Impulsivity and Stimulant Administration | NCT01978431 | Trialant
CompletedInterventionalPhase 1Updated Feb 16, 2023
Impulsivity and Stimulant Administration
Impulsivity and Stimulant Administration
ClinicalTrials.gov ID
NCT01978431
Lead Sponsor
Yale UniversityOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
29Actual
Last Update Posted
Feb 16, 2023Actual
Start Date
Nov 2012Actual
Primary Completion Date
May 2014Actual
Completion Date
May 2014Actual
Official Title
Impulsivity and Stimulant Administration
Brief Summary
Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity.
Cocaine Dependence
Impulsivity
cocaine hydrochloride
methylphenidate
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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.