Skip to main content
OpenTrials
Completed

NCT Number: NCT01978431

Impulsivity and Stimulant Administration

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cocaine hydrochloride

Drug

Methylphenidate

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2013
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.