Multisite Controlled Trial of Cocaine Vaccine (TA-CD)
The purpose of this study is to test the efficacy of a newly developed active vaccine against cocaine (TA-CD).
Drug: TA-CD Vaccination
Other: Placebo Injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- The effect of TA-CD 400 µg compared to placebo on cocaine dependence over 8 weeks (Weeks 9 to 16 inclusive) [ Time Frame: Over 8 weeks ( Study Weeks 9 to 16 inclusive) ] [ Designated as safety issue: Yes ]
- •The immunogenicity of TA-CD; and change in levels of cocaine use and antibody levels;•The safety and tolerability of TA-CD, based on clinician observation, laboratory findings,Etc. [ Time Frame: During the 18 weeks study period. and a follow-up safety visit: week 24 ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: 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).
Other: Placebo Injection
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.
Other Name: An aluminium hydroxide gel adjuvant in a saline solution.
Experimental: 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).
Drug: TA-CD Vaccination
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.
Other Name: A protein conjugate adsorbed onto aluminium hydroxide gel adjuvant in a saline solution.
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.
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21224|
|United States, New York|
|Substance Abuse Treatment and Research Service (Downtown)|
|New York, New York, United States, 10032|
|NYU Langone Medical Center|
|New york, New York, United States, 10010|
|United States, Ohio|
|Cincinnati Addiction Research Center|
|Cincinnati, Ohio, United States, 45220|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas R Kosten, M.D.||Baylor College of Medicine|