Is NCT02455479 recruiting in New York, NY?

Yes, NCT02455479 is currently recruiting participants at its New York, NY location. This cocaine dependence clinical trial is actively enrolling qualified participants.

How do I join the cocaine dependence clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cocaine Dependence Clinical Trial in New York, NY

About This Cocaine Dependence Study in New York

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.

Sponsor: Weill Medical College of Cornell University

Who Can Participate

Inclusion Criteria

and none of the

Exclusion Criteria

in order to participate in this study. Inclusion Criteria:

All subjects should be able to provide informed consent.

Must provide HIV informed consent.

Males and females, 21- 69 years of age.

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:

Individuals not deemed in good overall health by the investigator.

Diagnosed history of severe psychotic disorders.

Abnormal EKG at screening with changes consistent with cardiac disease.

History of significant cardiovascular disease, hypertension, prior myocardial infarction and/or cerebrovascular event.

Individuals who are currently on beta-blockers.

Physical signs or laboratory values suggestive of systemic disorders.

History of attempted suicide, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) and/or committed homicide.

History of diagnosed obsessive compulsive disorder (OCD).

Known allergy to soy.

Individuals who are currently taking alprazolam (Xanax) or ziprasidone (Geodon).

Evidence of active infection of any types, including COVID-19, or positive for human immunodeficiency virus (HIV).

Historical or current use of immunomodulators or immunosuppressants \<5 years prior to screening.

Receipt of blood within 3 months of screening.

Females who are pregnant or nursing.

Concurrent participation in any other FDA approved Investigational New Drug.

Abnormal liver function (transaminases greater than 2x the upper limit of normal values)

eGFR \<30 mL/min/1.73 m2

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).

History of any seizure disorder.

Individuals with history of Guillain-Barré Syndrome.

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT02455479) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cocaine Dependence Treatment Options in New York, NY

If you're searching for cocaine dependence treatment options in New York, NY, this clinical trial (NCT02455479) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced cocaine dependence specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cocaine dependence clinical trials near you to find additional studies recruiting in your area.

Cocaine Dependence Clinical Trial in New York, NY

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