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NCT00965263 · ClinicalTrials.gov registry record · Phase 2
Therapeutic Cocaine Vaccine: Human Laboratory Study
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00965263 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 15 participants.
The verdict
NCT00965263, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study 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. 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.
Interventions
- BIOLOGICAL Cocaine vaccine (TA-CD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2003-03 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00965263
The ClinicalTrials.gov registry entry for NCT00965263 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cocaine vaccine (TA-CD) is the first listed.
NCT00965263 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00965263 about?
NCT00965263 is a clinical study titled "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 ...
What is the current status of trial NCT00965263?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2003-03. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00965263?
The interventions under investigation include: Cocaine vaccine (TA-CD) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00965263?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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