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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

Tracking Information
First Submitted Date  ICMJE February 27, 2015
First Posted Date  ICMJE March 9, 2015
Results First Submitted Date  ICMJE January 30, 2019
Results First Posted Date  ICMJE April 11, 2019
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE February 1, 2015
Actual Primary Completion Date April 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
Number of Injections of self-administered cocaine [ Time Frame: 33 days ]
Change History Complete list of historical versions of study NCT02383043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
Official Title  ICMJE Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Active Cocaine Users
Intervention  ICMJE
  • Drug: Cocaine
  • Drug: Sustained Release d-Amphetamine
    Other Name: Dexedrine Spansule SR
Study Arms  ICMJE
  • Experimental: Active Treatment
    Cocaine choice during d-amphetamine maintenance
    Interventions:
    • Drug: Cocaine
    • Drug: Sustained Release d-Amphetamine
  • Placebo Comparator: Placebo Treatment
    Cocaine choice during placebo maintenance
    Interventions:
    • Drug: Cocaine
    • Drug: Sustained Release d-Amphetamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2015)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 5, 2018
Actual Primary Completion Date April 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02383043
Other Study ID Numbers  ICMJE R01DA033364-02( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joshua A. Lile, Ph.D., University of Kentucky
Study Sponsor  ICMJE Joshua A. Lile, Ph.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Kentucky
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP