Effect of N-acetylcysteine on Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
NCT ID: NCT03018236
Last Updated: 2017-01-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-01-31
Study Completion Date
2018-12-31
Brief Summary
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This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use disorders. Alcohol users will be split in two groups, one will receive the active N-acetylcysteine and the other placebo. The same division will occur with cocaine users. The effects of N-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress biomarkers will be evaluated.
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Detailed Description
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N-acetylcysteine acts replenishing the human body glutathione storages. Glutathione is an important antioxidant agent, and also modulates the N-methyl-D-aspartate (NMDA) glutamatergic receptor. Glutamate has been associated with the neuroadaptation related to substance use disorders, and thus it is considered a potential target for pharmacological interventions regarding these disorders. N-acetylcysteine also interacts with the cystine-glutamate antiporter on astrocytes hence increasing glutamate release into the extracellular space.
N-acetylcysteine effects and its implications in the addiction disorders have been studied initially with animal models. Glutamate levels normalization through N-acetylcysteine reduced compulsive drug self-administration and drug-seeking behavior in mice. In addition, there are promising results also with human subjects, showing benefits for cocaine, alcohol and cannabis use disorders.
This study consists of a randomized, double-blind, placebo controlled trial with four arms: alcohol users divided into NAC vs Placebo and cocaine users divided into NAC vs Placebo.
N-acetylcysteine effects and its implications in the addiction disorders have been studied initially with animal models. Glutamate levels normalization through N-acetylcysteine reduced compulsive drug self-administration and drug-seeking behavior in mice. In addition, there are promising results also with human subjects, showing benefits for cocaine, alcohol and cannabis use disorders.
This study consists of a randomized, double-blind, placebo controlled trial with four arms: alcohol users divided into NAC vs Placebo and cocaine users divided into NAC vs Placebo.
Conditions
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Cocaine Addiction
Alcohol Addiction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Alcohol N-acetylcysteine
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
Group Type
EXPERIMENTAL
Alcohol N-acetylcysteine
Intervention Type
DRUG
1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
Alcohol Placebo
A placebo capsule matching color and smell of the active medication
Group Type
PLACEBO_COMPARATOR
Alcohol Placebo
Intervention Type
DRUG
Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
Cocaine N-acetylcysteine
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
Group Type
EXPERIMENTAL
Cocaine N-acetylcysteine
Intervention Type
DRUG
1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
Cocaine Placebo
A placebo capsule matching color and smell of the active medication
Group Type
PLACEBO_COMPARATOR
Cocaine Placebo
Intervention Type
DRUG
Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder
Interventions
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Alcohol N-acetylcysteine
1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
Intervention Type
DRUG
Alcohol Placebo
Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
Intervention Type
DRUG
Cocaine N-acetylcysteine
1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
Intervention Type
DRUG
Cocaine Placebo
Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder
Intervention Type
DRUG
Other Intervention Names
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NAC
NAC
Eligibility Criteria
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Inclusion Criteria
* Diagnostic of Alcohol or Cocaine Use Disorder
* Seven days of inpatient treatment in an addiction treatment specialized unit
* Seven days of inpatient treatment in an addiction treatment specialized unit
Exclusion Criteria
* Another Substance Use Disorder (exception: tobacco)
* Severe medical conditions (cardiac, renal or hepatic), that preclude subject participation
* History of asthma or convulsions medication use
* Recent use (\<14 days) of any medication that could interfere with the study medication
* History of anaphylactic reactions with the study medication
* Suicide risk
* Inability to understand the informed consent form or to comply with the study requirements
* Any severe neuropsychiatric condition, not caused by the substance use, that requires specific medication treatments and could interfere with the study development, in the investigators opinion (for instance: dementia, schizophrenia or other psychoses, multiple sclerosis, severe depression, stroke, epilepsy, bipolar disorder)
* Failing to complete the screening procedures prior to the study first week
* Severe medical conditions (cardiac, renal or hepatic), that preclude subject participation
* History of asthma or convulsions medication use
* Recent use (\<14 days) of any medication that could interfere with the study medication
* History of anaphylactic reactions with the study medication
* Suicide risk
* Inability to understand the informed consent form or to comply with the study requirements
* Any severe neuropsychiatric condition, not caused by the substance use, that requires specific medication treatments and could interfere with the study development, in the investigators opinion (for instance: dementia, schizophrenia or other psychoses, multiple sclerosis, severe depression, stroke, epilepsy, bipolar disorder)
* Failing to complete the screening procedures prior to the study first week
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Secretaria Nacional de Políticas sobre Drogas (SENAD)
UNKNOWN
Sponsor Role
collaborator
Hospital de Clinicas de Porto Alegre
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Lisia von Diemen, PhD
Role: STUDY_CHAIR
Federal University of Rio Grande do Sul (UFRGS)
Flavio Pechansky, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Rio Grande do Sul (UFRGS)
Locations
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Hospital de Clinicas de Porto Alegre - Unidade Alvaro Alvim
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
RECRUITING
Countries
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Brazil
Central Contacts
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Facility Contacts
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References
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Agrawal A, Verweij KJ, Gillespie NA, Heath AC, Lessov-Schlaggar CN, Martin NG, Nelson EC, Slutske WS, Whitfield JB, Lynskey MT. The genetics of addiction-a translational perspective. Transl Psychiatry. 2012 Jul 17;2(7):e140. doi: 10.1038/tp.2012.54.
Reference Type
BACKGROUND
Andreazza AC, Frey BN, Valvassori SS, Zanotto C, Gomes KM, Comim CM, Cassini C, Stertz L, Ribeiro LC, Quevedo J, Kapczinski F, Berk M, Goncalves CA. DNA damage in rats after treatment with methylphenidate. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Aug 15;31(6):1282-8. doi: 10.1016/j.pnpbp.2007.05.012. Epub 2007 Jun 2.
Reference Type
BACKGROUND
Baan R, Straif K, Grosse Y, Secretan B, El Ghissassi F, Bouvard V, Altieri A, Cogliano V; WHO International Agency for Research on Cancer Monograph Working Group. Carcinogenicity of alcoholic beverages. Lancet Oncol. 2007 Apr;8(4):292-3. doi: 10.1016/s1470-2045(07)70099-2. No abstract available.
Reference Type
BACKGROUND
Baker DA, McFarland K, Lake RW, Shen H, Toda S, Kalivas PW. N-acetyl cysteine-induced blockade of cocaine-induced reinstatement. Ann N Y Acad Sci. 2003 Nov;1003:349-51. doi: 10.1196/annals.1300.023. No abstract available.
Reference Type
BACKGROUND
Berk M, Malhi GS, Gray LJ, Dean OM. The promise of N-acetylcysteine in neuropsychiatry. Trends Pharmacol Sci. 2013 Mar;34(3):167-77. doi: 10.1016/j.tips.2013.01.001. Epub 2013 Jan 29.
Reference Type
BACKGROUND
Bibel M, Barde YA. Neurotrophins: key regulators of cell fate and cell shape in the vertebrate nervous system. Genes Dev. 2000 Dec 1;14(23):2919-37. doi: 10.1101/gad.841400. No abstract available.
Reference Type
BACKGROUND
Calado RT, Young NS. Telomere diseases. N Engl J Med. 2009 Dec 10;361(24):2353-65. doi: 10.1056/NEJMra0903373. No abstract available.
Reference Type
BACKGROUND
Chen CH, Pan CH, Chen CC, Huang MC. Increased oxidative DNA damage in patients with alcohol dependence and its correlation with alcohol withdrawal severity. Alcohol Clin Exp Res. 2011 Feb;35(2):338-44. doi: 10.1111/j.1530-0277.2010.01349.x. Epub 2010 Nov 10.
Reference Type
BACKGROUND
Corominas-Roso M, Roncero C, Daigre C, Grau-Lopez L, Ros-Cucurull E, Rodriguez-Cintas L, Sanchez-Mora C, Lopez MV, Ribases M, Casas M. Changes in brain-derived neurotrophic factor (BDNF) during abstinence could be associated with relapse in cocaine-dependent patients. Psychiatry Res. 2015 Feb 28;225(3):309-14. doi: 10.1016/j.psychres.2014.12.019. Epub 2014 Dec 20.
Reference Type
BACKGROUND
Costa MA, Girard M, Dalmay F, Malauzat D. Brain-derived neurotrophic factor serum levels in alcohol-dependent subjects 6 months after alcohol withdrawal. Alcohol Clin Exp Res. 2011 Nov;35(11):1966-73. doi: 10.1111/j.1530-0277.2011.01548.x. Epub 2011 Aug 16.
