- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02383043
Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
March 17, 2019 updated by: Joshua A. Lile, Ph.D.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kentucky
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Lexington, Kentucky, United States, 40536-0086
- Laboratory of Human Behavioral Pharmacology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Treatment
Cocaine choice during d-amphetamine maintenance
|
Other Names:
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Placebo Comparator: Placebo Treatment
Cocaine choice during placebo maintenance
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Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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9 choice trials per cocaine dose level with each trial separated by 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Actual)
April 5, 2018
Study Completion (Actual)
April 5, 2018
Study Registration Dates
First Submitted
February 27, 2015
First Submitted That Met QC Criteria
March 3, 2015
First Posted (Estimate)
March 9, 2015
Study Record Updates
Last Update Posted (Actual)
April 11, 2019
Last Update Submitted That Met QC Criteria
March 17, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Anesthetics, Local
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Vasoconstrictor Agents
- Amphetamine
- Dextroamphetamine
- Cocaine
Other Study ID Numbers
- R01DA033364-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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