drugset / Trial / NCT00965263

Therapeutic Cocaine Vaccine: Human Laboratory Study

NCT00965263 ↗

Phase 2 Completed 15 enrolled New York State Psychiatric Institute
RandomizedParallel-groupDouble-blindTreatment

Summary

Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. The objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects. Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.

Timeline

Start
2003-03
Primary completion
2009-07
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject TA-CD Vaccine 82 ug Intramuscular
Subject TA-CD Vaccine 360 ug Intramuscular

Indications