Toxicological considerations in the prescription of baclofen for the treatment of substance use disorders

References

• Young RR. Treatment of spastic paresis. N Engl J Med. 1989;320:1553–1555.
   Google Scholar
• Leggio L, Garbutt JC, Addolorato G. Effectiveness and safety of baclofen in the treatment of alcohol dependent patients. CNS Neurol Disord Drug Targets. 2010;9:33–44.
   Google Scholar
• Imbert B, Alvarez JC, Simon N. Anticraving effect of baclofen in alcohol-dependent patients. Alcohol Clin Exp Res. 2015;39(9):1602–1608.
   Google Scholar
• Agabio R, Sinclair JM, Addolorato G, et al., Baclofen for the treatment of alcohol use disorder: the cagliari statement. Lancet Psychiatry. 5(12): 957–960. 2018.
   Google Scholar
• Ameisen O. Complete and prolonged suppression of symptoms and consequences of alcohol-dependence using high-dose baclofen: a self-case report of a physician. Alcohol Alcohol. 2005;40(2):147–150.
   Google Scholar
• Leger M, Brunet M, Le Roux G, et al. Baclofen self-poisoning in the era of changing indication: multicentric reports to a French poison control centre. Alcohol Alcohol. 2017;52(6):665–670.
   Google Scholar
• Jamshidi N, Morley KC, Cairns R, et al. A review of baclofen overdoses in Australia: calls to a poisons information centre and a case series. Alcohol Alcohol. 2019;54(1):73–78.
   Google Scholar
• Agabio R, Preti A, Gessa GL. Efficacy and tolerability of baclofen in substance use disorders: a systematic review. Eur Addict Res. 2013;19(6):325–345.
   Google Scholar
• Agabio R, Marras P, Addolorato G, et al., Baclofen suppresses alcohol intake and craving for alcohol in a schizophrenic alcohol-dependent patient: a case report. J Clin Psychopharmacol. 27(3): 319–320. 2007.
   Google Scholar
• Franchitto N, Pelissier F, Lauque D, et al. Self-intoxication with baclofen in alcohol-dependent patients with co-existing psychiatric illness: an emergency department case series. Alcohol Alcohol. 2014;49:79–83.
   Google Scholar
• Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.
   Google Scholar
• Sullivan R, Hodgman MJ, Kao L, et al. Baclofen overdose mimicking brain death. Clin Toxicol (Phila). 2012;50(2):141–144.
   Google Scholar
• Pommier P, Debaty G, Bartoli M, et al. Severity of deliberate acute baclofen poisoning: a nonconcurrent cohort study. Basic Clin Pharmacol Toxicol. 2014;114(4):360–364.
   Google Scholar
• Rolland B, Deheul S, Danel T, et al. A case of de novo seizures following a probable interaction of high-dose baclofen with alcohol. Alcohol Alcohol. 2012;47(5):577–580.
   Google Scholar
• Weißhaar GF, Hoemberg M, Bender K, et al. Baclofen intoxication: a “fun drug” causing deep coma and nonconvulsive status epilepticus–a case report and review of the literature. Eur J Pediatr. 2012;171(10):1541–1547.
   Google Scholar
• Franchitto N, Rolland B, Pelissier F, et al. How to manage self-poisoning with baclofen in alcohol use disorder? Current updates. Front Psychiatry. 2018;9:417.
   Google Scholar
• Lee TH, Chen SS, Su SL, et al. Baclofen intoxication: report of four cases and review of the literature. Clin Neuropharmacol. 1992;15(1):56–62.
   Google Scholar
• Nugent S, Katz MD, Little TE. Baclofen overdose with cardiac conduction abnormalities: case report and review of the literature. J Toxicol Clin Toxicol. 1986;24(4):321–328.
   Google Scholar
• Holla B, Gowda GS, Prabhu L, et al. High doses of baclofen as suicide attempt in patients with alcohol use disorders - A serious concern. Asian J Psychiatr. 2015;17:99–100.
   Google Scholar
• Dario A, Tomei G. A benefit-risk assessment of baclofen in severe spinal spasticity. Drug Saf. 2004;27:799–818.
   Google Scholar
• Beraha EM, Salemink E, Goudriaan AE, et al. Efficacy and safety of high-dose baclofen for the treatment of alcohol dependence: A multicentre, randomised, double-blind controlled trial. Eur Neuropsychopharmacol. 2016;26(12):1950–1959.
