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Virus Therapy

Cocaine Vaccine for Cocaine Addiction

Phase 1
Recruiting
Led By Ronald G Crystal, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight > 45 kg.
Males and females, 21- 69 years of age.
Must not have
Diagnosed history of severe psychotic disorders.
Individuals who are currently on beta-blockers.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks

Summary

This trial is testing a new anti-cocaine vaccine to see if it is safe and effective in people addicted to cocaine. The vaccine works by causing the body to create immunity to cocaine, which would then prevent the drug's effects on the brain.

Who is the study for?
This trial is for adults aged 21-69 with cocaine use disorder, using 1-10 grams of cocaine weekly. They must be in good health, not have severe mental disorders or significant heart disease, and cannot be on certain medications like beta-blockers or immunosuppressants. Participants should agree to contraception and will also receive behavioral therapy.
What is being tested?
The study tests the safety and initial effectiveness of a new anti-cocaine vaccine called dAd5GNE. It aims to create 'immunity' against the neurological effects of cocaine. Participants are randomly assigned to receive either the vaccine or a placebo while undergoing behavioral therapy.
What are the potential side effects?
Potential side effects aren't specified but may include typical vaccine reactions such as soreness at injection site, fever, fatigue, headache, muscle pain, chills, joint pain or swelling; allergic reactions could occur in those sensitive to components like soy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body weight is over 45 kg.
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I am between 21 and 69 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a severe psychotic disorder.
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I am currently taking beta-blockers.
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My liver tests are higher than normal.
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My kidney function is severely reduced.
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I do not have any active infections, including COVID-19, and I am not HIV positive.
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I have been dependent on or abused a prescribed medication for over a month, except for tolerance or withdrawal symptoms.
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I am not pregnant or nursing.
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I am currently taking Xanax or Geodon.
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I have a history of serious heart or blood vessel problems.
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I have a history of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vaccines
Secondary study objectives
Anti-cocaine antibody levels over time
Urine cocaine metabolites
Other study objectives
For Information Only

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3: 1000µgExperimental Treatment2 Interventions
Subjects will receive 1000 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.
Group II: Cohort 2: 316 µgExperimental Treatment2 Interventions
Subjects will receive 316 µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.
Group III: Cohort 1: 100µgExperimental Treatment2 Interventions
Subjects will receive 100µg dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16 and 20.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,398 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,087 Previous Clinical Trials
1,148,597 Total Patients Enrolled
Ronald G Crystal, MDPrincipal InvestigatorWeill Medical College of Cornell University
26 Previous Clinical Trials
5,887 Total Patients Enrolled

Media Library

dAd5GNE Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02455479 — Phase 1
Cocaine Dependence Research Study Groups: Cohort 3: 1000µg, Cohort 2: 316 µg, Cohort 1: 100µg
Cocaine Dependence Clinical Trial 2023: dAd5GNE Vaccine Highlights & Side Effects. Trial Name: NCT02455479 — Phase 1
dAd5GNE Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02455479 — Phase 1
~11 spots leftby Dec 2025
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