Elsevier

Biological Psychiatry

Volume 58, Issue 2, 15 July 2005, Pages 158-164
Biological Psychiatry

Original article
Vaccine Pharmacotherapy for the Treatment of Cocaine Dependence

https://doi.org/10.1016/j.biopsych.2005.04.032Get rights and content

Background

Cocaine abuse has no established pharmacotherapy, but active immunotherapy with a cocaine vaccine shows promise as a therapeutic intervention.

Methods

An open label, fourteen week, dose-escalation study evaluated the safety, immunogenicity, and clinical efficacy of a novel human cocaine vaccine (TA-CD) in eighteen cocaine dependent subjects. Ten subjects (400 μg total dose group) received four-100 μg injections over the course of eight weeks. Subsequently, eight subjects (2000 μg total dose group) received five-400 μg vaccinations over twelve weeks. Intent to treat analysis of thrice weekly urine toxicologies and cocaine antibody titers were compared.

Results

Sixteen of 18 subjects completed the study. There were no serious adverse reactions and the vaccine was well tolerated. The 2000 μg total dose group had a significantly higher mean antibody titer response (2000 units) as compared to the 400 μg total dose group (1000 units) (p = .05). The 2000 μg group was more likely to maintain cocaine free urines than those in the 400 μg group (Z = −3.12, p = .002). Despite relapse in both groups, most reported an attenuation of cocaine's usual euphoric effects at the six month follow-up time points (63% in the 400 μg and 100% in the 2000 μg groups).

Conclusions

The conjugated cocaine vaccine was well tolerated and cocaine specific antibodies persisted at least six months. The likelihood of using cocaine decreased in subjects who received the more intense vaccination schedule.

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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