Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Feb 2015
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 27, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2018
CompletedResults Posted
Study results publicly available
April 11, 2019
CompletedApril 11, 2019
March 1, 2019
3.2 years
February 27, 2015
January 30, 2019
March 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
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.
9 choice trials per cocaine dose level with each trial separated by 30 minutes
Study Arms (2)
Active Treatment
EXPERIMENTALCocaine choice during d-amphetamine maintenance
Placebo Treatment
PLACEBO COMPARATORCocaine choice during placebo maintenance
Interventions
Eligibility Criteria
You may qualify if:
- Recent cocaine use, otherwise healthy
You may not qualify if:
- Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, 40536-0086, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joshua A. Lile, Ph.D.
- Organization
- University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 9, 2015
Study Start
February 1, 2015
Primary Completion
April 5, 2018
Study Completion
April 5, 2018
Last Updated
April 11, 2019
Results First Posted
April 11, 2019
Record last verified: 2019-03