Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: A randomized, double-blind, placebo-controlled efficacy trial

Archives of General Psychiatry

Volumn 66, Issue 10, 2009, Pages 1116-1123

  Martell, Bridget A ^a,b   Orson, Frank M ^c,d   Poling, James ^a,b   Mitchell, Ellen ^a,b   Rossen, Roger D ^c,d   Gardner, Tracie ^c,d   Kosten, Thomas R ^c,d  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

^c BAYLOR COLLEGE OF MEDICINE   (United States)

^d MICHAEL E DEBAKEY VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALCOHOL; CANNABIS; CHOLERA TOXIN B SUBUNIT; COCAINE; IMMUNOGLOBULIN G; METHADONE; OPIATE; PLACEBO; RECOMBINANT PROTEIN; SUCCINYLNOCOCAINE; UNCLASSIFIED DRUG;

ADULT; ALCOHOLIC PANCREATITIS; ARTICLE; CELLULITIS; CLINICAL TRIAL; COCAINE DEPENDENCE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FACIAL CELLULITIS; FEMALE; HEMATURIA; HOT FLUSH; HUMAN; HYPERHIDROSIS; IMMUNOGENICITY; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALE; NAUSEA; RANDOMIZED CONTROLLED TRIAL; RIGHT FOREARM CELLULITIS; SPONTANEOUS ABORTION; TOOTH ABSCESS; TOOTH PAIN; URINALYSIS; VACCINATION; VAGINA BLEEDING;

ADOLESCENT; ADULT; COCAINE-RELATED DISORDERS; DOUBLE-BLIND METHOD; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOGLOBULIN G; IMMUNOTHERAPY, ACTIVE; MALE; METHADONE; MIDDLE AGED; OPIOID-RELATED DISORDERS; SUBSTANCE ABUSE DETECTION; TREATMENT OUTCOME;

EID: 70349690285     PISSN: 0003990X     EISSN: 15383636     Source Type: Journal    
DOI: 10.1001/archgenpsychiatry.2009.128     Document Type: Article

References (51)

