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Phase I Randomized, Double-blind, Placebo Control Study for an Anti-cocaine Vaccine
The purpose of this study is to assess the safety and preliminary efficacy of an anti-cocaine vaccine called dAd5GNE in cocaine-dependent individuals. It uses the concept of a vaccine to treat the neurological effects of cocaine by evoking "immunity" to prevent the effects of cocaine on the brain.
Details
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 150 |
| Start date | 2012-06-26 |
| Completion | 2027-12 |
Conditions
- Cocaine Dependence
Interventions
- dAd5GNE Vaccine
- Placebo
Primary outcomes
- Safety of dAd5GNE vaccine — 32 weeks
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes a general assessment. - Safety of dAd5GNE vaccine — 32 weeks
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes a blood test. - Safety of dAd5GNE vaccine — 32 weeks
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes urinalysis. - Safety of dAd5GNE vaccine — 32 weeks
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes chest x-ray. - Safety of dAd5GNE vaccine — 32 weeks
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes ophthalmology exam. - Safety of dAd5GNE vaccine — 32 weeks
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes EKG.
Countries
United States