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Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT06269627

Recruitment Status : Not yet recruiting

First Posted : February 21, 2024

Last Update Posted : May 14, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Not yet recruiting
Estimated Primary Completion Date :	December 31, 2025
Estimated Study Completion Date :	December 31, 2026

Publications:

Jonas DE, Amick HR, Feltner C, Bobashev G, Thomas K, Wines R, Kim MM, Shanahan E, Gass CE, Rowe CJ, Garbutt JC. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014 May 14;311(18):1889-900. doi: 10.1001/jama.2014.3628.

Sacks JJ, Gonzales KR, Bouchery EE, Tomedi LE, Brewer RD. 2010 National and State Costs of Excessive Alcohol Consumption. Am J Prev Med. 2015 Nov;49(5):e73-e79. doi: 10.1016/j.amepre.2015.05.031. Epub 2015 Oct 1.

Bauer LO. Predicting relapse to alcohol and drug abuse via quantitative electroencephalography. Neuropsychopharmacology. 2001 Sep;25(3):332-40. doi: 10.1016/S0893-133X(01)00236-6.

Rangaswamy M, Porjesz B, Chorlian DB, Wang K, Jones KA, Bauer LO, Rohrbaugh J, O'Connor SJ, Kuperman S, Reich T, Begleiter H. Beta power in the EEG of alcoholics. Biol Psychiatry. 2002 Oct 15;52(8):831-42. doi: 10.1016/s0006-3223(02)01362-8.

Rangaswamy M, Porjesz B, Chorlian DB, Wang K, Jones KA, Kuperman S, Rohrbaugh J, O'Connor SJ, Bauer LO, Reich T, Begleiter H. Resting EEG in offspring of male alcoholics: beta frequencies. Int J Psychophysiol. 2004 Feb;51(3):239-51. doi: 10.1016/j.ijpsycho.2003.09.003.

Sullivan PF, Daly MJ, O'Donovan M. Genetic architectures of psychiatric disorders: the emerging picture and its implications. Nat Rev Genet. 2012 Jul 10;13(8):537-51. doi: 10.1038/nrg3240.

Davies M. The role of GABAA receptors in mediating the effects of alcohol in the central nervous system. J Psychiatry Neurosci. 2003 Jul;28(4):263-74.

Kalk NJ, Lingford-Hughes AR. The clinical pharmacology of acamprosate. Br J Clin Pharmacol. 2014 Feb;77(2):315-23. doi: 10.1111/bcp.12070.

Naassila M, Hammoumi S, Legrand E, Durbin P, Daoust M. Mechanism of action of acamprosate. Part I. Characterization of spermidine-sensitive acamprosate binding site in rat brain. Alcohol Clin Exp Res. 1998 Jun;22(4):802-9.

Umhau JC, Momenan R, Schwandt ML, Singley E, Lifshitz M, Doty L, Adams LJ, Vengeliene V, Spanagel R, Zhang Y, Shen J, George DT, Hommer D, Heilig M. Effect of acamprosate on magnetic resonance spectroscopy measures of central glutamate in detoxified alcohol-dependent individuals: a randomized controlled experimental medicine study. Arch Gen Psychiatry. 2010 Oct;67(10):1069-77. doi: 10.1001/archgenpsychiatry.2010.125.

Harris BR, Prendergast MA, Gibson DA, Rogers DT, Blanchard JA, Holley RC, Fu MC, Hart SR, Pedigo NW, Littleton JM. Acamprosate inhibits the binding and neurotoxic effects of trans-ACPD, suggesting a novel site of action at metabotropic glutamate receptors. Alcohol Clin Exp Res. 2002 Dec;26(12):1779-93. doi: 10.1097/01.ALC.0000042011.99580.98.

Dahchour A, De Witte P. Effects of acamprosate on excitatory amino acids during multiple ethanol withdrawal periods. Alcohol Clin Exp Res. 2003 Mar;27(3):465-70. doi: 10.1097/01.ALC.0000056617.68874.18.

Spanagel R, Pendyala G, Abarca C, Zghoul T, Sanchis-Segura C, Magnone MC, Lascorz J, Depner M, Holzberg D, Soyka M, Schreiber S, Matsuda F, Lathrop M, Schumann G, Albrecht U. The clock gene Per2 influences the glutamatergic system and modulates alcohol consumption. Nat Med. 2005 Jan;11(1):35-42. doi: 10.1038/nm1163. Epub 2004 Dec 19. Erratum In: Nat Med. 2005 Feb;11(2):233.

