Cocaine Vaccine
Research Study
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Indivduals
New York, NY
Compensation Provided
Cocaine Dependence
32-week Study
21-69 Years Old
Fast Facts
About this research study:
The purpose of this study is to assess the safety and preliminary efficacy of an anti-cocaine vaccine called dAd5GNE in cocaine-dependent individuals.
This is a Phase I dose-ranging, placebo-controlled, double-blind study assessing the safety and effectiveness of an anti-cocaine vaccine called "dAd5GNE vaccine". The vaccine is designed to prevent cocaine from reaching the brain by evoking "immunity." The vaccine induces 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, therefore, reducing the effects of cocaine.
Additional Information
Why is this study being done?
Cocaine abuse is a major societal and medical problem, for which there is no effective therapy.

The goal of this study is to:
1. Assess the safety and toxicity of the direct administration of the dAd5GNE vaccine
2. Establish a maximum tolerable dose, and
3. Generate preliminary data regarding the dAd5GNE vaccine and cocaine use in addicted persons.
Is this study for me?
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 the study Psychiatrist's clinical team. Each case will be reviewed with the Eligibility Committee, comprised of three investigators other than the Principal Investigator (PI), to determine eligibility. The PI 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.
  5. Fertile males and females must agree to use adequate forms of contraception for the duration of the entire study.
  6. Body weight > 45 kg.
Exclusion Criteria:
  1. Individuals not deemed in good overall health by the investigator.
  2. Diagnosed history of severe psychotic disorders.
  3. Abnormal EKG at screening with changes consistent with cardiac disease.
  4. History of significant cardiovascular disease, hypertension, prior myocardial infarction, and/or cerebrovascular event.
  5. Individuals who are currently on beta-blockers.
  6. Physical signs or laboratory values suggestive of systemic disorders.
  7. History of attempted suicide, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) and/or committed homicide.
  8. History of diagnosed obsessive-compulsive disorder (OCD).
  9. Known allergy to soy.
  10. Individuals who are currently taking alprazolam (Xanax) or ziprasidone (Geodon).
  11. Evidence of active infection of any type, or positive for human immunodeficiency virus (HIV).
  12. Historical or current use of immunomodulators or immunosuppressants <5 years prior to screening.
  13. Receipt of blood within 3 months of screening.
  14. Females who are pregnant or nursing.
  15. Concurrent participation in any other FDA-approved Investigational New Drug.
  16. Abnormal liver function (transaminases greater than 2x the upper limit of normal values).
  17. eGFR <30 mL/min/1.73 m2
  18. History of any seizure disorder.
  19. Individuals with history of Guillain-BArre Syndrome.
  20. Diagnosis of >2 Substance Use Related Disorders (mild) based on DSM-V- TR criteria (excluding nicotine, caffeine, alcohol, marijuana, and opiates prescribed for medication-assisted therapy or pain treatment).
  21. On a prescribed agonist medication, with criteria for dependence or abuse for that class of medication for at least the past month (except tolerance to, or withdrawal from, the agonist).
  22. Severe substance use disorder based on DSM-V-TR criteria (excluding cocaine, nicotine, caffeine, alcohol, marijuana, and opiates prescribed for medication-assisted therapy or pain treatment) currently not in remission according to one of the following criteria:
  • Early Full Remission: This specifier is used if none of the criteria for Dependence or Abuse have been met for at least 1 month, but less than 12 months OR
  • Early Partial Remission: This specifier is used if only one or more (but not all) of the criteria for Dependence or Abuse has/have been met for at least 1 month, but less than 12 months. OR
  • Sustained Full Remission: This specifier is used if none of the criteria for Dependence or Abuse have been met at any time during a period of 12 months or longer OR
  • Sustained Partial Remission: This specifier is used if only one or more (but not all) of the criteria for Dependence or Abuse has/have been met for a period of 12 months or longer OR
  • On Agonist Therapy: This specifier is used if the individual is on a prescribed agonist medication, and none of the criteria for Depenednece or Abuse has been met for that class of medication for at least the past month (except tolerance to, or withdrawal from, the agonist). This category also applies to those being treated for Dependence using a partial agonist or an agonist/antagonist OR
  • Substance Usse Related Disorder (mild) up to two disorders: Patients that are assessed to have mild substance-use-related disorders according to the DSM-V criteria will be allowed to participate in the study as long as the number of the disorders-resulting substances does not exceed two (with the exception of the nicotine, caffeine, alcohol, marijuana, and opiates prescribed for medication assisted therapy or pain treatment). 
How long would I take part in this research?
The study will take place over a period of 32 weeks from the time of the first vaccine administration with an additional follow-up in 1 year.
What will happen if I participate in the study?
Subjects will receive the dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.
Will I be paid for being in this research study?
In total, you have the opportunity to earn up to $2400 for participation in this study. Qualified participants may receive study-related tests and individual counseling.
Will it cost me anything to participate in this study?
There will be no cost to you to participate in the study.