   Google Scholar
• Auffret M, Labreuche J, Duhamel A, et al. Proactive regional pharmacovigilance system versus national spontaneous reporting for collecting safety data on concerning off-label prescribing practices: an example with baclofen and alcohol dependence in France. Drug Saf. 2017;40(3):257–262.
   Google Scholar
• Auffret M, Rolland B, Deheul S, et al. Severe tinnitus induced by off-label baclofen. Ann Pharmacother. 2014;48(5):656–659.
   Google Scholar
• Dore GM, Lo K, Juckes L, et al. Clinical experience with baclofen in the management of alcohol-dependent patients with psychiatric comorbidity: a selected case series. Alcohol Alcohol. 2011;46(6):714–720.
   Google Scholar
• Rolland B, Jaillette E, Carton L, et al. Assessing alcohol versus baclofen withdrawal syndrome in patients treated with baclofen for alcohol use disorder. J Clin Psychopharmacol. 2014;34(1):153–156.
   Google Scholar
• Perogamvros L, Pépin JL, Thorens G, et al. Baclofen-associated onset of central sleep apnea in alcohol use disorder: a case report. Respiration. 2015;90(6):507–511.
   Google Scholar
• Geoffroy PA, Auffret M, Deheul S, et al. Baclofen-induced manic symptoms: case report and systematic review. Psychosomatics. 2014;55(4):326–332.
   Google Scholar
• Rigal L, Legay Hoang L, Alexandre-Dubroeucq C, et al. Tolerability of high-dose baclofen in the treatment of patients with alcohol disorders: a retrospective study. Alcohol Alcohol. 2015;50(5):551–557.
   Google Scholar
• Bence C, Cottencin O, Deheul S, et al. Baclofen-induced edema in alcohol use disorders. J Clin Pharmacol. 2014;54(4):478–481.
   Google Scholar
• Olivier PY, Joyeux-Faure M, Gentina T, et al. Severe central sleep apnea associated with chronic baclofen therapy: a case series. Chest. 2016;149(5):e127–31.
   Google Scholar
• Revol B, Jullian-Desayes I, Bailly S, et al., Baclofen and sleep apnoea syndrome: analysis of VigiBase, the WHO pharmacovigilance database. Eur Respir J. 51(1): 1701855. 2018.
   Google Scholar
• Pelissier F, de Haro L, Cardona F, et al. Self-poisoning with baclofen in alcohol-dependent patients: national reports to French poison control centers, 2008–2013. Clin Toxicol (Phila). 2017;55(4):275–284.
   Google Scholar
• Arbouw ME, Hoge HL, Meulenbelt J, et al. Increase of baclofen intoxications: risks involved and management. Neth J Med. 2014 Nov;72(9):497–499.
   Google Scholar
• Leung NY, Whyte IM, Isbister GK. Baclofen overdose: defining the spectrum of toxicity. Emerg Med Australas. 2006;18(1):77–82.
   Google Scholar
• Perry HE, Wright RO, Shannon MW, et al. Baclofen overdose: drug experimentation in a group of adolescents. Pediatrics. 1998;101(6):1045–1048.
   Google Scholar
• Charifou Y, Martinet O, Jabot J, et al. Baclofen intoxication cases in an intensive care unit. Anaesth Crit Care Pain Med. 2016;35(2):169–170.
   Google Scholar
• Reichmuth P, Blanc AL, Tagan D. Unintentional baclofen intoxication in the management of alcohol use disorder. BMJ Case Rep. 2015;22:2015.
   Google Scholar
• Muanda FT, Weir MA, Bathini L, et al., Association of baclofen with encephalopathy in patients with chronic kidney disease. JAMA. 322(20): 1987–1995. 2019.
   Google Scholar
• de Beaurepaire R, Sinclair JMA, Heydtmann M, et al. The use of baclofen as a treatment for alcohol use disorder: a clinical practice perspective. Front Psychiatry. 2018;9:708.
   Google Scholar
• Marsot A, Imbert B, Alvarez JC, et al. High variability in the exposure of baclofen in alcohol-dependent patients. Alcohol Clin Exp Res. 2014;38(2):316–321.
