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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: Completed Phase 2 study, sponsored by New York State Psychiatric Institute.
NCT00965263 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Visual Analogue Scale ratings (0-100mm) of the Good Drug Effect cluster ("Good Drug Effect," "High," "Stimulated") over 13 weeks as a function of cocaine dose (25mg or 50mg). Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate more agreement with the statements.
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 |
What the finished NCT00965263 record still lists
NCT00965263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Cocaine vaccine (TA-CD) is the first listed.
NCT00965263 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00965263's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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