CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Cocaine vaccine (TA-CD)biological
Likely dose
Cocaine vaccine (TA-CD) 82,360 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00965263
NCT00965263Phase 2Completed
CompareCT.gov

Tests of a Therapeutic Cocaine Vaccine

New York State Psychiatric Institute·interventional·Posted Aug 25, 2009·Updated Dec 11, 2017

In Brief

A Phase 2 clinical trial evaluating Cocaine vaccine (TA-CD) for Cocaine Dependence. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 25, 2009
Enrollment StartMar 1, 2003
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 16.9 years ago

Interventions

Cocaine vaccine (TA-CD)biological

TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.