Original articleVaccine Pharmacotherapy for the Treatment of Cocaine Dependence
Section snippets
Methods and Materials
This was a fourteen week, open label, dose escalation clinical trial designed to test the safety and immunogenicity of two doses of a phase IIa human cocaine vaccine (TA-CD) (400 μg and 2000 μg total dose groups). Both groups were cocaine dependent persons in early recovery who were followed prospectively for evidence of established abstinence and subsequent signs of relapse during fourteen weeks of outpatient treatment and at a 6 month follow-up time point. Subjects were contacted and asked to
Subject Characteristics
Baseline clinical characteristics of participants are listed in Table 1. Overall, on average, subjects were 41 years of age, male, ethnically black, and smoked cocaine. There was no difference between the 400 μg and 2000 μg groups with regard to age, sex, race, age of first cocaine use, or length of time using cocaine. The 400 μg group used cocaine by all routes, whereas the 2000 μg group did not use cocaine intravenously or by lacing it. Cannabis was the only other illicit substance identified
Discussion
To our knowledge, this is the only immunotherapy for cocaine abuse currently being tested in humans. This open label study was designed to test the safety of this novel immunotherapy and examine the concept that cocaine specific antibodies can be generated, can bind to and sequester cocaine molecules sufficiently such that cocaine use is attenuated. The administration of the cocaine vaccine through a series of four to five injections at doses totaling either 400 or 2000 μg proved to be well
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