NCT02455479

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
19mo left

Started Jun 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2012Dec 2027

Study Start

First participant enrolled

June 26, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

14.4 years

First QC Date

May 19, 2015

Last Update Submit

October 21, 2025

Conditions

Cocaine Dependence

Keywords

cocaine vaccinecocaine dependenceCocaine

Outcome Measures

Primary Outcomes (6)

  • Safety of dAd5GNE vaccine

    The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes a general assessment.

    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.

    32 weeks

  • Safety of dAd5GNE vaccine

    The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes urinalysis.

    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.

    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.

    32 weeks

  • Safety of dAd5GNE vaccine

    The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes EKG.

    32 weeks

Secondary Outcomes (2)

  • Urine cocaine metabolites

    32 weeks

  • Anti-cocaine antibody levels over time

    32 weeks

Other Outcomes (4)

  • For Information Only

    32 weeks

  • For Information Only

    32 weeks

  • For Information Only

    32 weeks

  • +1 more other outcomes

Study Arms (3)

Cohort 1: 100µg

OTHER

Subjects will receive 100µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.

Biological: dAd5GNE VaccineBiological: Placebo

Cohort 2: 316 µg

OTHER

Subjects will receive 316 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.

Biological: dAd5GNE VaccineBiological: Placebo

Cohort 3: 1000µg

OTHER

Subjects will receive 1000 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.

Biological: dAd5GNE VaccineBiological: Placebo

Interventions

dAd5GNE VaccineBIOLOGICAL

dAd5GNE Vaccine or Placebo dAd5GNE Vaccine

Cohort 1: 100µgCohort 2: 316 µgCohort 3: 1000µg
PlaceboBIOLOGICAL

dAd5GNE Vaccine or Placebo dAd5GNE Vaccine

Cohort 1: 100µgCohort 2: 316 µgCohort 3: 1000µg

Eligibility Criteria

Age21 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • \. Fertile males and females must agree to use adequate forms of contraception for the duration of the entire study.
  • \. Body weight \> 45 kg.
  • 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.
  • 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.
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WCMC Department of Genetic Medicine

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Ronald G Crystal, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Hyde

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 27, 2015

Study Start

June 26, 2012

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

October 23, 2025

Record last verified: 2025-10

Locations

US(1)