Reference Type
BACKGROUND
Cross CE, Valacchi G, Schock B, Wilson M, Weber S, Eiserich J, van der Vliet A. Environmental oxidant pollutant effects on biologic systems: a focus on micronutrient antioxidant-oxidant interactions. Am J Respir Crit Care Med. 2002 Dec 15;166(12 Pt 2):S44-50. doi: 10.1164/rccm.2206015.
Reference Type
BACKGROUND
Davis MI. Ethanol-BDNF interactions: still more questions than answers. Pharmacol Ther. 2008 Apr;118(1):36-57. doi: 10.1016/j.pharmthera.2008.01.003. Epub 2008 Feb 2.
Reference Type
BACKGROUND
Dean O, Giorlando F, Berk M. N-acetylcysteine in psychiatry: current therapeutic evidence and potential mechanisms of action. J Psychiatry Neurosci. 2011 Mar;36(2):78-86. doi: 10.1503/jpn.100057.
Reference Type
BACKGROUND
Degenhardt L, Singleton J, Calabria B, McLaren J, Kerr T, Mehta S, Kirk G, Hall WD. Mortality among cocaine users: a systematic review of cohort studies. Drug Alcohol Depend. 2011 Jan 15;113(2-3):88-95. doi: 10.1016/j.drugalcdep.2010.07.026. Epub 2010 Sep 15.
Reference Type
BACKGROUND
Ersche KD, Jones PS, Williams GB, Robbins TW, Bullmore ET. Cocaine dependence: a fast-track for brain ageing? Mol Psychiatry. 2013 Feb;18(2):134-5. doi: 10.1038/mp.2012.31. Epub 2012 Apr 24. No abstract available.
Reference Type
BACKGROUND
Frey BN, Valvassori SS, Gomes KM, Martins MR, Dal-Pizzol F, Kapczinski F, Quevedo J. Increased oxidative stress in submitochondrial particles after chronic amphetamine exposure. Brain Res. 2006 Jun 30;1097(1):224-9. doi: 10.1016/j.brainres.2006.04.076. Epub 2006 May 30.
Reference Type
BACKGROUND
Garbutt JC, Greenblatt AM, West SL, Morgan LC, Kampov-Polevoy A, Jordan HS, Bobashev GV. Clinical and biological moderators of response to naltrexone in alcohol dependence: a systematic review of the evidence. Addiction. 2014 Aug;109(8):1274-84. doi: 10.1111/add.12557. Epub 2014 May 23.
Reference Type
BACKGROUND
Grant JE, Odlaug BL, Kim SW. A double-blind, placebo-controlled study of N-acetyl cysteine plus naltrexone for methamphetamine dependence. Eur Neuropsychopharmacol. 2010 Nov;20(11):823-8. doi: 10.1016/j.euroneuro.2010.06.018. Epub 2010 Jul 22.
Reference Type
BACKGROUND
Gray KM, Carpenter MJ, Baker NL, DeSantis SM, Kryway E, Hartwell KJ, McRae-Clark AL, Brady KT. A double-blind randomized controlled trial of N-acetylcysteine in cannabis-dependent adolescents. Am J Psychiatry. 2012 Aug;169(8):805-12. doi: 10.1176/appi.ajp.2012.12010055.
Reference Type
BACKGROUND
Gray KM, Watson NL, Carpenter MJ, Larowe SD. N-acetylcysteine (NAC) in young marijuana users: an open-label pilot study. Am J Addict. 2010 Mar-Apr;19(2):187-9. doi: 10.1111/j.1521-0391.2009.00027.x. No abstract available.
Reference Type
BACKGROUND
Griffith JD, Rowan-Szal GA, Roark RR, Simpson DD. Contingency management in outpatient methadone treatment: a meta-analysis. Drug Alcohol Depend. 2000 Feb 1;58(1-2):55-66. doi: 10.1016/s0376-8716(99)00068-x.
Reference Type
BACKGROUND
Haile CN, Kosten TR, Kosten TA. Genetics of dopamine and its contribution to cocaine addiction. Behav Genet. 2007 Jan;37(1):119-45. doi: 10.1007/s10519-006-9115-2. Epub 2006 Oct 25.
Reference Type
BACKGROUND
Huang MC, Chen CC, Peng FC, Tang SH, Chen CH. The correlation between early alcohol withdrawal severity and oxidative stress in patients with alcohol dependence. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Feb 1;33(1):66-9. doi: 10.1016/j.pnpbp.2008.10.009. Epub 2008 Oct 27.
