Clinical Trial: Impulsivity and Stimulant Administration

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Impulsivity and Stimulant Administration

Brief Summary: Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity.

Detailed Summary:
Sponsor: Yale University

Current Primary Outcome: Mean cocaine inter-infusion interval [ Time Frame: 3 hours ]

Subjects complete three separate 60 minute long "binge" cocaine self administration sessions (low dose 8mg/70kg, medium dose 16mg/70kg, and large dose 32mg/70kg). Mean inter-infusion intervals (time between cocaine boluses) are then averaged by adding all intervals within each session and dividing by 60. Intervals during which pump access is withheld (due to increase in vital signs) will be excluded. Data on cocaine self-administration (total number of responses, infusions, and III), subjective effects, and vital signs will be checked for normality prior to analysis using Kolmogorov-Smirnov statistics and normal probability plots. The significance level for all statistical tests will be set at p<.05.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Stop Signal Reaction Time (Impulsivity) [ Time Frame: 5 years ]
    The Dependent measures pertinent to the effects of an acute/chronic exposure to stimulants (methylphenidate/cocaine) on measures of impulsivity will be analyzed using a mixed design ANOVA. This design will have a within subjects variable to study the effects of an acute exposure to stimulants (methylphenidate vs. placebo) and a between subjects variable to study the effects of a chronic exposure to stimulants (cocaine dependent subjects vs. healthy controls).
  • Inter-Temporal Choice (Impulsivity) [ Time Frame: 5 years ]
    The Dependent measures pertinent to the effects of an acute/chronic exposure to stimulants (methylphenidate/cocaine) on measures of impulsivity will be analyzed using a mixed design ANOVA. This design will have a within subjects variable to study the effects of an acute exposure to stimulants (methylphenidate vs. placebo) and a between subjects variable to study the effects of a chronic exposure to stimulants (cocaine dependent subjects vs. healthy controls).


Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: October 17, 2013
Date Started: November 2012
Date Completion:
Last Updated: June 22, 2016
Last Verified: June 2016