Overview

Behavioral and Physiological Effects of Cocaine in Cocaine-dependent Participants Treated With Levodopa in Combination With Carbidopa and Entacapone (LCE)

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
Summary
An inpatient safety study to characterize the cardiovascular and behavioral effects of cocaine administration in the presence of LCE. The proposed study involves an inpatient stay of 12 days during which participants will have two cocaine-administration sessions, each including five doses of smoked cocaine with ascending doses.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborators:
Columbia University
National Institute on Drug Abuse (NIDA)
Treatments:
Carbidopa
Cocaine
Entacapone
Levodopa
Criteria
Inclusion Criteria:

- Adult, age 21-50.

- Smokes cocaine on average at least 1x/week; currently spends at least $30/week on
cocaine. Has been using cocaine for at least 6 months Urine toxicology positive for
cocaine metabolites

- Has patterns of smoked cocaine use in terms of frequency and amount that parallels or
exceed those administered in the study

- Able to give informed consent and comply with study procedures

Exclusion Criteria:

- Current DSM-IV criteria of substance use disorders with the exception of cocaine or
nicotine dependence, or a history of alcohol or cannabis dependence.

- Request for drug treatment

- Unstable medical disorders, or medical disorders that might interfere with study
participation, including current seizure disorder, heart disease or a history of
serious adverse effects due to cocaine.

- Judged to be noncompliant with study protocol

- Concurrent use of any psychotropic medications

- Concurrent use of MAO inhibitors or epinephrine (patients must be off MAOIs for a
minimum of 2 weeks)

- Clinical laboratory tests outside normal limits that are clinically unacceptable to
the study physician (systolic BP > 140 and < 90, diastolic BP > 90 and < 60, and heart
rate > 90; BUN, creatinine, LFTs > ULN; hematocrit < 34 for women, < 36 for men;
pseudocholinesterase deficiency)

- Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory
method of birth control

- History of myocardial infarction or ischemia, clinically significant left ventricular
hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse

- History of narrow angle glaucoma or prostate cancer

- History of melanoma or current suspicious undiagnosed skin lesions

- Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other
than transient psychosis due to drug abuse

- History of allergic reaction or adverse reaction to study medications
(levodopa/carbidopa/entacapone).

- Current parole or probation