Mason BJ, Ownby RL. Acamprosate for the treatment of alcohol dependence: a review of double-blind, placebo-controlled trials. CNS Spectr. 2000 Feb;5(2):58-69. doi: 10.1017/s1092852900012827.

Witkiewitz K, Saville K, Hamreus K. Acamprosate for treatment of alcohol dependence: mechanisms, efficacy, and clinical utility. Ther Clin Risk Manag. 2012;8:45-53. doi: 10.2147/TCRM.S23184. Epub 2012 Feb 1.

Propping P, Kruger J, Mark N. Genetic disposition to alcoholism. An EEG study in alcoholics and their relatives. Hum Genet. 1981;59(1):51-9. doi: 10.1007/BF00278854.

Bauer LO. Electroencephalographic and autonomic predictors of relapse in alcohol-dependent patients. Alcohol Clin Exp Res. 1994 Jun;18(3):755-60. doi: 10.1111/j.1530-0277.1994.tb00942.x.

Bauer LO, Gross JB, Meyer RE, Greenblatt DJ. Chronic alcohol abuse and the acute sedative and neurophysiologic effects of midazolam. Psychopharmacology (Berl). 1997 Oct;133(3):293-9. doi: 10.1007/s002130050404.

Costa L, Bauer L. Quantitative electroencephalographic differences associated with alcohol, cocaine, heroin and dual-substance dependence. Drug Alcohol Depend. 1997 Jun 6;46(1-2):87-93. doi: 10.1016/s0376-8716(97)00058-6.

Winterer G, Kloppel B, Heinz A, Ziller M, Dufeu P, Schmidt LG, Herrmann WM. Quantitative EEG (QEEG) predicts relapse in patients with chronic alcoholism and points to a frontally pronounced cerebral disturbance. Psychiatry Res. 1998 Mar 20;78(1-2):101-13. doi: 10.1016/s0165-1781(97)00148-0.

Kopell N, Ermentrout GB, Whittington MA, Traub RD. Gamma rhythms and beta rhythms have different synchronization properties. Proc Natl Acad Sci U S A. 2000 Feb 15;97(4):1867-72. doi: 10.1073/pnas.97.4.1867.

Coutin-Churchman P, Moreno R, Anez Y, Vergara F. Clinical correlates of quantitative EEG alterations in alcoholic patients. Clin Neurophysiol. 2006 Apr;117(4):740-51. doi: 10.1016/j.clinph.2005.12.021. Epub 2006 Feb 21.

Nair Chaitanya M, Jayakkumar S, Chong E, Yeow CH. A wearable, EEG-based massage headband for anxiety alleviation. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:3557-3560. doi: 10.1109/EMBC.2017.8037625.

Chen C, Yu X, Belkacem AN, Lu L, Li P, Zhang Z, Wang X, Tan W, Gao Q, Shin D, Wang C, Sha S, Zhao X, Ming D. EEG-Based Anxious States Classification Using Affective BCI-Based Closed Neurofeedback System. J Med Biol Eng. 2021;41(2):155-164. doi: 10.1007/s40846-020-00596-7. Epub 2021 Feb 5.

Muhammad F, Al-Ahmadi S. Human state anxiety classification framework using EEG signals in response to exposure therapy. PLoS One. 2022 Mar 18;17(3):e0265679. doi: 10.1371/journal.pone.0265679. eCollection 2022.

Traub RD, Whittington MA, Colling SB, Buzsaki G, Jefferys JG. Analysis of gamma rhythms in the rat hippocampus in vitro and in vivo. J Physiol. 1996 Jun 1;493 ( Pt 2)(Pt 2):471-84. doi: 10.1113/jphysiol.1996.sp021397.

Whittington MA, Jefferys JG, Traub RD. Effects of intravenous anaesthetic agents on fast inhibitory oscillations in the rat hippocampus in vitro. Br J Pharmacol. 1996 Aug;118(8):1977-86. doi: 10.1111/j.1476-5381.1996.tb15633.x. Erratum In: Br J Pharmacol 1996 Nov;119(6):1291.

Porjesz B, Almasy L, Edenberg HJ, Wang K, Chorlian DB, Foroud T, Goate A, Rice JP, O'Connor SJ, Rohrbaugh J, Kuperman S, Bauer LO, Crowe RR, Schuckit MA, Hesselbrock V, Conneally PM, Tischfield JA, Li TK, Reich T, Begleiter H. Linkage disequilibrium between the beta frequency of the human EEG and a GABAA receptor gene locus. Proc Natl Acad Sci U S A. 2002 Mar 19;99(6):3729-33. doi: 10.1073/pnas.052716399. Epub 2002 Mar 12.