1. McLellan AT, Lewis DC, O'Brien CP, Kleber HD. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. JAMA. 2000;284(13):1689-1695.
2. Substance Abuse and Mental Health Services Administration, US Department of Health and Human Services. National estimates of drug-related emergency department visits, 2005. http://dawninfo.samhsa.gov. Accessed September 20, 2008.
3. Substance Abuse and Mental Health Services Administration, US Department of Health and Human Services. Summary of Findings From the 2007 National Household Survey on Drug Abuse. Rockville, MD: Substance Abuse & Mental Health Services Administration, US Dept of Health & Human Services; 2008.
4. de Lima MS, de Oliveira Soares BG, Reisser AA, Farrell M. Pharmacological treatment of cocaine dependence: a systematic review. Addiction. 2002;97(8):931-949. (Pubitemid 34888476)
5. Vocci FJ Jr, Elkashef A. Pharmacotherapy and other treatments for cocaine abuse and dependence. Curr Opin Psychiatry. 2005;18(3):265-270. (Pubitemid 40586109)
6. Lima MS, Reisser AA, Soares BG, Farrell M. Antidepressants for cocaine dependence [update of: Cochrane Database Syst Rev. 2001;(4):CD002950]. Cochrane Database Syst Rev. 2003;(2):CD002950.
7. Knapp WP, Soares BG, Farrel M, Lima MS. Psychosocial interventions for cocaine and psychostimulant amphetamines related disorders. Cochrane Database Syst Rev. 2007;(3):CD003023. (Pubitemid 351805624)
8. Carroll KM, Fenton LR, Ball SA, Nich C, Frankforter TL, Shi J, Rounsaville BJ. Efficacy of disulfiram and cognitive behavior therapy in cocaine-dependent outpatients: a randomized placebo-controlled trial. Arch Gen Psychiatry. 2004;61(3):264-272. (Pubitemid 38295828)
9. Dutra L, Stathopoulou G, Basden SL, Leyro TM, Powers MB, Otto MW. A meta-analytic review of psychosocial interventions for substance use disorders. Am J Psychiatry. 2008;165(2):179-187. (Pubitemid 351704516)
10. Silverman K, Chutuape MA, Bigelow GE, Stitzer ML. Voucher-based reinforcement of cocaine abstinence in treatment-resistant methadone patients: effects of reinforcement magnitude. Psychopharmacology (Berl). 1999;146(2):128-138. (Pubitemid 29474204)
11. Fox BS, Kantak KM, Edwards MA, Black KM, Bollinger BK, Botka AJ, French TL, Thompson TL, Schad VC, Greenstein JL, Gefter ML, Exley MA, Swain PA, Briner TJ. Efficacy of a therapeutic cocaine vaccine in rodent models. Nat Med. 1996;2(10):1129-1132. (Pubitemid 26338633)
12. Fox BS. Development of a therapeutic vaccine for the treatment of cocaine addiction. Drug Alcohol Depend. 1997;48(3):153-158. (Pubitemid 27526021)
13. Carrera MR, Ashley JA, Parsons LH, Wirsching P, Koob GF, Janda KD. Suppression of psychoactive effects of cocaine by active immunization. Nature. 1995;378(6558):727-730. (Pubitemid 26001945)
14. Norman AB, Tabet MR, Norman MK, Buesing WR, Pesce AJ, Ball WJ. A chimeric human/murine anticocaine monoclonal antibody inhibits the distribution of cocaine to the brain in mice. J Pharmacol Exp Ther. 2007;320(1):145-153.
15. Lynch TJ, Mattes CE, Singh A, Bradley RM, Brady RO, Dretchen KL. Cocaine detoxification by human plasma butyrylcholinesterase. Toxicol Appl Pharmacol. 1997;145(2):363-371. (Pubitemid 27346526)
16. Nutt DJ. Addiction: brain mechanisms and their treatment implications. Lancet. 1996;347(8993):31-36. (Pubitemid 26012416)
17. Oldendorf WH. Some relationships between addiction and drug delivery to the brain. NIDA Res Monogr. 1992;120:13-25. (Pubitemid 23095632)
18. Haney M, Kosten TR. Therapeutic vaccines for substance dependence. Expert Rev Vaccines. 2004;3(1):11-18.
19. 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(2):130-132.
20. Jertborn M, Svennerholm AM, Holmgren J. Immunological memory after immunization with oral cholera B subunit - whole-cell vaccine in Swedish volunteers. Vaccine. 1994;12(12):1078-1082. (Pubitemid 2123410)
21. Holmgren J, Czerkinsky C, Lycke N, Svennerholm AM. 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(5)(suppl):42-54. (Pubitemid 24208667)
22. Svennerholm AM, Gothefors L, Sack DA, Bardhan PK, Holmgren J. Local and systemic antibody responses and immunological memory in humans after immunization with cholera B subunit by different routes. Bull World Health Organ. 1984;62(6):909-918. (Pubitemid 15138813)
23. Kosten TR, Rosen M, Bond J, Settles M, Roberts JS, Shields J, Jack L, Fox B. Human therapeutic cocaine vaccine: safety and immunogenicity. Vaccine. 2002;20(7-8):1196-1204. (Pubitemid 34135957)
24. Martell BA, Mitchell E, Poling J, Gonsai K, Kosten TR. Vaccine pharmacotherapy for the treatment of cocaine dependence. Biol Psychiatry. 2005;58(2):158-164. (Pubitemid 41008133)
25. Jenkins AJ, Keenan RM, Henningfield JE, Cone EJ. Correlation between pharmacological effects and plasma cocaine concentrations after smoked administration. J Anal Toxicol. 2002;26(7):382-392.
26. Orson FM, Kinsey BM, Singh RA, Wu Y, Gardner T, Kosten TR. The future of vaccines in the management of addictive disorders. Curr Psychiatry Rep. 2007;9(5):381-387. (Pubitemid 47559359)
27. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 1994.
28. Ball JC, Corty E, Petroski SP, Bond H, Tommasello A, Graff H. Treatment effectiveness: medical staff and services provided to 2394 patients at methadone programs in three states. NIDA Res Monogr. 1987;76:175-181. (Pubitemid 17167611)