Reference Type
BACKGROUND
Huang MC, Chen CH, Liu HC, Chen CC, Ho CC, Leu SJ. Differential patterns of serum brain-derived neurotrophic factor levels in alcoholic patients with and without delirium tremens during acute withdrawal. Alcohol Clin Exp Res. 2011 Jan;35(1):126-31. doi: 10.1111/j.1530-0277.2010.01329.x. Epub 2010 Oct 6.
Reference Type
BACKGROUND
Huang MC, Chen CH, Chen CH, Liu SC, Ho CJ, Shen WW, Leu SJ. Alterations of serum brain-derived neurotrophic factor levels in early alcohol withdrawal. Alcohol Alcohol. 2008 May-Jun;43(3):241-5. doi: 10.1093/alcalc/agm172. Epub 2008 Mar 7.
Reference Type
BACKGROUND
Jaffe JH. Trivializing dependence. Br J Addict. 1990 Nov;85(11):1425-7; discussion 1429-31. doi: 10.1111/j.1360-0443.1990.tb01624.x.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Kampman KM, Volpicelli JR, McGinnis DE, Alterman AI, Weinrieb RM, D'Angelo L, Epperson LE. Reliability and validity of the Cocaine Selective Severity Assessment. Addict Behav. 1998 Jul-Aug;23(4):449-61. doi: 10.1016/s0306-4603(98)00011-2.
Reference Type
BACKGROUND
Kendler KS, Ohlsson H, Maes HH, Sundquist K, Lichtenstein P, Sundquist J. A population-based Swedish Twin and Sibling Study of cannabis, stimulant and sedative abuse in men. Drug Alcohol Depend. 2015 Apr 1;149:49-54. doi: 10.1016/j.drugalcdep.2015.01.016. Epub 2015 Jan 28.
Reference Type
BACKGROUND
Kenward MG. Selection models for repeated measurements with non-random dropout: an illustration of sensitivity. Stat Med. 1998 Dec 15;17(23):2723-32. doi: 10.1002/(sici)1097-0258(19981215)17:233.0.co;2-5.
Reference Type
BACKGROUND
Kessler F, Cacciola J, Alterman A, Faller S, Souza-Formigoni ML, Cruz MS, Brasiliano S, Pechansky F. Psychometric properties of the sixth version of the Addiction Severity Index (ASI-6) in Brazil. Braz J Psychiatry. 2012 Mar;34(1):24-33. doi: 10.1590/s1516-44462012000100006.
Reference Type
BACKGROUND
Laird NM. Missing data in longitudinal studies. Stat Med. 1988 Jan-Feb;7(1-2):305-15. doi: 10.1002/sim.4780070131.
Reference Type
BACKGROUND
LaRowe SD, Mardikian P, Malcolm R, Myrick H, Kalivas P, McFarland K, Saladin M, McRae A, Brady K. Safety and tolerability of N-acetylcysteine in cocaine-dependent individuals. Am J Addict. 2006 Jan-Feb;15(1):105-10. doi: 10.1080/10550490500419169.
Reference Type
BACKGROUND
LaRowe SD, Myrick H, Hedden S, Mardikian P, Saladin M, McRae A, Brady K, Kalivas PW, Malcolm R. Is cocaine desire reduced by N-acetylcysteine? Am J Psychiatry. 2007 Jul;164(7):1115-7. doi: 10.1176/ajp.2007.164.7.1115.
Reference Type
BACKGROUND
Lussier JP, Heil SH, Mongeon JA, Badger GJ, Higgins ST. A meta-analysis of voucher-based reinforcement therapy for substance use disorders. Addiction. 2006 Feb;101(2):192-203. doi: 10.1111/j.1360-0443.2006.01311.x.
Reference Type
BACKGROUND
Lynskey MT, Agrawal A, Henders A, Nelson EC, Madden PA, Martin NG. An Australian twin study of cannabis and other illicit drug use and misuse, and other psychopathology. Twin Res Hum Genet. 2012 Oct;15(5):631-41. doi: 10.1017/thg.2012.41. Epub 2012 Jul 9.
Reference Type
BACKGROUND
Mardikian PN, LaRowe SD, Hedden S, Kalivas PW, Malcolm RJ. An open-label trial of N-acetylcysteine for the treatment of cocaine dependence: a pilot study. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Mar 30;31(2):389-94. doi: 10.1016/j.pnpbp.2006.10.001. Epub 2006 Nov 17.
