Cocaine DependencePhase 1NCT02455479
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
A Phase 1 study testing dAd5GNE Vaccine in people with Cocaine Dependence, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- dAd5GNE Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2016to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects should be able to provide informed consent.
- Must provide HIV informed consent.
- Males and females, 21- 69 years of age.
- 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.
Who cannot join
- Individuals not deemed in good overall health by the investigator.
- Diagnosed history of severe psychotic disorders.
- Abnormal EKG at screening with changes consistent with cardiac disease.
- History of significant cardiovascular disease, hypertension, prior myocardial infarction and/or cerebrovascular event.
- Individuals who are currently on beta-blockers.
- Physical signs or laboratory values suggestive of systemic disorders.
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- History of attempted suicide, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) and/or committed homicide.
- History of diagnosed obsessive compulsive disorder (OCD).
- Known allergy to soy.
- Individuals who are currently taking alprazolam (Xanax) or ziprasidone (Geodon).
- Evidence of active infection of any types, including COVID-19, or positive for human immunodeficiency virus (HIV).
- Historical or current use of immunomodulators or immunosuppressants <5 years prior to screening.
- Receipt of blood within 3 months of screening.
- Females who are pregnant or nursing.
- Concurrent participation in any other FDA approved Investigational New Drug.
- Abnormal liver function (transaminases greater than 2x the upper limit of normal values)
- eGFR <30 mL/min/1.73 m2
- 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 Dependence 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 Use 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 disorder-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).
- History of any seizure disorder.
- Individuals with history of Guillain-Barré Syndrome.
- 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
- On a prescribed agonist medication, with criteria for dependence or abuse for that class ofmedication for at least the past month (except tolerance to, or withdrawal from, the agonist
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
WCMC Department of Genetic Medicine
New York, New York, 10021
Sandra Hyde, 646-962-2672, sah2003@med.cornell.edu
Niamh Savage, nis2049@med.cornell.edu
About this study
Official title: 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.
Read the 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).
- Conditions
- Cocaine Dependence
- Being tested
- dAd5GNE Vaccine, Placebo
- Keywords
- cocaine vaccine, cocaine dependence, Cocaine
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dAd5GNE VaccineBiological
dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
PlaceboBiological
dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 100µg | Other | Subjects will receive 100µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20. Receives: Biological: dAd5GNE Vaccine; Biological: Placebo |
| Cohort 2: 316 µg | Other | Subjects will receive 316 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20. Receives: Biological: dAd5GNE Vaccine; Biological: Placebo |
| Cohort 3: 1000µg | Other | Subjects will receive 1000 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20. Receives: Biological: dAd5GNE Vaccine; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes a general assessment.
Measured: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes a blood test.
Measured: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes urinalysis.
Measured: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes chest x-ray.
Measured: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes ophthalmology exam.
Measured: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes EKG.
Measured: 32 weeks
Secondary outcomes (2)
Urine cocaine metabolites
Urine will be tested for benzoylecgonine (BE). The accepted value for a positive urine cocaine is urine BE of ≥ 300 ng/mL.
Measured: 32 weeks
Anti-cocaine antibody levels over time
The primary endpoint is average cocaine titers (week 10 - week 22) > 4.0 x 105 titer units.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study start13 Sep 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ronald G Crystal, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455479
- Sponsor's protocol ID
- 1206012440
- Other IDs
- U01DA048524
- Status last verified
- Aug 2026
- First submitted
- 19 May 2015
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomized, Double-blind, Placebo Control Study for an Anti-cocaine Vaccine
- ClinicalTrials.gov ID
- NCT02455479
- Acronym / sponsor ID
- 1206012440
- Conditions
- Cocaine Dependence
- Keywords
- cocaine vaccine, cocaine dependence, Cocaine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 100µg | Other | Biological: dAd5GNE Vaccine, Biological: PlaceboSubjects will receive 100µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20. |
| Cohort 2: 316 µg | Other | Biological: dAd5GNE Vaccine, Biological: PlaceboSubjects will receive 316 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20. |
| Cohort 3: 1000µg | Other | Biological: dAd5GNE Vaccine, Biological: PlaceboSubjects will receive 1000 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20. |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All subjects should be able to provide informed consent.
- Must provide HIV informed consent.
- Males and females, 21- 69 years of age.
- 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.
Key exclusion criteria (28 listed)
- Individuals not deemed in good overall health by the investigator.
- Diagnosed history of severe psychotic disorders.
- Abnormal EKG at screening with changes consistent with cardiac disease.
- History of significant cardiovascular disease, hypertension, prior myocardial infarction and/or cerebrovascular event.
- Individuals who are currently on beta-blockers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dAd5GNE VaccinedAd5GNE Vaccine or Placebo dAd5GNE Vaccine | Biological | Cohort 1: 100µg, Cohort 2: 316 µg, Cohort 3: 1000µg |
| PlacebodAd5GNE Vaccine or Placebo dAd5GNE Vaccine | Biological | Cohort 1: 100µg, Cohort 2: 316 µg, Cohort 3: 1000µg |
Primary outcome
Safety of dAd5GNE vaccine
Time frame: 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
Time frame: 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
Time frame: 32 weeks
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes urinalysis.
Safety of dAd5GNE vaccine
Time frame: 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
Time frame: 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
Time frame: 32 weeks
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes EKG.
2 secondary outcomes
Urine cocaine metabolites
Time frame: 32 weeks
Anti-cocaine antibody levels over time
Time frame: 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald G Crystal, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dAd5GNE Vaccine in people with Cocaine Dependence, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Hyde (646-962-2672, sah2003@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of dAd5GNE vaccine (time frame: 32 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.