Multisite Controlled Trial of Cocaine Vaccine

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Other: Placebo Injection; Drug: TA-CD Vaccination

• Registration Number: NCT00969878
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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

Detailed Description

This 18-week, placebo-controlled randomized clinical trial among 300 cocaine dependent patients is designed to test the efficacy of a newly developed active vaccine against cocaine (TA-CD). TA-CD vaccine consists of succinylnorcocaine (SNC) coupled to a recombinant cholera toxin B subunit (rCTB) and is designed to raise anti-cocaine antibodies in the circulation to bind to cocaine entering the bloodstream, following administration by intravenous or intranasal routes or by smoking. The antigen-antibody complexes will be too large to cross the blood-brain barrier, preventing high concentrations of cocaine reaching the brain's nucleus accumbens thereby blocking the pleasurable response to cocaine and reducing rates of drug use. The effectiveness of the vaccine is dependent on inducing sufficient levels of anti-cocaine antibodies to match the challenge from a subsequent dose of cocaine.

Because TA-CD takes several weeks to generate an antibody response, we plan to use contingency management in this interval to sustain treatment engagement. Furthermore, since TA-CD may prove most effective in patients where the antibodies can prevent a cocaine slip from turning into a binge (or return to regular use) by attenuating the priming effect, we are complementing the vaccine by using cognitive behavioral therapy (CBT) to teach patients how to cope with this priming effect and prevent a full relapse.

Study Timeline

• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Study Start: 2010-08
• Primary Completion: 2012-08
• Study Completion: 2014-07
• Results First Submitted: 2014-07-17
• Results First Submitted QC: 2014-12-11
• Results First Posted: 2014-12-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-04
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo injection	Placebo Injection	TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).
TA-CD Vaccination	TA-CD Vaccination	TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).

Primary Outcome Measures

Name	Time	Method
Cocaine Abstinence During Weeks 9 to 16 Inclusive	Over 8 weeks ( Study Weeks 9 to 16 inclusive)	Number of patients having at least 2 weeks of cocaine-free urines between weeks 9-16 after vaccination with five doses of TA-CD 400 µg compared to placebo

Secondary Outcome Measures

Name	Time	Method
•The Immunogenicity of TA-CD;	During the 18 weeks study period.	Peak antibody levels after five vaccinations with TA-CD, which occurred at week 16.

Trial Locations

Locations (6)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Substance Abuse Treatment and Research Service (Downtown); 🇺🇸 New York, New York, United States

Cincinnati Addiction Research Center; 🇺🇸 Cincinnati, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

NYU Langone Medical Center; 🇺🇸 New york, New York, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States