Reference Type
BACKGROUND
McGinty JF, Mendelson JE. Is brain-derived neurotrophic factor a selective biomarker that predicts cocaine relapse outcomes? Biol Psychiatry. 2011 Oct 15;70(8):700-701. doi: 10.1016/j.biopsych.2011.08.017. No abstract available.
Reference Type
BACKGROUND
McGinty JF, Whitfield TW Jr, Berglind WJ. Brain-derived neurotrophic factor and cocaine addiction. Brain Res. 2010 Feb 16;1314:183-93. doi: 10.1016/j.brainres.2009.08.078. Epub 2009 Sep 2.
Reference Type
BACKGROUND
McLellan AT, Alterman AI, Cacciola J, Metzger D, O'Brien CP. A new measure of substance abuse treatment. Initial studies of the treatment services review. J Nerv Ment Dis. 1992 Feb;180(2):101-10. doi: 10.1097/00005053-199202000-00007.
Reference Type
BACKGROUND
McLellan AT, Kushner H, Metzger D, Peters R, Smith I, Grissom G, Pettinati H, Argeriou M. The Fifth Edition of the Addiction Severity Index. J Subst Abuse Treat. 1992;9(3):199-213. doi: 10.1016/0740-5472(92)90062-s.
Reference Type
BACKGROUND
Nestler EJ. From neurobiology to treatment: progress against addiction. Nat Neurosci. 2002 Nov;5 Suppl:1076-9. doi: 10.1038/nn945.
Reference Type
BACKGROUND
Nestler EJ. The neurobiology of cocaine addiction. Sci Pract Perspect. 2005 Dec;3(1):4-10. doi: 10.1151/spp05314.
Reference Type
BACKGROUND
Olive MF, Cleva RM, Kalivas PW, Malcolm RJ. Glutamatergic medications for the treatment of drug and behavioral addictions. Pharmacol Biochem Behav. 2012 Feb;100(4):801-10. doi: 10.1016/j.pbb.2011.04.015. Epub 2011 Apr 22.
Reference Type
BACKGROUND
de Lima Osorio F, Crippa JA, Loureiro SR. Further psychometric study of the Beck Anxiety Inventory including factorial analysis and social anxiety disorder screening. Int J Psychiatry Clin Pract. 2011 Nov;15(4):255-62. doi: 10.3109/13651501.2011.605955.
Reference Type
BACKGROUND
Patriquin MA, Bauer IE, Soares JC, Graham DP, Nielsen DA. Addiction pharmacogenetics: a systematic review of the genetic variation of the dopaminergic system. Psychiatr Genet. 2015 Oct;25(5):181-93. doi: 10.1097/YPG.0000000000000095.
Reference Type
BACKGROUND
Pavanello S, Hoxha M, Dioni L, Bertazzi PA, Snenghi R, Nalesso A, Ferrara SD, Montisci M, Baccarelli A. Shortened telomeres in individuals with abuse in alcohol consumption. Int J Cancer. 2011 Aug 15;129(4):983-92. doi: 10.1002/ijc.25999. Epub 2011 Apr 25.
Reference Type
BACKGROUND
Prendergast M, Podus D, Finney J, Greenwell L, Roll J. Contingency management for treatment of substance use disorders: a meta-analysis. Addiction. 2006 Nov;101(11):1546-60. doi: 10.1111/j.1360-0443.2006.01581.x.
Reference Type
BACKGROUND
Rabkin JG, Markowitz JS, Ocepek-Welikson K, Wager SS. General versus systematic inquiry about emergent clinical events with SAFTEE: implications for clinical research. J Clin Psychopharmacol. 1992 Feb;12(1):3-10. doi: 10.1097/00001573-199202000-00002.
Reference Type
BACKGROUND
Rosa AR, Sanchez-Moreno J, Martinez-Aran A, Salamero M, Torrent C, Reinares M, Comes M, Colom F, Van Riel W, Ayuso-Mateos JL, Kapczinski F, Vieta E. Validity and reliability of the Functioning Assessment Short Test (FAST) in bipolar disorder. Clin Pract Epidemiol Ment Health. 2007 Jun 7;3:5. doi: 10.1186/1745-0179-3-5.