   Google Scholar
• Chern TL, Kwan A. Flumazenil-induced seizure accompanying benzodiazepine and baclofen intoxication. Am J Emerg Med. 1996;14(2):231–232.
   Google Scholar
• Hsieh MJ, Chen SC, Weng TI, et al. Treating baclofen overdose by hemodialysis. Am J Emergency Med. 2012;30(8):1654.e5–7.
   Google Scholar
• Haubenstock A, Hruby K, Jager U, et al. Baclofen (Lioresal) intoxication report of 4 cases and review of the literature. J Toxicol Clin Toxicol. 1983;20(1):59–68.
   Google Scholar
• Pape E, Roman E, Scala-Bertola J, et al., Death of an alcohol-dependent patient following intentional drug intoxication: implication of baclofen? Eur Addict Res. 20(6): 300–304. 2014.
   Google Scholar
• Chaignot C, Zureik M, Rey G, et al., Risk of hospitalisation and death related to baclofen for alcohol use disorders: comparison with nalmefene, acamprosate, and naltrexone in a cohort study of 165 334 patients between 2009 and 2015 in France. Pharmacoepidemiol Drug Saf. 27(11): 1239–1248. 2018.
   Google Scholar
• Addolorato G, Caputo F, Capristo E, et al. Ability of baclofen in reducing alcohol craving and intake: II–preliminary clinical evidence. Alcohol Clin Exp Res. 2000;24(1):67–71.
   Google Scholar
• Addolorato G, Caputo F, Capristo E, et al. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002;112(3):226–229.
   Google Scholar
• Addolorato G. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002;37(5):504–508.
   Google Scholar
• Flannery BA, Garbutt JC, Cody MW, et al. Baclofen for alcohol dependence: a preliminary open-label study. Alcohol Clin Exp Res. 2004;28(10):1517–1523.
   Google Scholar
• Addolorato G, Leggio L, Agabio R, et al. Baclofen: a new drug for the treatment of alcohol dependence. Int J Clin Pract. 2006;60(8):1003–1008.
   Google Scholar
• Garbutt JC, Kampov-Polevoy AB, Gallop R, et al. Efficacy and safety of baclofen for alcohol dependence: a randomized, double-blind, placebo-controlled trial. Alcohol Clin Exp Res. 2010;34(11):1849–1857.
   Google Scholar
• Müller CA, Geisel O, Pelz P, et al. High-dose baclofen for the treatment of alcohol dependence (BACLAD study): a randomized, placebo-controlled trial. Eur Neuropsychopharmacol. 2015;25(8):1167–1177.
   Google Scholar
• Liu J, Wang LN. Baclofen for alcohol withdrawal. Cochrane Database Syst Rev. 2015;1(4):CD008502.
   Google Scholar
• Minozzi S, Saulle R, Rösner S. Baclofen for alcohol use disorder. Cochrane Database Syst Rev. 2018;11:CD012557.
   Google Scholar
• Kahn R, Biswas K, Childress AR, et al. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals. Drug Alcohol Depend. 2009;103(1–2):59–64.
   Google Scholar
• Kaplan GB, McRoberts RL, Smokler HJ. Baclofen as adjunctive treatment for a patient with cocaine dependence and schizoaffective disorder. J Clin Psychopharmacol. 2004;24(5):574–575.
   Google Scholar
• Haney M, Hart CL, Foltin RW. Effects of baclofen on cocaine self-administration: opioid- and nonopioid-dependent volunteers. Neuropsychopharmacology. 2006;31(8):1814–1821.
   Google Scholar
• Nanjayya SB, Shivappa M, Chand PK, et al. Baclofen in cannabis dependence syndrome. Biol Psychiatry. 2010;68(3):e9–10.
   Google Scholar
• Imbert B, Labrune N, Lancon C, et al. Baclofen in the management of cannabis dependence syndrome. Ther Adv Psychopharmacol. 2014;4(1):50–52.
   Google Scholar
• Krystal JH, McDougle CJ, Kosten TR, et al. Baclofen-assisted detoxification from opiates. A pilot study. J Subst Abuse Treat. 1992;9(2):139–142.
   Google Scholar
• Assadi SM, Radgoodarzi R, Ahmadi-Abhari SA. Baclofen for maintenance treatment of opioid dependence: a randomized double-blind placebo-controlled clinical trial [ISRCTN32121581]. BMC Psychiatry. 2003;3:16.
