Therapeutic Cocaine Vaccine: Human Laboratory Study
Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. The objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects.
Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Tests of a Therapeutic Cocaine Vaccine|
- Cocaine intoxication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Cocaine cardiovascular effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2003|
|Study Completion Date:||August 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
All subjects received 4 active vaccinations with TA-CD
TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965263
|United States, New York|
|New York-Presbyterian Hospital|
|New York, New York, United States, 10032|
|Principal Investigator:||Margaret Haney, Ph.D.||Columbia University|