Faulkner HJ, Traub RD, Whittington MA. Disruption of synchronous gamma oscillations in the rat hippocampal slice: a common mechanism of anaesthetic drug action. Br J Pharmacol. 1998 Oct;125(3):483-92. doi: 10.1038/sj.bjp.0702113.

Saletu-Zyhlarz GM, Arnold O, Anderer P, Oberndorfer S, Walter H, Lesch OM, Boning J, Saletu B. Differences in brain function between relapsing and abstaining alcohol-dependent patients, evaluated by EEG mapping. Alcohol Alcohol. 2004 May-Jun;39(3):233-40. doi: 10.1093/alcalc/agh041.

Klimesch W. EEG alpha and theta oscillations reflect cognitive and memory performance: a review and analysis. Brain Res Brain Res Rev. 1999 Apr;29(2-3):169-95. doi: 10.1016/s0165-0173(98)00056-3.

Anderson NE, Baldridge RM, Stanford MS. P3a amplitude predicts successful treatment program completion in substance-dependent individuals. Subst Use Misuse. 2011;46(5):669-77. doi: 10.3109/10826084.2010.528123. Epub 2010 Nov 1.

Wan L, Baldridge RM, Colby AM, Stanford MS. Association of P3 amplitude to treatment completion in substance dependent individuals. Psychiatry Res. 2010 May 15;177(1-2):223-7. doi: 10.1016/j.psychres.2009.01.033. Epub 2010 Apr 9.

Costa L, Bauer L, Kuperman S, Porjesz B, O'Connor S, Hesselbrock V, Rohrbaugh J, Begleiter H. Frontal P300 decrements, alcohol dependence, and antisocial personality disorder. Biol Psychiatry. 2000 Jun 15;47(12):1064-71. doi: 10.1016/s0006-3223(99)00317-0.

Hada M, Porjesz B, Begleiter H, Polich J. Auditory P3a assessment of male alcoholics. Biol Psychiatry. 2000 Aug 15;48(4):276-86. doi: 10.1016/s0006-3223(00)00236-5.

Maurage P, Campanella S, Philippot P, de Timary P, Constant E, Gauthier S, Micciche ML, Kornreich C, Hanak C, Noel X, Verbanck P. Alcoholism leads to early perceptive alterations, independently of comorbid depressed state: an ERP study. Neurophysiol Clin. 2008 Apr;38(2):83-97. doi: 10.1016/j.neucli.2008.02.001. Epub 2008 Mar 3.

Gilmore CS, Fein G. Theta event-related synchronization is a biomarker for a morbid effect of alcoholism on the brain that may partially resolve with extended abstinence. Brain Behav. 2012 Nov;2(6):796-805. doi: 10.1002/brb3.95. Epub 2012 Oct 5.

Boeijinga PH, Parot P, Soufflet L, Landron F, Danel T, Gendre I, Muzet M, Demazieres A, Luthringer R. Pharmacodynamic effects of acamprosate on markers of cerebral function in alcohol-dependent subjects administered as pretreatment and during alcohol abstinence. Neuropsychobiology. 2004;50(1):71-7. doi: 10.1159/000077944.

Bauer LO, Hesselbrock VM. Brain maturation and subtypes of conduct disorder: interactive effects on p300 amplitude and topography in male adolescents. J Am Acad Child Adolesc Psychiatry. 2003 Jan;42(1):106-15. doi: 10.1097/00004583-200301000-00017.

HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

Higley AE, Crane NA, Spadoni AD, Quello SB, Goodell V, Mason BJ. Craving in response to stress induction in a human laboratory paradigm predicts treatment outcome in alcohol-dependent individuals. Psychopharmacology (Berl). 2011 Nov;218(1):121-9. doi: 10.1007/s00213-011-2355-8. Epub 2011 May 24.

Pietrzak B, Czarnecka E. Effect of the combined administration of ethanol and acamprosate on rabbit EEG. Pharmacol Rep. 2005 Jan-Feb;57(1):61-9.

Staner L, Boeijinga P, Danel T, Gendre I, Muzet M, Landron F, Luthringer R. Effects of acamprosate on sleep during alcohol withdrawal: A double-blind placebo-controlled polysomnographic study in alcohol-dependent subjects. Alcohol Clin Exp Res. 2006 Sep;30(9):1492-9. doi: 10.1111/j.1530-0277.2006.00180.x.