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Tests treatment safety and results for Cocaine Dependence
Official title Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
ClinicalTrials.gov ID: NCT02455479
What this study is testing
What is dAd5GNE Vaccine?
dAd5GNE Vaccine is an investigational medicine, being studied as a potential treatment for cocaine dependence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 32 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 69
You may be able to join if
- 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...
- All people must fulfill all and none of the
You likely can't join if
- in order to participate in this study. Inclusion Criteria:
- All people 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...
- Individuals not deemed in good overall health by the investigator.
See the full 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...
- All people must fulfill all and none of the
- in order to participate in this study. Inclusion Criteria:
- All people 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 32 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.