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

NCT01437293 | Completed Phase 1 DMC

• 3 other identifiers: #6141 P50 DA 009236-16P50DA009236P50DA009236-16
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 which participants will have two cocaine-administration sessions, each including five doses of smoked cocaine with ascending doses.

Conditions

Cocaine Abuse

Keywords

cocaine

Outcome Measures

Primary Outcomes (2)

• Blood pressure

  Maximum SBP, maximum DPB will be obtained at baseline, prior to the first session dose, and after each consecutive dose (0, 6, 12, 25, 50, 50 mg). Changes from baseline in blood pressure in the used by cocaine administration under placebo condition will be compared to those obtained during treatment with LCE using repeated measures ANOVA.

  (baseline) prior to and after each of the 6 cocaine administrations at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose

• heart rate

  Heart rate will be obtained at baseline, prior to the first session dose, and after each consecutive dose (0, 6, 12, 25, 50, 50mg). Changes from baseline in heart rate in the used by cocaine administration under placebo condition will be compared to those obtained during treatment with LCE using repeated measures ANOVA.

  (baseline) prior to and after each of the 6 cocaine administrations at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose

Secondary Outcomes (2)

• Composite (or Profile) of Pharmacokinetics

  18, 32, 46, 60, 74, 104 minutes post dose

• subjective cocaine experience

  Done at baseline and at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose

Study Arms (1)

Experimental

EXPERIMENTAL

L-dopa / carbidopa / entacapone (LCE)

Drug: L-dopa / carbidopa / entacapone (LCE)

Interventions

L-dopa / carbidopa / entacapone (LCE) DRUG

For this trial we propose a target dosage of L-dopa / carbidopa / entacapone of 400 mg L-dopa / 100mg carbidopa / 200 mg entacapone, twice daily.

Also known as: L/C/E

Experimental

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Columbia University: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• stars website

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Levodopa; Carbidopa; entacapone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines

Study Officials

• Adam Bisaga, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: September 20, 2011
• Study Start: August 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

US (1)