Cocaine Dependence
Conditions
Keywords
cocaine vaccine, cocaine dependence, Cocaine
Brief 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.
Detailed 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 when a person takes cocaine and prevents the cocaine molecules from reaching the brain. This cocaine-antibody complex is not able to cross the blood brain barrier and thus eliminates the effects of cocaine on the brain, as seen in pre-clinical studies done by our group. In mice, rats and nonhuman primates, this vaccine evoked a persistent, high titer, high affinity IgG anti-cocaine antibody response. The pre-clinical studies conducted establish efficacy for high anti-cocaine antibody titers. The immunity sequesters parenterally administered cocaine in the blood, in mice, rats and nonhuman primates (Appendix I-III). For each subject, the study will take place over a period of 32 weeks from the time of the first vaccine administration, and will enroll cocaine addicts, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, Text Revisions (DSM-V-TR).
Interventions
BIOLOGICALdAd5GNE Vaccine
dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
BIOLOGICALPlacebo
dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
Sponsors
Weill Medical College of Cornell University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
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 all inclusion criteria and none of the
Exclusion criteria
in order to participate in this study. Inclusion Criteria: 1. All subjects should be able to provide informed consent. 2. Must provide HIV informed consent. 3. Males and females, 21- 69 years of age. 4. Individuals that have been diagnosed with a cocaine use disorder according to DSM-V-TR criteria, with documented evidence of cocaine use within the past 60 days and have previously used an average of 1 to 10 grams of powdered and/or crack cocaine (via insufflation or smoking only) per week. Any prior 1 to 4 month period of cocaine abstinence in the past year will be excluded when calculating average cocaine use to evaluate study eligibility. 6\. Fertile males and females must agree to use adequate forms of contraception for the duration of the entire study. 7\. Body weight \> 45 kg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine cocaine metabolites | 32 weeks | Urine will be tested for benzoylecgonine (BE). The accepted value for a positive urine cocaine is urine BE of ≥ 300 ng/mL. |
| Anti-cocaine antibody levels over time | 32 weeks | The primary endpoint is average cocaine titers (week 10 - week 22) \> 4.0 x 105 titer units. |
Countries
United States
Contacts
CONTACTSandra Hyde
PRINCIPAL_INVESTIGATORRonald G Crystal, MD
Weill Medical College of Cornell University
Outcome results
None listed