29. Treatment Improvement Protocol (TIP) Series 43 Consensus Panel. Clinical pharmacotherapy. In: Batki SL, Kauffman JF, Marion I, Parrino MW, Woody GE, eds; Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs. Rockville, MD: Substance Abuse & Mental Health Services Administration, US Dept of Health & Human Services; 2005:63-85.
30. Mallinckrodt Pharmaceuticals. Mallinckrodt Pharmaceuticals addiction treatment products. http://pharmaceuticals.mallinckrodt.com/Products/ ProductList.asp?UT=0&BusinessUnitID=4. Accessed July 2, 2009.
31. Treatment Improvement Protocol (TIP) Series 33 Consensus Panel. TIP 33: Treatment for Stimulant Use Disorders. Rockville, MD: Center for Substance Abuse Treatment, Substance Abuse & Mental Health Services Administration, US Dept of Health & Human Services; 1999. http://www.ncbi.nlm.nih.gov/books/bv. fcgi?rid=hstat5.chapter.57310. Accessed September 20, 2008.
32. Golm GT, Halloran ME, Longini IMJ Jr. Semi-parametric models for mismeasured exposure information in vaccine trials. Stat Med. 1998;17(20):2335-2352.
33. Halloran ME, Longini IMJ Jr. Using validation sets for outcomes and exposure to infection in vaccine field studies. Am J Epidemiol. 2001;154(5):391-398.
34. Paula S, Tabet MR, Farr CD, Norman AB, Ball WJJ Jr. Three-dimensional quantitative structure-activity relationship modeling of cocaine binding by a novel human monoclonal antibody. J Med Chem. 2004;47(1):133-142. (Pubitemid 38040497)
35. Preston KL, Silverman K, Schuster CR, Cone EJ. Assessment of cocaine use with quantitative urinalysis and estimation of new uses. Addiction. 1997;92(6):717-727. (Pubitemid 27267801)
36. Gibbons RD, Hedeker D, Elkin I, Waternaux C, Kraemer HC, Greenhouse JB, Shea MT, Imber SD, Sotsky SM, Watkins JT. Some conceptual and statistical issues in analysis of longitudinal psychiatric data: application to the NIMH Treatment of Depression Collaborative Research Program dataset. Arch Gen Psychiatry. 1993;50(9):739-750. (Pubitemid 23263811)
37. Bryk AS, Raudenbush SW. Application of hierarchical linear models to assessing change. Psychol Bull. 1987;101(1):147-158.
38. Oliveto AH, Feingold A, Schottenfeld R, Jatlow P, Kosten TR. Desipramine in opioid-dependent cocaine abusers maintained on buprenorphine vs methadone. Arch Gen Psychiatry. 1999;56(9):812-820. (Pubitemid 29420702)
39. Schottenfeld RS, Pakes JR, Oliveto A, Ziedonis D, Kosten TR. Buprenorphine vs methadone maintenance treatment for concurrent opioid dependence and cocaine abuse. Arch Gen Psychiatry. 1997;54(8):713-720. (Pubitemid 27344098)
40. Kosten T, Oliveto A, Feingold A, Poling J, Sevarino K, McCance-Katz E, Stine S, Gonzalez G, Gonsai K. Desipramine and contingency management for cocaine and opiate dependence in buprenorphine maintained patients. Drug Alcohol Depend. 2003;70(3):315-325. (Pubitemid 36577343)
41. Poling J, Oliveto A, Petry NM, Sofuoglu M, Gonsai K, Gonzalez G, Martell B, Kosten TR. Six-month trial of bupropion with contingency management for cocaine dependence in a methadone-maintained population. Arch Gen Psychiatry. 2006;63(2):219-228. (Pubitemid 43213884)
42. McLachlan C, Crofts N, Wodak A, Crowe S. The effects of methadone on immune function among injection drug users: a review. Addiction. 1993;88(2):257-263. (Pubitemid 23089838)
43. De Waal EJ, Van der Laan JW, Van Loveren H. Effects of prolonged exposure to morphine and methadone on in vivo parameters of immune function in rats. Toxicology. 1998;129(2-3):201-210. (Pubitemid 29023148)
44. Ghitza UE, Epstein DH, Preston KL. Psychosocial functioning and cocaine use during treatment: strength of relationship depends on type of urine-testing method. Drug Alcohol Depend. 2007;91(2-3):169-177.
45. Haney M, Gunderson EW, Collins ED, Foltin RW. Cocaine vaccine: smoked cocaine administration in humans. Paper presented at: College on Problems in Drug Dependence; June 20, 2006; Scottsdale, AZ.
46. Boyd B. NicVAX (TM): aid to smoking cessation, nicotine vaccine. Drugs Future. 2006;31(3):203-205. (Pubitemid 43759271)
47. Svensson TH. Active immunization against nicotine for smoking cessation and relapse prevention. Int J Neuropsychopharmacol. 2006;9(suppl):S55.
48. Hatsukami DK, Rennard S, Jorenby D, Fiore M, Koopmeiners J, de Vos A, Horwith G, Pentel PR. Safety and immunogenicity of a nicotine conjugate vaccine in current smokers [published correction appears in Clin Pharmacol Ther. 2006 Apr;79(4):396]. Clin Pharmacol Ther. 2005;78(5):456-467.
49. Cornuz J, Klingler K, Mueller P, Jungi F, Cerny T. A therapeutic vaccine for nicotine dependence: results of a phase I and a randomized phase II study. J Clin Oncol. 2005;23(16)(suppl):1008.
50. Tissot AC, Maurer P, Nussberger J, Sabat R, Pfister T, Ignatenko S, Volk HD, Stocker H, Müller P, Jennings GT, Wagner F, Bachmann MF. Effect of immunisation against angiotensin II with CYT006-AngQb on ambulatory blood pressure: a double-blind, randomised, placebo-controlled phase IIa study. Lancet. 2008;371(9615):821-827. (Pubitemid 351323893)
51. Kosten TR, Kleber HD. Strategies to improve compliance with narcotic antagonists. Am J Drug Alcohol Abuse. 1984;10(2):249-266.