   Google Scholar
• Kamal RM, Loonen AJ, Dijkstra BA, et al. Baclofen as relapse prevention in the treatment of gamma-hydroxybutyrate dependence: a case series. J Clin Psychopharmacol. 2015;35(3):313–318.
   Google Scholar
• Beurmanjer H, Kamal RM, de Jong CAJ, et al. Baclofen to prevent relapse in gamma-hydroxybutyrate (GHB)-dependent patients: a multicentre, open-label, non-randomized, controlled trial. CNS Drugs. 2018;32(5):437–442.
   Google Scholar
• Cousins MS, Stamat HM, de Wit H. Effects of a single dose of baclofen on self-reported subjective effects and tobacco smoking. Nicotine Tob Res. 2001;3(2):123–129.
   Google Scholar
• Heinzerling KG, Shoptaw S, Peck JA, et al. Randomized, placebo-controlled trial of baclofen and gabapentin for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2006;85(3):177–184.
   Google Scholar
• Richter E, Baldovini A, Blasco V, et al. About baclofen withdrawal syndrome. Presse Med. 2016;45(5):547–548.
   Google Scholar
• Hamel Sénécal L, Chrétien B, Jean-Jacques PY, et al. A case of drug dependence syndrome to baclofen following high-dose therapy. J Clin Psychopharmacol. 2018;38(3):277–279.
   Google Scholar
• Rivas DA, Chancellor MB, Hill K, et al. Neurological manifestations of baclofen withdrawal. J Urol. 1993;150(6):1903–1905.
   Google Scholar
• Nasti JJ, Brakoulias V. Chronic baclofen abuse and withdrawal delirium. Aust N Z J Psychiatry. 2011;45(1):86–87.
   Google Scholar
• Chawla JM, Sagar R. Baclofen-induced psychosis. Ann Pharmacother. 2006;40(11):2071–2073.
   Google Scholar
• Peng CT, Ger J, Yang CC, et al. Prolonged severe withdrawal symptoms after acute-on-chronic baclofen overdose. J Toxicol Clin Toxicol. 1998;36(4):359–363.
   Google Scholar
• Vourc’h M, Dailly E, Hourmant Y, et al. Pharmacokinetics and toxicity of high-dose baclofen in ICU patients. Prog Neuropsychopharmacol Biol Psychiatry. 2019;92:450–456.
   Google Scholar
• Chevillard L, Sabo N, Tod M, et al. Population pharmacokinetics of oral baclofen at steady-state in alcoholic-dependent adult patients. Fundam Clin Pharmacol. 2018;32(2):239–248.
   Google Scholar
• Simon N, Franchitto N, Rolland B. Pharmacokinetic studies of baclofen are not sufficient to establish an optimized dosage for management of alcohol disorder. Front Psychiatry. 2018;9:485.
   Google Scholar
• Simon N, Moirand R, Dematteis M, et al. Full-profile pharmacokinetic study of high dose baclofen in subjects with alcohol use disorder. Front Psychiatry. 2018;9:385.
   Google Scholar
• Cleophax C, Goncalves A, Chasport C, et al. Usefulness of plasma drug monitoring in severe baclofen poisoning. Clin Toxicol (Phila). 2015;53(9):923–924.
   Google Scholar
• Gerkin R, Curry SC, Vance MV, et al. First-order elimination kinetics following baclofen overdose. Ann Emerg Med. 1986;15(7):843–846.
   Google Scholar
• Bucknam W. Suppression of symptoms of alcohol dependence and craving using high-dose baclofen. Alcohol Alcohol. 2006;42(2):158–160.
   Google Scholar
• Saissy JM, Vitris M, Demazière J, et al. Flumazenil counteracts intrathecal baclofen-induced central nervous system depression in tetanus. Anesthesiology. 1992;76(6):1051–1053.
   Google Scholar
• Journiac K, Pascuttini F, Touzeau D. The baclofene saga and the paradigm shift in alcohol addiction treatment. Presse Med. 2016;45(12 Pt 1):1117–1123.
   Google Scholar
• de Beaurepaire R. The use of very high-doses of baclofen for the treatment of alcohol-dependence: a case series. Front Psychiatry. 2014;5:143.
   Google Scholar