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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT02455479
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cocaine Dependence

Eligibility Criteria

Sex
ALL
Age
21 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • dAd5GNE Vaccine — BIOLOGICAL
    dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
  • Placebo — BIOLOGICAL
    dAd5GNE Vaccine or Placebo dAd5GNE Vaccine

Study Details

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.

Key Dates

Start date
Jun 26, 2012
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Cohort 1: 100µg
    Subjects will receive 100µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.
  • Other: Cohort 2: 316 µg
    Subjects will receive 316 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.
  • Other: Cohort 3: 1000µg
    Subjects will receive 1000 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.

Primary Outcome Measure

Safety of dAd5GNE vaccine [ Time Frame: 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
WCMC Department of Genetic MedicineNew YorkNew York10021
Sandra Hyde
[email protected]
646-962-2672
Niamh Savage
[email protected]
Ronald Crystal, MD (PRINCIPAL_INVESTIGATOR)

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By research site
WCMC Department of Genetic Medicine· New York, NY

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