RECRUITING

Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals

Conditions

Cocaine Dependence cocaine vaccine Cocaine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase I Randomized, Double-blind, Placebo Control Study for an Anti-cocaine Vaccine

Quick Facts

Study Start:2012-06-26

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02455479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 69 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Sandra Hyde

CONTACT

646-962-2672

sah2003@med.cornell.edu

Principal Investigator

Ronald G Crystal, MD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

WCMC Department of Genetic Medicine

New York, New York, 10021

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Ronald G Crystal, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-06-26

Study Completion Date2026-12

Study Record Updates

Study Start Date2012-06-26

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

cocaine vaccine
cocaine dependence
Cocaine

Additional Relevant MeSH Terms

Cocaine Dependence