- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978431
Impulsivity and Stimulant Administration
February 14, 2023 updated by: Gustavo Angarita, Yale University
Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- 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
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Connecticut Mental Health Center
-
-
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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
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: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stimulant
Cocaine and Methylphenidate
|
|
Placebo Comparator: Placebo
methylphenidate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
5 years
|
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).
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
November 1, 2012
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
October 17, 2013
First Submitted That Met QC Criteria
October 31, 2013
First Posted (Estimate)
November 7, 2013
Study Record Updates
Last Update Posted (Estimate)
February 16, 2023
Last Update Submitted That Met QC Criteria
February 14, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Impulsive Behavior
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- 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
- Vasoconstrictor Agents
- Methylphenidate
- Cocaine
Other Study ID Numbers
- 1001006250
- R25MH071584 (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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