Impulsivity and Stimulant Administration

Completed · Phase 1 · Has a placebo group

Conditions studied: Cocaine Dependence, Impulsivity

In brief

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

Key facts

Study ID

NCT01978431

Run by

Yale University

People needed

29

Starts

2012-11-01

Expected to finish

2014-05-01

Last updated by the study team

2023-02-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Connecticut Mental Health Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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