The safety of disulfiram for the treatment of alcohol and cocaine dependence in randomized clinical trials: Guidance for clinical practice

Expert Opinion on Drug Safety

Volumn 7, Issue 4, 2008, Pages 459-472

  Malcolm, Robert ^a   Olive, M Foster ^a   Lechner, William ^a  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

Alcohol dependence; Cocaine dependence; Disulfiram; Randomized clinical trials; RCTs; Safety

Indexed keywords

ACAMPROSATE; ACETALDEHYDE; ALCOHOL; AMPRENAVIR; ANALGESIC AGENT; ANTICOAGULANT AGENT; ANTIDEPRESSANT AGENT; ANTIDIABETIC AGENT; ANTIINFECTIVE AGENT; ASCORBIC ACID; BUPRENORPHINE; CEFOPERAZONE; CEFOTETAN; CEPHALOSPORIN DERIVATIVE; COCAINE; DIETHYLDITHIOCARBAMIC ACID; DISULFIRAM; ERYTHROCYTE DEALDEHYDE HYDROGENASE; HYDROGENASE; IMIPRAMINE; ISONIAZID; KETOCONAZOLE; METHADONE; METRONIDAZOLE; MONOAMINE OXIDASE INHIBITOR; NALTREXONE; OMEPRAZOLE; PLACEBO; RIBOFLAVIN; UNINDEXED DRUG;

ALCOHOLISM; ANXIETY; AREA UNDER THE CURVE; BREATHING RATE; CLINICAL EDUCATION; CLINICAL PRACTICE; CLINICAL TRIAL; COCAINE DEPENDENCE; COGNITION; COMORBIDITY; CONTROLLED CLINICAL TRIAL; DEPRESSION; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DROWSINESS; DRUG ALCOHOL INTERACTION; DRUG BINDING; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG EXCRETION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG INFORMATION; DRUG MECHANISM; DRUG MEGADOSE; DRUG METABOLISM; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; FATIGUE; FLUSHING; GASTROINTESTINAL SYMPTOM; HALITOSIS; HEART PALPITATION; HEART RATE; HUMAN; HYPOTENSION; HYPOVOLEMIC SHOCK; INFORMED CONSENT; INSOMNIA; IRRITABILITY; LOW DRUG DOSE; MAJOR DEPRESSION; NAUSEA; NEUROPATHY; OLFACTORY DISCRIMINATION; PATIENT COMPLIANCE; PRACTICE GUIDELINE; PSYCHOSIS; PULSE RATE; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; REVIEW; SEIZURE; SEXUAL DYSFUNCTION; SIDE EFFECT; SKIN DISEASE; SOMNOLENCE; SUICIDAL IDEATION; SYSTOLIC BLOOD PRESSURE; TACHYCARDIA; TASTE DISCRIMINATION; THORAX PAIN; TOXIC HEPATITIS; TREATMENT DURATION; VASODILATATION;

ALCOHOL DETERRENTS; ALCOHOLISM; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; COCAINE-RELATED DISORDERS; DISULFIRAM; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS;

EID: 48749097099     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.7.4.459     Document Type: Review

References (55)

