release d-Amphetamine
Other Name: Dexedrine Spansule SR

Placebo Comparator: Placebo Treatment
Cocaine choice during placebo maintenance
Drug: Cocaine
Drug: Sustained Release d-Amphetamine
Other Name: Dexedrine Spansule SR




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383043


Locations
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United States, Kentucky
Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, United States, 40536-0086
Sponsors and Collaborators
Joshua A. Lile, Ph.D.
  Study Documents (Full-Text)

Documents provided by Joshua A. Lile, Ph.D., University of Kentucky:
Study Protocol  [PDF] December 17, 2017
No Statistical Analysis Plan (SAP) exists for this study.


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Responsible Party: Joshua A. Lile, Ph.D., Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science, University of Kentucky
ClinicalTrials.gov Identifier: NCT02383043     History of Changes
Other Study ID Numbers: R01DA033364-02 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2015    Key Record Dates
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Amphetamine
Dextroamphetamine
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors