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Therapeutic Cocaine Vaccine for Cocaine Dependent Individuals

This study has been completed.

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218088
  Purpose

Cocaine addiction is a chronic disorder for which there is not yet an effective drug treatment. A vaccine against cocaine would create cocaine-specific antibodies that would act to immunize cocaine addicts against the effects of cocaine. With this type of vaccine, the behavioral effects of cocaine use would be minimized, thereby reducing the chance of addiction relapse. This study will use positron emission tomography (PET) to measure the changes of cocaine distribution within the brain and body following anti-cocaine vaccination.


Condition Phase
Cocaine-Related Disorders
Phase II

Drug Information available for:   8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))-    Cocaine hydrochloride   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Effect of Therapeutic Cocaine Vaccine on Cocaine Brain Distribution Measured With Positron Emission Tomography

Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment:   10
Study Start Date:   September 2003
Study Completion Date:   September 2006
Primary Completion Date:   September 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Treating cocaine abuse is difficult because cocaine causes physical and behavioral changes in the body that reinforce the addicts' need for the drug. As a result, the rate of relapse of cocaine abuse is very high. A vaccine against cocaine would create cocaine-specific antibodies. The antibodies would work to immunize addicts against the effects of cocaine by reducing the drug's concentration in the brain. This study will use PET to measure the changes of cocaine distribution within the brain and body following anti-cocaine vaccination.

Participants in this study will be assigned to one of two groups for a total of 12 weeks. Group A participants will be recruited from a concurrent study, in which a cocaine vaccine will be administered. Group B participants will not receive the cocaine vaccine. Baseline assessments, including two PET scans, will be performed for both groups during an inpatient phase. The first PET scan will follow an injection of a cocaine tracer dose. The second PET scan will follow injection of a cocaine tracer dose combined with a low dose of cocaine. Both scans will assess the extent of infiltration of cocaine in the body. The cocaine vaccine will then be administered to Group A. Members of Group B will return to the study site weekly during the 11 weeks between scans to assess general health and well-being. Each visit will last 15 to 30 minutes. PET scans will be performed again at Week 12 for both groups. Follow-up visits will be held for both groups between 1 and 7 days following each scanning day. At this time, participants will receive a medical exam, a psychiatric assessment, blood tests, and an electrocardiogram.

  Eligibility
Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Meets DSM-IV criteria for current cocaine dependence
  • Primary route of cocaine intake is smoking

Exclusion Criteria:

  • Current DSM-IV Axis I disorder other than cocaine abuse or dependence
  • Currently meets DSM-IV criteria for dependence on substances other than cocaine or nicotine
  • Currently taking psycotropic medications (e.g., antidepressants, antipsychotics)
  • History of or current bipolar disorder or other psycotic disorder
  • History of or current severe medical or neurological illness, including ongoing active infection
  • Resting systolic blood pressure greater than 150 mm Hg and a diastolic blood pressure greater than 90 mm Hg
  • Current abnormal thyroid indices
  • Current heart abnormality
  • Current pseudocholinesterase deficiency
  • Currently seeking treatment for cocaine dependence
  • History of psychosis as a resut of substance abuse
  • History of exposure to radiation in the workplace
  • History of a nuclear medicine procedure in the year prior to study entry (the following criteria will allow eligibility: participation in a protocol from the Division of Functional Brain Mapping with a known injected dose and dosimetry of the radiotracer; no lifetime exposure to radiation, aside from participation in research studies; a yearly cumulative exposure lower than the limit defined by the FDA for reserach study participants upon adding any previous exposure to the exposure from this study)

Additional Exclusion Criteria for Participants in Group A:

  • History of autoimmune disease, immune deficiency, or hypersensitivity to vaccines
  • Postive HIV test
  • Recipient of a blood transfusion or recipient of blood products within 3 months prior to vaccination
  • Has been vaccinated within 30 days of participation in the study (includes flu vaccine)
  • Currently taking immunosuppressive drugs
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218088

Locations
United States, New York
Brookhaven National Lab    
      Upton, New York, United States, 11973
Columbia Presbyterian Hospital    
      New York, New York, United States, 10032

Sponsors and Collaborators

Investigators
Principal Investigator:     Thomas R. Kosten, MD     American Academy of Addiction Psychiatry    
  More Information


Responsible Party:   Baylor College of Medicine ( Thomas Kosten, MD )
Study ID Numbers:   NIDA-10946-1, U19-10946-1, DPMC
First Received:   September 16, 2005
Last Updated:   March 12, 2008
ClinicalTrials.gov Identifier:   NCT00218088
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Cocaine-Related Disorders
Dopamine
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 31, 2008




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