Actively Recruiting
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Led by Weill Medical College of Cornell University · Updated on 2025-10-23
150
Participants Needed
1
Research Sites
805 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Provide HIV informed consent
- Male or female aged 21 to 69 years
- Diagnosed with cocaine use disorder by DSM-V-TR criteria
- Documented cocaine use within past 60 days
- Average use of 1 to 10 grams of powdered or crack cocaine weekly (via insufflation or smoking)
- Fertile males and females agree to use adequate contraception during the study
- Body weight greater than 45 kg
You will not qualify if you...
- Not in good overall health as determined by investigator
- History of severe psychotic disorders
- Abnormal EKG indicating cardiac disease
- History of significant cardiovascular disease, hypertension, prior heart attack, or stroke
- Currently on beta-blocker medication
- Signs or lab values indicating systemic disorders
- History of suicide attempts or homicide
- Diagnosed obsessive-compulsive disorder (OCD)
- Allergy to soy
- Currently taking alprazolam or ziprasidone
- Active infection including COVID-19 or positive HIV test
- Use of immunomodulators or immunosuppressants within 5 years prior to screening
- Received blood transfusion within 3 months before screening
- Pregnant or nursing females
- Participating in another FDA-approved investigational drug study
- Abnormal liver function with transaminases >2 times normal
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2
- Severe substance use disorder not in remission excluding certain substances
- History of seizure disorder
- History of Guillain-Barré Syndrome
- More than 2 mild substance use disorders excluding nicotine, caffeine, alcohol, marijuana, and prescribed opiates
- On prescribed agonist medication with active dependence or abuse within past month
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
WCMC Department of Genetic Medicine
New York, New York, United States, 10021
Actively Recruiting
Research Team
S
Sandra Hyde
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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