Status:
COMPLETED
Behavioral and Physiological Effects of Cocaine in Cocaine-dependent Participants Treated With Levodopa in Combination With Carbidopa and Entacapone (LCE)
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Columbia University
Conditions:
Cocaine Abuse
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief 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 wh...
Detailed Description
Cocaine dependence remains a serious public health problem; however no clearly effective pharmacological treatments have been identified to date. We hypothesize that identification of subgroups of coc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01437293
Start Date
August 1 2010
End Date
April 1 2012
Last Update
May 21 2018
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032