1. Williams EE. Effects of alcohol on workers with carbon disulfide. JAMA 1937;109:1472-3
2. Christensen JK, Rønsted P, Vaag UH. Side effects after disulfiram. Acta Psychiatr Scand 1984;69:265-73
3. Johnson BA. Update on neuropharmacological treatments for alcoholism: scientific basis and clinical findings. Biochem Pharmacol 2008;75:34-56
4. Carroll K, Ziedonis D, O'Malley S, et al. Pharmacologic interventions for alcohol- and cocaine-abusing individuals: a pilot study of disulfiram vs naltrexone. Am J Addictions 1993;3:77-9
5. Carroll KM, Nich C, Ball CA, et al. Treatment of cocaine and alcohol dependence with psychotherapy and disulfiram. Addictions 1998;93:713-28
6. George TP, Chawarski MC, Pakes J, et al. Disulfiram versus placebo for cocaine dependence in buprenorphine-maintained subjects: a preliminary trial. Soc Biol Psychiatry 2000;47:1080-6
7. Petrakis IL, Carroll KM, Nich C, et al. Disulfiram treatment for cocaine dependence in methadone-maintained opioid addicts. Addiction 2000;95:219-28
8. Carroll KM, Fenton LR, Ball SA, et al. Efficacy of disulfiram and cognitive behavior therapy in cocaine-dependent outpatients. Arch Gen Psychiatry 2004;61:264-72
9. Pettinati HM, Kampman KM, Lynch KG, et al. A double blind, placebo-controlled trial that combines disulfiram and naltrexone for treating co-occurring cocaine and alcohol dependence. Addict Behav 2008;33(5):651-67
10. Wickstrom M, Danielsson K, Rickardson L, et al. Pharmacological profiling of disulfiram using human tumor cell lines and human tumor cells from patients. Biochem Pharmacol 2007;73:25-33
11. Jacobsen E. Deaths of alcoholic patients treated with disulfiram (tetraethylthiuram disulfide) in Denmark. J Stud Alcohol 1952;13:16-26
12. Haley TJ. Disulfiram (tetraethylthioperoxydicarbonic diamide): a reappraisal of its toxicity and therapeutic application. Drug Metab Rev 1979;9(2):319-35
13. Chick J. Safety issues concerning the use of disulfiram in treating alcohol dependence. Drug Saf 1999;20(5):427-35
14. Fuller RK, Gordis E. Does disulfiram have a role in alcoholism treatment today? Addiction 2004;99:21-4
15. Saxon AJ, Sloan KL, Reoux J, Haver VM. Disulfiram use in patients with abnormal liver function test results. J Clin Psychiatry 1998;59:313-6
16. Brewer C, Hardt F. Preventing disulfiram hepatitis in alcohol abusers: inappropriate guidelines and the significance of nickel allergy. Addict Biol 1999;4:303-8
17. Björnsson E, Nordlinder H, Olsson R. Clinical characteristics and prognostic markers in disulfiram-induced liver injury. J Hepatol 2006;44:791-7
18. Sofuoglu M, Kosten TR. Emerging pharmacological strategies in the fight against cocaine addiction. Expert Opin Emerging Drugs 2006;11(1):91-8
19. Suh JJ, Pettinati HM, Kampman KM, O'Brien CP. The status of disulfiram: a half of a century later. J Clin Psychopharmacol 2006;26(3):290-302
20. Becker MC, Sugarman G. Death following 'test drink' of alcohol in patients receiving Antabuse®. JAMA 1952;149(6):568-71
21. Savas MC. Disulfiram-ethanol test reaction: significance of supervision. Ann Pharmacother 1997;31:374-5
22. O'Brien C. Drug addiction and drug abuse. In: Hardman J, Limbird L, editors, Goodman & Gilman's The pharmacological basis of therapeutics, 10th edition. New York: McGraw-Hill; 2001. p. 621-42
23. Lipsky JJ, Shen ML, Naylor S. In vitro inhibition of aldehyde dehydrogenase by disulfiram and metabolites. Chem Biol Interact 2001;130-132:93-102
24. Faiman MD. Biochemical pharmacology of disulfiram. In: Majehowicz E, Nobel EP, editors, Biochemistry and pharmacology of ethanol. New York: Plenum Press; 1979. p. 325-48
25. McCance-Katz EF, Kosten TR, Jatlow P. Chronic disulfiram treatment effects on intranasal cocaine administration: initial results. Soc Biol Psychiatry 1998;43:540-3
26. Frye RF, Branch RA. Effect of chronic disulfiram administration on the activities of CYP1A2, CYP2C19, CYP2D6, CYP2E1, and N-acetyltransferase in healthy human subjects. Br J Clin Pharmacol 2002;53:155-62
27. Goldstein M, Anagoste B, Lauber E, McKereghan MR. Inhibition of dopamine beta-hydroxylase by disulfiram. Life Sci 1964;3:763-7
28. Mussachio J, Kopin IJ, Snyder S. Effects of disulfiram on tissue norepinephrine content and subcellular distributions of dopamine, tyramine and their beta-hydroxylated metabolites. Life Sci 1964;3:769-75
29. Faiman MD, Jensen JC, Lacoursiere RB. Elimination kinetics of disulfiram in alcoholics after single and repeated doses. Clin Pharm Ther 1984;36(4):520-6
30. Johansson B. A review of the pharmacokinetics and pharmacodynamics of disulfiram and its metabolites. Acta Psychiatr Scand 1992;86(Suppl 369):15-26
31. Antabuse package insert. East Hanover, NJ: Odyssey Pharmaceuticals, Inc.; 2001
32. PDR. Physicians' desk reference. 56th editon. Montvale, NJ: Medical Economics Company; 2002. p. 2444-2445
33. Rastegar DA, Fingerhood MI. Chapter 5. Addiction medicine: an evidence-based handbook. Lippincott, Williams & Wilkins: Baltimore; 2005
34. Rosenbaum JF, Arana GW, Hyman SE, et al. Chapter 6. Handbook of psychiatric drug therapy. 5th edition. Lippincott, Williams & Wilkins: Baltimore; 2005
35. Wallace C, Roache J, Newton T, et al. Phase I clinical safety study of the three-way drug interactions between disulfiram, cocaine, and alcohol in cocaine dependent research volunteers. 67th Annual Scientific Meeting on the College on Problems of Drug Dependence; June 2005; Orlando, USA
36. Brewer C. How effective is the standard dose of disulfiram? A review of the alcohol-disulfiram reaction in practice. Br J Psychiatry 1984;144:202-4
37. Christensen JK, Møller IB, Rønsted P, et al. Dose-effect relationship of disulfiram in human volunteers. I. Clinical studies. Pharmacol Toxicol 1991;68:163-5
38. Johansson B, Angello HR, Christensen JK, et al. Dose-effect relationship of disulfiram in human volunteers. II. A study of the relation between the disulfiram-alcohol reaction and plasma concentrations of acetaldehyde, diethyldithiocarbamic acid methyl ester, and erythrocyte aldehyde dehydrogenase activity. Pharmacol Toxicol 1991;68(3):166-70
39. Scott D, Taylor R. Health-related effects of genetic variations of alcohol-metabolizing enzymes in African Americans. Alcohol Res Health 2007;30(1):18-21
40. Thomasson HR, Edenberg HJ, Crabb DW, et al. Alcohol and aldehyde dehydrogenase genotypes and alcoholism in Chinese men. Am J Hum Genet 1991;48:677-81
41. Bourdélat-Parks B, Anderson G, Donaldson Z, et al. Effects of dopamine β-hydroxylase genotype and disulfiram inhibition on catecholamine homeostasis in mice. Psychopharmacology 2005;183(1):72-80
42. Cubells J, Zabetian C. Human genetics of plasma dopamine beta-hydroxylase activity: applications to research in psychiatry and neurology. Psychopharmacology 2004;174:463-76
43. Fuller RK, Branchey L, Brightwell DR, et al. Disulfiram treatment of alcoholism: a Veterans Administration cooperative study. JAMA 1986;256:1449-55
44. Chick J, Gough K, Falkows W, et al. Disulfiram treatment of alcoholism. Br J Psychiatry 1992;161:84-9
45. De Sousa A, De Sousa A. An open randomized study comparing disulfiram and acamprosare in the treatment of alcohol dependence. Alcohol Alcoholism 2006;40(6):545-8
46. Laaksonen E, Koski-Jannes A, Salaspuro M. et al. A randomized, multicentre, open label, comparative trial of disulfiram, naltrexone, and acamprosate in the treatment of alcohol dependence. Alcohol Alcoholism 2008;43(1):53-61
47. Benowitz NL. Clinical pharmacology and toxicology of cocaine. Pharmacol Toxicol 1993;72:3-12
48. McCance-Katz EF, Kosten TR, Jatlow P. Disulfiram effects on acute cocaine administration. Drug Alcohol Depend 1998;52:27-39
49. Baker JR, Jatlow P, McCance-Katz E. Disulfiram effects on responses to intravenous cocaine administration. Drug Alcohol Depend 2007;87:202-9
50. Roache & Wallace. Pers. Commun. January 2008
51. Macleod S, Sellers E, Giles H, et al. Interactions of disulfiram with benzodiazepines. Clin Pharmacol Ther 1978;24(1):58-79
52. MICROMEDEX. 2008. Available at: http://www.library.ucsf.edu/db/ record.html?idrecord=82
53. Martin B, Beresford TP. Disulfiram in context: structure and safety. J Clin Psychopharmacol 2007;27(4):415-7
54. United Nations Office of Drugs and Crime (UNODC). Global illicit drug trends. Executive summary. Vienna: UNODC; 2003
55. Kosten T. Stimulant abuse pharmacotherapy: from Antabuse to Zenova-vax with a lot of help from my friends. American Academy of Addiction Psychiatry, 18th annual meeting; 30 Nov 2007; San Diego, USA