Phase I Randomized, Double-blind, Placebo Control Study for an Anti-cocaine Vaccine
Weill Medical College of Cornell University
Summary
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.
Description
This is a Phase I dose-ranging, placebo-controlled, double blind study assessing the safety and preliminary efficacy of an anti-cocaine vaccine called "dAd5GNE vaccine". The vaccine is designed to prevent cocaine from reaching the brain. The vaccine is comprised of GNE, a cocaine-like molecule that is linked to the capsid protein of a disrupted serotype 5 adenovirus. The vaccine is used to evoke "immunity" to prevent cocaine from reaching the brain. The vaccine evokes an immune system response and stimulates the creation of anti-cocaine antibodies. The antibodies bind to the cocaine molecules…
Eligibility
- Age range
- 21–69 years
- Sex
- All
- Healthy volunteers
- No
Accrual will be random, with no bias as to gender or racial/ethnic group. Because the accrual process will be random, it is possible that there may be differences in the proportion of males and females, and racial/ethnic groups among the study individuals. All subjects will be concurrently participating in behavioral therapy programs run by Dr. Beeder's clinical team. Each case will be reviewed with the Eligibility Committee, comprised of three investigators other than the PI, to determine eligibility. The Principal Investigator will not participate in this process. All subjects must fulfill…
Interventions
- BiologicaldAd5GNE Vaccine
dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
- BiologicalPlacebo
dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
Location
- WCMC Department of Genetic MedicineNew York, New York