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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 32 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
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
2,607 Previous Clinical Trials
3,329,785 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,636 Total Patients Enrolled
Ronald G Crystal, MDPrincipal InvestigatorWeill Medical College of Cornell University
26 Previous Clinical Trials
5,887 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The study will randomly accept participants without any preference for gender or ethnicity. Your participation in the study will not be affected by your gender or ethnicity. All participants will also be receiving behavioral therapy from Dr. Beeder's team. An Eligibility Committee, made up of three investigators other than the main researcher, will review each participant's case to decide if they are eligible to join the study. The main researcher will not be involved in this decision-making process.I have been diagnosed with a severe psychotic disorder.I am currently taking beta-blockers.I haven't used immune system altering drugs in the last 5 years.My body weight is over 45 kg.I am on prescribed medication for dependence without abuse for the past month.My liver tests are higher than normal.My kidney function is severely reduced.I have not received a blood transfusion in the last 3 months.I do not have any active infections, including COVID-19, and I am not HIV positive.I have been dependent on or abused a prescribed medication for over a month, except for tolerance or withdrawal symptoms.I am not pregnant or nursing.I am currently taking Xanax or Geodon.I have a history of serious heart or blood vessel problems.I am between 21 and 69 years old.You must meet all the requirements to participate in the study, and cannot have any of the conditions that would disqualify you.I have a history of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3: 1000µg
- Group 2: Cohort 2: 316 µg
- Group 3: Cohort 1: 100µg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.