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Impulsivity and Stimulant Administration

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Robert Malison, Yale University
ClinicalTrials.gov Identifier:
NCT01978431
First received: October 17, 2013
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Cocaine Dependence
Impulsivity
Drug: cocaine hydrochloride
Drug: methylphenidate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Impulsivity and Stimulant Administration

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Mean cocaine inter-infusion interval [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 48
Study Start Date: November 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stimulant
Cocaine and Methylphenidate
Drug: cocaine hydrochloride Drug: methylphenidate
Placebo Comparator: Placebo
methylphenidate
Drug: methylphenidate

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age 18 - 50 years,
  2. voluntary, written, informed consent,
  3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
  4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
  5. recent street cocaine use in excess of amounts to be administered in the current study,
  6. intravenous and/or smoked (crack/ freebase) use,
  7. positive urine toxicology screen for cocaine,
  8. 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:

  1. Other drug dependence (except nicotine) as determined by urine toxicology or interview
  2. < 1 year of cocaine dependence,
  3. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
  4. 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).
  5. current use of psychotropic and/or potentially psychoactive prescription medication,
  6. seeking treatment for drug abuse/dependence (for experimental cocaine component),
  7. physical or laboratory (β-HCG) evidence of pregnancy.
  8. current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01978431

Contacts
Contact: Edward Gaiser 203-903-7795

Locations
United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Edward Gaiser, BA    203-974-7584      
Sponsors and Collaborators
Yale University
  More Information

No publications provided

Responsible Party: Robert Malison, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01978431     History of Changes
Other Study ID Numbers: 1001006250
Study First Received: October 17, 2013
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Impulsive Behavior
Central Nervous System Stimulants
Cocaine
Methylphenidate
Anesthetics
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 19, 2014