Therapeutic Cocaine Vaccine for Cocaine Dependent Individuals

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218088
First received: September 16, 2005
Last updated: March 12, 2008
Last verified: March 2008
  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 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Columbia Presbyterian Hospital
New York, New York, United States, 10032
Brookhaven National Lab
Upton, New York, United States, 11973
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas R. Kosten, MD American Academy of Addiction Psychiatry
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on July 24, 2014