Impulsivity and Stimulant Administration

Yale University

Status and phase: Completed; Phase 1

Conditions: Cocaine Dependence; Impulsivity

Treatments: Drug: cocaine hydrochloride; Drug: methylphenidate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01978431

R25MH071584 (U.S. NIH Grant/Contract)

1001006250

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

Stimulant

Experimental group

Description:

Cocaine and Methylphenidate

Treatment:

Drug: methylphenidate

Drug: cocaine hydrochloride

Placebo

Placebo Comparator group

Description:

methylphenidate

Treatment:

Drug: methylphenidate