drugset / Trial / NCT00965263
Therapeutic Cocaine Vaccine: Human Laboratory Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TA-CD | Vaccine | 82 ug | Intramuscular |
| Subject | TA-CD | Vaccine | 360 ug | Intramuscular |