CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 300 enrolled
Drug / intervention
TA-CD Vaccination +1 moredrug
Likely dose
Not stated in 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/NCT00969878
NCT00969878Phase 2Completed
CompareCT.gov

A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Assess the Clinical Efficacy, Safety, and Immunogenicity of a Human Cocaine Vaccine (TA-CD) in the Treatment of Cocaine Dependence

Baylor College of Medicine·interventional·Posted Sep 1, 2009·Updated Mar 15, 2017

In Brief

A Phase 2 clinical trial evaluating TA-CD Vaccination and Placebo Injection for Cocaine Dependence. Completed, enrolled 300 participants across 6 sites.

Detailed Summary

The purpose of this study is to test the efficacy of a newly developed active vaccine against cocaine (TA-CD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), US Department of Veterans Affairs Cooperative Studies Program, VA Maryland Health Care System, Columbia University, VA New York Harbor Healthcare System, University of Pennsylvania, Johns Hopkins University, University of Cincinnati, Celtic Pharma Development Services

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2009
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2012
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.8 years ago

Interventions

TA-CD Vaccinationdrug

On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor.

Placebo Injectionother

On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor.