Vaccine for cocaine dependence: A randomized double-blind placebo-controlled efficacy trial

Drug and Alcohol Dependence

Volumn 140, Issue , 2014, Pages 42-47

  Kosten, Thomas R ^a   Domingo, Coreen B ^a   Shorter, Daryl ^a   Orson, Frank ^a   Green, Charles ^b   Somoza, Eugene ^c   Sekerka, Rachelle ^c   Levin, Frances R ^d   Mariani, John J ^d   Stitzer, Maxine ^e   Tompkins, D Andrew ^e   Rotrosen, John ^f   Thakkar, Vatsal ^f   Smoak, Benjamin ^f   Kampman, Kyle ^g  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF TEXAS   (United States)

^c UNIVERSITY OF CINCINNATI   (United States)

^d Och Spine at New York Presbyterian Hospitals   (United States)

^e JOHNS HOPKINS UNIVERSITY   (United States)

^f NEW YORK UNIVERSITY   (United States)

^g UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Clinical trial; Cocaine; Immunotherapy; Vaccine

Indexed keywords

COCAINE; DRUGS USED IN THE TREATMENT OF ADDICTION; IMMUNOGLOBULIN G ANTIBODY; PLACEBO; SUCCINYLNORCOCAINE CHOLERA TOXIN B CONJUGATE; UNCLASSIFIED DRUG; VACCINE; ANTIBODY;

ADULT; ALCOHOL INTOXICATION; ARTICLE; BREAST DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; COCAINE DEPENDENCE; COGNITIVE THERAPY; CONTROLLED STUDY; DEPRESSION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EAR DISEASE; ERECTILE DYSFUNCTION; EYE DISEASE; FEMALE; GASTROINTESTINAL DISEASE; HEART DISEASE; HEMATOLOGIC DISEASE; HUMAN; IMMUNOGENICITY; IMMUNOPATHOLOGY; INFECTION; INJECTION SITE INDURATION; INJECTION SITE REACTION; KIDNEY DISEASE; LEG ULCER; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MIDDLE AGED; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NEOPLASM; NEUROLOGIC DISEASE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SKIN DISEASE; SUICIDAL BEHAVIOR; URINARY TRACT DISEASE; UROGENITAL TRACT DISEASE; VACCINATION; VASCULAR DISEASE; ADOLESCENT; COCAINE-RELATED DISORDERS; ETHNIC GROUP; IMMUNOLOGY; IMMUNOTHERAPY; PROCEDURES; SAFETY; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES; COCAINE; COCAINE-RELATED DISORDERS; DOUBLE-BLIND METHOD; ETHNIC GROUPS; FEMALE; HUMANS; IMMUNOTHERAPY; MALE; MIDDLE AGED; SAFETY; TREATMENT OUTCOME; VACCINATION; VACCINES; YOUNG ADULT;

EID: 84924840368     PISSN: 03768716     EISSN: 18790046     Source Type: Journal    
DOI: 10.1016/j.drugalcdep.2014.04.003     Document Type: Article

References (21)

1. American Psychiatric Association DSM-IV. Diagnostic and Statistical Manual of Mental Disorders 1994, American Psychiatric Association, Washington, DC. fourth ed.
2. Carroll M.E., Zlebnik N.E., Anke r J.J., Kosten T.R., Orson F.M., Shen X., Kinsey B., Parks R.J., Gao Y., Brimijoin S. Combined cocaine hydrolase gene transfer and anti-cocaine vaccine synergistically block cocaine-induced locomotion. PLoS One 2014, (in press).
3. Fox B.S. Development of a therapeutic vaccine for the treatment of cocaine addiction. Drug Alcohol Depend. 1997, 48:153-158.
4. Fox B.S., Kantak K.M., Edwards M.A. Efficacy of a therapeutic cocaine vaccine in rodent models. Nat. Med. 1996, 2:1129-1132.
5. Gao Y., Brimijoin S. An engineered cocaine hydrolase blunts and reverses cardiovascular responses to cocaine in rats. J. Pharmacol. Exp. Ther. 2004, 310:1046-1052.
6. Gao Y., Orson F.M., Kinsey B., Kosten T., Brimijoin S. The concept of pharmacologic cocaine interception as a treatment for drug abuse. Chem. Biol. Interact. 2010, 187:421-424.
7. Haney M., Gunderson E.W., Jiang H., Collins E.D., Foltin R.W. Cocaine-specific antibodies blunt the subjective effects of smoked cocaine in humans 2010, 67:59-65. 10.1016/j.biopsych.2009.08.031.
8. Holmgren J., Czerkinsky C., Lycke N., Svennerholm A.M. Strategies for the induction of immune responses at mucosal surfaces making use of cholera toxin B subunit as immunogen, carrier, and adjuvant. Am. J. Trop. Med. Hyg. 1994, 50:42-54.
9. Jenkins A.J., Keenan R.M., Henningfield J.E., Cone E.J. Correlation between pharmacological effects and plasma cocaine concentrations after smoked administration. J. Anal. Toxicol. 2002, 26:382-392.
10. Jertborn M., Svennerholm A.-M., Holmgren J. Safety and immunogenicity of an oral recombinant cholera B subunit-whole cell vaccine in Swedish volunteers. Vaccine 1992, 10:130-132.
11. Jertborn M., Svennerholm A.M., Holmgren J. Immunological memory after immunization with oral cholera B subunit-whole-cell vaccine in Swedish volunteers. Vaccine 1994, 12:1078-1082.
12. Kosten T.R., Rosen M., Bond J., Settles M., Roberts J.S., Shields J., Jack L., Fox B. Human therapeutic cocaine vaccine: safety and immunogenicity. Vaccine 2002, 20:1196-1204.
13. Martell B., Mitchell E., Poling J., Gonsai K., Kosten T.R. Vaccine pharmacotherapy for the treatment of cocaine dependence. Biol. Psychiatry 2005, 58:158-164.
14. Martell B.A., Orson F.M., Poling J., Mitchell E., Rossen R.D., Gardner T., Kosten T.R. Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial. Arch. Gen. Psychiatry 2009, 66:1116-1123. PMID: 19805702. 10.1001/archgenpsychiatry.2009.128.
15. Norman A.B., Tabet M.R., Norman M.K., Buesing W.R., Pesce A.J., Ball W.J. A chimeric human/murine anti-cocaine monoclonal antibody inhibits the distribution of cocaine to the brain in mice. J. Pharmacol. Exp. Ther. 2007, 320:145-153.
16. Orson F.M., Kinsey B.M., Singh R.A.K., Wu Y., Gardner T., Kosten T.R. The future of vaccines in the management of addictive disorders. Curr. Psychiatry Rep. 2007, 9:381-387.
17. Paula S., Tabet M.R., Farr C.D., Norman A.B., Ball W.J.J. Three-dimensional quantitative structure-activity relationship modeling of cocaine binding by a novel human monoclonal antibody. J. Med. Chem. 2004, 47:133-142.
18. SAMHSA Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings 2012, Substance Abuse and Mental Health Services Administration, Rockville, MD.
19. SAMHSA Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits 2013, Substance Abuse and Mental Health Services Administration, Rockville, MD.
20. SAMHSA Treatment Improvement Protocol 33: Treatment for Stimulant Use Disorders 2010, http://kap.samhsa.gov/products/manuals/index.htm., http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat5.section.57658 accessed January, 2014.
21. Svennerholm A., Gothefors L., Sack D., Bardhan P., Holmgren J. Local and systemic antibody responses and immunological memory after immunization with cholera B subunit by different routes. Bull. WHO 1984, 62:909-918.