Cocaine Vaccine for Cocaine Addiction

Overseen By Sandra Hyde

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Weill Medical College of Cornell University

Must not be taking: Beta-blockers, Xanax, Geodon, Immunosuppressants

Disqualifiers: Severe psychotic disorders, Cardiovascular disease, OCD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 20 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as beta-blockers, alprazolam (Xanax), and ziprasidone (Geodon). If you are on these medications, you would need to discontinue them to participate.

What data supports the effectiveness of the cocaine vaccine treatment for cocaine addiction?

Research shows that the dAd5GNE vaccine can produce high levels of antibodies that block cocaine from reaching the brain, reducing its effects. In animal studies, this vaccine helped prevent cocaine from causing its usual stimulating effects and made it harder for animals to start using cocaine again after stopping. ^{1 2 3 4 5}

Is the cocaine vaccine dAd5GNE safe for humans?

Research on the dAd5GNE cocaine vaccine in animals, including monkeys and mice, shows that it does not cause harmful effects on major organs and does not prolong cocaine levels in the blood, suggesting it is generally safe. ^{1 2 3 5 6}

How is the dAd5GNE vaccine treatment different from other treatments for cocaine addiction?

The dAd5GNE vaccine is unique because it works by stimulating the body to produce antibodies that bind to cocaine, preventing it from reaching the brain and reducing its effects. Unlike other treatments, this vaccine specifically targets the cocaine molecule itself, aiming to block its psychoactive effects and help prevent relapse. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Ronald G Crystal, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

Inclusion 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.

My body weight is over 45 kg.

Must provide HIV informed consent.

Exclusion Criteria

- Early Partial Remission: This specifier is used if only one or more (but not all) of the criteria for Dependence or Abuse has/have been met for at least 1 month, but less than 12 months.

Known allergy to soy.

Concurrent participation in any other FDA approved Investigational New Drug.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the dAd5GNE vaccine or placebo at weeks 0, 4, 8, 12, 16, and 20

20 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• dAd5GNE Vaccine

Trial Overview 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.

Participant Groups

Group I: Cohort 3: 1000µg Experimental Treatment 2 Interventions

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

Group II: Cohort 2: 316 µg Experimental Treatment 2 Interventions

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

Group III: Cohort 1: 100µg Experimental Treatment 2 Interventions

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

dAd5GNE Vaccine is already approved in United States for the following indications:

Approved in United States as dAd5GNE Vaccine for:

• Cocaine dependence

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The cocaine vaccine dAd5GNE successfully induced high levels of anti-cocaine antibodies in nonhuman primates, which significantly reduced cocaine's ability to bind to the dopamine transporter (DAT) in the brain.

When anti-cocaine antibody levels were above 4 × 10(5), cocaine occupancy at DAT dropped to less than 20%, well below the threshold needed to produce a 'high', suggesting the vaccine could effectively prevent the effects of cocaine addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adenovirus capsid-based anti-cocaine vaccine prevents cocaine from binding to the nonhuman primate CNS dopamine transporter. Maoz, A., Hicks, MJ., Vallabhjosula, S., et al.[2021]

The dAd5GNE cocaine vaccine was tested in a study with 6 adult female rhesus monkeys, showing that it can significantly delay the reacquisition of cocaine self-administration after a period of abstinence, indicating its potential as a relapse prevention strategy.

While the vaccine did not significantly reduce the overall preference for cocaine over candy in most monkeys, it maintained high serum antibody levels and demonstrated a longer time to resume cocaine use in vaccinated monkeys compared to controls, suggesting a protective effect against relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an adenovirus-based anti-cocaine vaccine to reduce cocaine self-administration and reacqusition using a choice procedure in rhesus macaques. Evans, SM., Foltin, RW., Hicks, MJ., et al.[2018]

The dAd5GNE cocaine vaccine produced long-lasting high levels of anti-cocaine antibodies in rats, effectively reducing cocaine-related behaviors such as hyperlocomotion and self-administration.

Vaccinated rats showed significantly less motivation to seek cocaine and did not exhibit typical relapse behaviors when primed with cocaine, indicating the vaccine's potential to block cocaine-seeking behavior and treat addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel cocaine vaccine linked to a disrupted adenovirus gene transfer vector blocks cocaine psychostimulant and reinforcing effects. Wee, S., Hicks, MJ., De, BP., et al.[2021]

Cocaine addiction is a significant issue, leading to criminal activities, and currently, there are no effective medications to treat it, highlighting the need for innovative solutions.

Vaccines against cocaine are being developed, with one already in clinical trials, showing promise as a potential method to help motivated addicts overcome their addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-cocaine vaccine development. Kinsey, BM., Kosten, TR., Orson, FM.[2021]

The dAd5GNE cocaine vaccine effectively prevents cocaine from entering the central nervous system in models of both daily and binge cocaine use, demonstrating its potential to reduce cocaine-induced hyperactivity and seizures.

A clinical trial has been initiated to further evaluate the safety and efficacy of dAd5GNE in humans, with the expectation that it will help cocaine addicts by blocking the drug's effects even during high-dose use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cocaine vaccine dAd5GNE protects against moderate daily and high-dose "binge" cocaine use. Havlicek, DF., Rosenberg, JB., De, BP., et al.[2021]

The anticocaine vaccine dAd5GNE effectively prevents cocaine from reaching the brain and other sensitive organs by sequestering it in the blood, which could help treat cocaine use disorders.

In studies with nonhuman primates, the vaccine did not show any adverse effects on major organs, indicating a favorable safety profile while limiting cocaine's systemic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fate of systemically administered cocaine in nonhuman primates treated with the dAd5GNE anticocaine vaccine. Hicks, MJ., Kaminsky, SM., De, BP., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Adenovirus capsid-based anti-cocaine vaccine prevents cocaine from binding to the nonhuman primate CNS dopamine transporter. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of an adenovirus-based anti-cocaine vaccine to reduce cocaine self-administration and reacqusition using a choice procedure in rhesus macaques. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Novel cocaine vaccine linked to a disrupted adenovirus gene transfer vector blocks cocaine psychostimulant and reinforcing effects. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Anti-cocaine vaccine development. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cocaine vaccine dAd5GNE protects against moderate daily and high-dose "binge" cocaine use. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Fate of systemically administered cocaine in nonhuman primates treated with the dAd5GNE anticocaine vaccine. [2021]