Disrupted Adenovirus Vaccine for Cocaine Dependence
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Recruiting
Phase 1Interventional Study
Cocaine Dependence
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 69
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Weill Medical College of Cornell University · Other
Who this trial is looking for
This trial is looking for people who are struggling with cocaine dependence. Participants will receive a vaccine aimed at reducing the effects of cocaine on the brain while also being part of a behavioral therapy program.
Are You a Good Fit for This Trial?
Must not be takingAlprazolamZiprasidone
Rules you outSevere substance use disorderSeizure disorderGuillain-Barré SyndromeHistory of attempted homicide
You may be able to join if
I can provide informed consent.
I am between 21 and 69 years old.
I have been diagnosed with a cocaine use disorder.
I have used cocaine in the past 60 days.
I weigh more than 45 kg.
I will use contraception if I can become pregnant.
I have given consent regarding HIV.
You may not be able to join if
I am not in good overall health.
I have a history of severe psychotic disorders.
I have had significant cardiovascular disease.
I am currently taking beta-blockers.
I have a known allergy to soy.
I have evidence of an active infection.
I have a history of attempted suicide.
I am pregnant or nursing.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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Eligibility Criteria
Accrual will be random, with no bias as to gender or racial/ethnic group. Because the accrual process will be random, it is possible that there may be differences in the proportion of males and females, and racial/ethnic groups among the study individuals. All subjects will be concurrently participa…
Accrual will be random, with no bias as to gender or racial/ethnic group. Because the accrual process will be random, it is possible that there may be differences in the proportion of males and females, and racial/ethnic groups among the study individuals. All subjects will be concurrently participating in behavioral therapy programs run by Dr. Beeder's clinical team. Each case will be reviewed with the Eligibility Committee, comprised of three investigators other than the PI, to determine eligibility. The Principal Investigator will not participate in this process.
All subjects must fulfill all inclusion criteria and none of the exclusion criteria in order to participate in this study.
Inclusion Criteria:
1. All subjects should be able to provide informed consent.
2. Must provide HIV informed consent.
3. Males and females, 21- 69 years of age.
4. 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.
6\. Fertile males and females must agree to use adequate forms of contraception for the duration of the entire study.
7\. Body weight \> 45 kg.
Exclusion Criteria:
1. Individuals not deemed in good overall health by the investigator.
2. Diagnosed history of severe psychotic disorders.
3. Abnormal EKG at screening with changes consistent with cardiac disease.
4. History of significant cardiovascular disease, hypertension, prior myocardial infarction and/or cerebrovascular event.
5. Individuals who are currently on beta-blockers.
6. Physical signs or laboratory values suggestive of systemic disorders.
7. History of attempted suicide, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) and/or committed homicide.
8. History of diagnosed obsessive compulsive disorder (OCD).
9. Known allergy to soy.
10. Individuals who are currently taking alprazolam (Xanax) or ziprasidone (Geodon).
11. Evidence of active infection of any types, including COVID-19, or positive for human immunodeficiency virus (HIV).
12. Historical or current use of immunomodulators or immunosuppressants \<5 years prior to screening.
13. Receipt of blood within 3 months of screening.
14. Females who are pregnant or nursing.
15. Concurrent participation in any other FDA approved Investigational New Drug.
16. Abnormal liver function (transaminases greater than 2x the upper limit of normal values)
17. eGFR \<30 mL/min/1.73 m2
18. Severe substance use disorder based on DSM-V-TR criteria (excluding cocaine, nicotine, caffeine, alcohol, marijuana and opiates prescribed for medication assisted therapy or pain treatment) currently not in remission according to one of the following criteria:
* Early Full Remission: This specifier is used if none of the criteria for Dependence or Abuse have been met for at least 1 month, but less than 12 months OR
* 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. OR
* Sustained Full Remission: This specifier is used if none of the criteria for Dependence or Abuse have been met at any time during a period of 12 months or longer OR
* Sustained 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 a period of 12 months or longer OR
* On Agonist Therapy: This specifier is used if the individual is on a prescribed agonist medication, and none of the criteria for Dependence or Abuse has been met for that class of medication for at least the past month (except tolerance to, or withdrawal from, the agonist). This category also applies to those being treated for Dependence using a partial agonist or an agonist/antagonist OR
* Substance Use Related Disorder (mild) up to two disorders: Patients that are assessed to have mild substance-use-related disorders according to the DSM-V criteria will be allowed to participate in the study as long as the number of the disorder-resulting substances does not exceed two (with the exception of the nicotine, caffeine, alcohol, marijuana and opiates prescribed for medication assisted therapy or pain treatment).
19. History of any seizure disorder.
20. Individuals with history of Guillain-Barré Syndrome.
21. Diagnosis of \>2 Substance Use Related Disorders (mild) based on DSM-V- TR criteria (excluding nicotine, caffeine, alcohol, marijuana and opiates prescribed for medication assisted therapy or pain treatment
22. On a prescribed agonist medication, with criteria for dependence or abuse for that class ofmedication for at least the past month (except tolerance to, or withdrawal from, the agonist
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