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