Status:
COMPLETED
Therapeutic Cocaine Vaccine: Human Laboratory Study
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Cocaine Dependence
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief Summary
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. T...
Detailed Description
I do not desire to provide a more extensive description.
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine).
- Primary route of cocaine administration is smoking.
- Age 21-45.
- Females must be surgically sterilized or post- menopausal
- Able to give informed consent, and comply with study procedures.
Exclusion
- Dependence on substances other than cocaine or nicotine.
- Judged to be noncompliant with study protocol.
- History of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. An HIV test must be negative.
- Currently uses drugs intravenously
- Currently taking any psychotropic medication
- Laboratory tests that are clinically unacceptable to the study physician (BP \> 140/90; BUN, creatinine, LFTs \> 1.5 ULN; hematocrit \< 34 for women, \< 36 for men)
- Blood or blood products given in the three months prior to vaccination
- Other vaccines, including flu vaccine, given within 30 days of screening.
- Ongoing active infection
- Currently taking immunosuppressives -
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00965263
Start Date
March 1 2003
End Date
August 1 2009
Last Update
December 11 2017
Active Locations (1)
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1
New York-Presbyterian Hospital
New York, New York, United States, 10032