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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-69
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • dAd5GNE Vaccine
  • Placebo

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Weill Medical College of Cornell University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator