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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My body weight is over 45 kg.
Select...
I am between 21 and 69 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaccines
Secondary outcome measures
Anti-cocaine antibody levels over time
Urine cocaine metabolites
Other outcome measures
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
2,468 Previous Clinical Trials
2,619,198 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,159 Total Patients Enrolled
Ronald G Crystal, MDPrincipal InvestigatorWeill Medical College of Cornell University
26 Previous Clinical Trials
5,872 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors accepted as participants in this clinical investigation?

"Enrolment for this clinical trial necessitates that participants must be between 21 and 69 years old."

Answered by AI

How many participants are currently enrolled in this clinical trial?

"Affirmative, the online database on clinicaltrials.gov suggests that recruitment for this trial is currently ongoing and began on June 26th 2012. The study seeks 30 participants from 1 location and has been recently updated in March 29th 2022."

Answered by AI

What kind of demographic is best suited for participating in this trial?

"This cocaine dependence study is enrolling 30 individuals aged 21-69. The selection process will be impartial, with no preference given to gender or ethnic background. Each case must be assessed by the Eligibility Committee (comprised of three clinical investigators not including the PI) and all participants need to meet inclusion criteria while fulfilling none of the exclusion criteria in order to qualify for enrolment. Furthermore, each participant has to partake concurrently in behavioral therapy programs developed by Dr. Beeder's team."

Answered by AI

Has this therapeutic intervention been given the green light by the Food and Drug Administration?

"This new treatment is yet to be fully tested, as such we assign it a score of 1 on the safety scale. Phase 1 trials provide preliminary evidence regarding its efficacy and security."

Answered by AI

Are applications being accepted from volunteers for this research endeavor at present?

"Affirmative. According to information hosted on clinicaltrials.gov, this research project is actively seeking out eligible participants. It was first listed back in June of 2012 and its parameters were most recently updated at the end of March 2022 with a view to recruit 30 people from one site only."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
WCMC Department of Genetic Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
2012. "Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02455479.
All > Adenovirus
~7 spots leftby Dec 2024
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