RecruitingPhase 1

Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals

United States150 participantsStarted 2012-06-26

Plain-language 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.

Who can participate

Age range21 Years – 69 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Safety of dAd5GNE vaccine

Timeframe: 32 weeks

Safety of dAd5GNE vaccine

Timeframe: 32 weeks

Safety of dAd5GNE vaccine

Timeframe: 32 weeks

Safety of dAd5GNE vaccine

Timeframe: 32 weeks

Safety of dAd5GNE vaccine

Timeframe: 32 weeks

Safety of dAd5GNE vaccine

Timeframe: 32 weeks

Trial details

NCT IDNCT02455479

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Sandra Hyde

646-962-2672 sah2003@med.cornell.edu

View on ClinicalTrials.gov More Cocaine Dependence trials

Who can participate

Age range21 Years – 69 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.
✕. 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.