Back to resultsImpulsivity and Stimulant Administration
Primary Purpose
Cocaine Dependence, Impulsivity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cocaine hydrochloride
methylphenidate
Sponsored by
About this trial
This is an interventional basic science trial for Cocaine Dependence
Eligibility Criteria
Inclusion Criteria:
- age 18 - 50 years,
- voluntary, written, informed consent,
- physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
- DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
- recent street cocaine use in excess of amounts to be administered in the current study,
- intravenous and/or smoked (crack/ freebase) use,
- positive urine toxicology screen for cocaine,
- for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.
Exclusion Criteria:
- Other drug dependence (except nicotine) as determined by urine toxicology or interview
- < 1 year of cocaine dependence,
- a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
- a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
- current use of psychotropic and/or potentially psychoactive prescription medication,
- seeking treatment for drug abuse/dependence (for experimental cocaine component),
- physical or laboratory (β-HCG) evidence of pregnancy.
- current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
Sites / Locations
- Connecticut Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Stimulant
Placebo
Arm Description
Cocaine and Methylphenidate
methylphenidate
Outcomes
Primary Outcome Measures
Mean cocaine inter-infusion interval
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.
Secondary Outcome Measures
Stop Signal Reaction Time (Impulsivity)
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)
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).
Full Information
NCT ID
NCT01978431
First Posted
October 17, 2013
Last Updated
February 14, 2023
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01978431
Brief Title
Impulsivity and Stimulant Administration
Official Title
Impulsivity and Stimulant Administration
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Impulsivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stimulant
Arm Type
Experimental
Arm Description
Cocaine and Methylphenidate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
methylphenidate
Intervention Type
Drug
Intervention Name(s)
cocaine hydrochloride
Intervention Type
Drug
Intervention Name(s)
methylphenidate
Primary Outcome Measure Information:
Title
Mean cocaine inter-infusion interval
Description
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.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Stop Signal Reaction Time (Impulsivity)
Description
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).
Time Frame
5 years
Title
Inter-Temporal Choice (Impulsivity)
Description
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).
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18 - 50 years,
voluntary, written, informed consent,
physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
recent street cocaine use in excess of amounts to be administered in the current study,
intravenous and/or smoked (crack/ freebase) use,
positive urine toxicology screen for cocaine,
for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.
Exclusion Criteria:
Other drug dependence (except nicotine) as determined by urine toxicology or interview
< 1 year of cocaine dependence,
a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
current use of psychotropic and/or potentially psychoactive prescription medication,
seeking treatment for drug abuse/dependence (for experimental cocaine component),
physical or laboratory (β-HCG) evidence of pregnancy.
current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
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