This 16 week, six site, placebo-controlled randomized, clinical trial (PC-RCT) among 300 cocaine dependent patients is designed to test the efficacy of a newly developed active vaccine against cocaine (TA-CD). All six sites have substantial NIDA experience in conducting PC-RCT with cocaine pharmacotherapies. The primary objective of this study is to evaluate the efficacy of two different doses of TA-CD (100 or 400 ug) versus placebo to increase the number of cocaine-free days across treatment groups in cocaine-dependent patients. Secondary objectives of this study are: to evaluate safety and tolerability of five injections of TA-CD, to evaluate immunogenicity of TA-CD, to investigate any correlation between change in levels of cocaine use, craving, or subjective effects of cocaine and antibody levels, and finally, to examine predictors of treatment response. Previous work with the TA-CD vaccine has shown both doses (100 and 400 ug) and a regimen of 5 injections over 12 weeks are clinically safe and produce substantial levels of anti-cocaine antibody. During a previous PC-RCT, cocaine abusers with these anti-cocaine antibodies (AB) substantially reduced their smoked cocaine and had a significant reduction in overall cocaine use. That study also showed an expected variation in AB levels was a determinant of therapeutic response (e.g. higher AB levels were associated with a greater reduction in cocaine use). That previous PC-RCT provided effect size data for calculating the sample size of 300 with a potential dropout of up to 30%. In order to enhance retention in this 16-week study, we will use contingency management (CM), which in a pilot study provided outstanding retention of over 80% for a 16 week study. To complete this study within a 3 year period and have reasonable accrual and retention of this difficult population requires participation of six sites. These six extremely well-qualified research groups have comparable and complementary skills that can examine innovative ways to deliver a medical therapy through vaccination. The six sites are: Baylor College of Medicine (BCM), (lead);University of Cincinnati;Johns Hopkins University;University of Pennsylvania;New York University;and, Columbia University. All of these collaborators are working with the pharmaceutical manufacturer--Celtic, and NIDA to help with data management and laboratory-processing for quantitative urine toxicology.

Public Health Relevance

New approaches are needed to help treat those addicted to cocaine to successfully keep from relapsing to drug abuse after withdrawal. Vaccines that stimulate strong antibody responses against cocaine will help such individuals by blocking the drug craving that occurs after re-exposure to cocaine in someone who has been abstinent. This research will define ways to make and effectively use such vaccines to stimulate high antibody levels that will have the best chance of success.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Research Project (R01)
Project #
Application #
Study Section
Special Emphasis Panel (ZDA1-KXN-G (14))
Program Officer
Biswas, Jamie
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Baylor College of Medicine
Schools of Medicine
United States
Zip Code
Kosten, Thomas R; Domingo, Coreen B; Shorter, Daryl et al. (2014) Vaccine for cocaine dependence: a randomized double-blind placebo-controlled efficacy trial. Drug Alcohol Depend 140:42-7
Orson, Frank M; Wang, Rongfu; Brimijoin, Stephen et al. (2014) The future potential for cocaine vaccines. Expert Opin Biol Ther 14:1271-83
Oliveto, Alison; Poling, James; Mancino, Michael J et al. (2012) Sertraline delays relapse in recently abstinent cocaine-dependent patients with depressive symptoms. Addiction 107:131-41
Sorensen, James L; Kosten, Thomas (2011) Developing the tools of implementation science in substance use disorders treatment: applications of the consolidated framework for implementation research. Psychol Addict Behav 25:262-8
Mancino, Michael J; Gentry, Brooks W; Feldman, Zachary et al. (2011) Characterizing methamphetamine withdrawal in recently abstinent methamphetamine users: a pilot field study. Am J Drug Alcohol Abuse 37:131-6
Kinsey, Berma M; Kosten, Thomas R; Orson, Frank M (2010) Anti-cocaine vaccine development. Expert Rev Vaccines 9:1109-14
Cosgrove, Kelly P; Tellez-Jacques, Karen; Pittman, Brian et al. (2010) Dopamine and serotonin transporter availability in chronic heroin users: a [¹²³I]?-CIT SPECT imaging study. Psychiatry Res 184:192-5
Kinsey, Berma M; Kosten, Thomas R; Orson, Frank M (2010) Active immunotherapy for the Treatment of Cocaine Dependence. Drugs Future 35:301-306
Martell, Bridget A; Orson, Frank M; Poling, James et al. (2009) Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial. Arch Gen Psychiatry 66:1116-23
Stotts, Angela L; Dodrill, Carrie L; Kosten, Thomas R (2009) Opioid dependence treatment: options in pharmacotherapy. Expert Opin Pharmacother 10:1727-40

Showing the most recent 10 out of 11 publications