Expired Study
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New Haven, Connecticut 06519


Purpose:

Cocaine dependence is a major public health problem; an effective treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to evaluate the effectiveness of the cocaine vaccine candidate TA-CD in treating cocaine dependent individuals.


Study summary:

Cocaine is a highly addictive stimulant that has high abuse potential. An effective drug to treat cocaine dependent individuals has yet to be found. Cocaine produces euphoric effects by blocking the re-uptake of neurotransmitters, such as dopamine, within the brain. The vaccine candidate TA-CD is a cocaine derivative coupled to recombinant cholera toxin B. It is designed to generate drug-specific antibodies that bind to cocaine and prevent it from travelling to the brain from the blood, thereby neutralizing its psychoaffective effect. The purpose of this study is to evaluate the effectiveness of TA-CD versus placebo in treating cocaine dependent individuals.


Criteria:

Inclusion Criteria: - Moderate to severe cocaine or opioid dependence - Willing to enroll in methadone maintenance treatment - Demonstrates motivation to stop using cocaine - In good general health - If female, willing to use an adequate form of contraception for the duration of the study Exclusion Criteria: - Currently suicidal or experiencing psychosis - History of psychosis or schizophrenia - Inability to read or understand English - Current dependence on drugs or alcohol other than cocaine, opiates, or tobacco - History of uveitis or ocular abnormalities associated with uveitis - Any concomitant disease or abnormalities that, in the opinion of the investigator, may interfere with the study - Requires psychotropic medications or steroids within 30 days of study entry - Immune deficiency - Ongoing active infection - HIV infected - Pregnant


NCT ID:

NCT00142857


Primary Contact:

Principal Investigator
Thomas R. Kosten, MD
Yale University, Department of Psychiatry


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06519
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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