CompletedPhase 1

Impulsivity and Stimulant Administration

United States29 participantsStarted 2012-11

Plain-language summary

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

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Mean cocaine inter-infusion interval

Timeframe: 3 hours

NCT IDNCT01978431

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-05

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.