Therapeutic Cocaine Vaccine for Cocaine Dependent Individuals
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Effect of Therapeutic Cocaine Vaccine on Cocaine Brain Distribution Measured With Positron Emission Tomography|
|Study Start Date:||September 2003|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218088
|United States, New York|
|Columbia Presbyterian Hospital|
|New York, New York, United States, 10032|
|Brookhaven National Lab|
|Upton, New York, United States, 11973|
|Principal Investigator:||Thomas R. Kosten, MD||American Academy of Addiction Psychiatry|