Reference Type
BACKGROUND
Sansone RA, Sansone LA. Getting a Knack for NAC: N-Acetyl-Cysteine. Innov Clin Neurosci. 2011 Jan;8(1):10-4.
Reference Type
BACKGROUND
Santos Cruz M, Andrade T, Bastos FI, Leal E, Bertoni N, Villar LM, Tiesmaki M, Fischer B. Key drug use, health and socio-economic characteristics of young crack users in two Brazilian cities. Int J Drug Policy. 2013 Sep;24(5):432-8. doi: 10.1016/j.drugpo.2013.03.012. Epub 2013 Apr 28.
Reference Type
BACKGROUND
Schmaal L, Berk L, Hulstijn KP, Cousijn J, Wiers RW, van den Brink W. Efficacy of N-acetylcysteine in the treatment of nicotine dependence: a double-blind placebo-controlled pilot study. Eur Addict Res. 2011;17(4):211-6. doi: 10.1159/000327682. Epub 2011 May 24.
Reference Type
BACKGROUND
Schmaal L, Veltman DJ, Nederveen A, van den Brink W, Goudriaan AE. N-acetylcysteine normalizes glutamate levels in cocaine-dependent patients: a randomized crossover magnetic resonance spectroscopy study. Neuropsychopharmacology. 2012 Aug;37(9):2143-52. doi: 10.1038/npp.2012.66. Epub 2012 May 2.
Reference Type
BACKGROUND
Schneider R Jr, Santos CF, Clarimundo V, Dalmaz C, Elisabetsky E, Gomez R. N-acetylcysteine prevents behavioral and biochemical changes induced by alcohol cessation in rats. Alcohol. 2015 May;49(3):259-63. doi: 10.1016/j.alcohol.2015.01.009. Epub 2015 Feb 13.
Reference Type
BACKGROUND
Shen Q, Zhao X, Yu L, Zhang Z, Zhou D, Kan M, Zhang D, Cao L, Xing Q, Yang Y, Xu H, He L, Liu Y. Association of leukocyte telomere length with type 2 diabetes in mainland Chinese populations. J Clin Endocrinol Metab. 2012 Apr;97(4):1371-4. doi: 10.1210/jc.2011-1562. Epub 2012 Feb 8.
Reference Type
BACKGROUND
Sinha R. New findings on biological factors predicting addiction relapse vulnerability. Curr Psychiatry Rep. 2011 Oct;13(5):398-405. doi: 10.1007/s11920-011-0224-0.
Reference Type
BACKGROUND
Skinner MD, Lahmek P, Pham H, Aubin HJ. Disulfiram efficacy in the treatment of alcohol dependence: a meta-analysis. PLoS One. 2014 Feb 10;9(2):e87366. doi: 10.1371/journal.pone.0087366. eCollection 2014.
Reference Type
BACKGROUND
Sordi AO, Pechansky F, Kessler FH, Kapczinski F, Pfaffenseller B, Gubert C, de Aguiar BW, de Magalhaes Narvaez JC, Ornell F, von Diemen L. Oxidative stress and BDNF as possible markers for the severity of crack cocaine use in early withdrawal. Psychopharmacology (Berl). 2014 Oct;231(20):4031-9. doi: 10.1007/s00213-014-3542-1. Epub 2014 Mar 28.
Reference Type
BACKGROUND
Spencer RL, Hutchison KE. Alcohol, aging, and the stress response. Alcohol Res Health. 1999;23(4):272-83.
Reference Type
BACKGROUND
Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
Reference Type
BACKGROUND
Urbanska EM, Czuczwar SJ, Kleinrok Z, Turski WA. Excitatory amino acids in epilepsy. Restor Neurol Neurosci. 1998;13(1-2):25-39.
Reference Type
BACKGROUND
Verdejo-Garcia A, Perez-Garcia M. Profile of executive deficits in cocaine and heroin polysubstance users: common and differential effects on separate executive components. Psychopharmacology (Berl). 2007 Mar;190(4):517-30. doi: 10.1007/s00213-006-0632-8. Epub 2006 Nov 29.
Reference Type
BACKGROUND
Volkow ND, Koob G, Baler R. Biomarkers in substance use disorders. ACS Chem Neurosci. 2015 Apr 15;6(4):522-5. doi: 10.1021/acschemneuro.5b00067. Epub 2015 Mar 18.
Reference Type
BACKGROUND
von Diemen L, Kapczinski F, Sordi AO, de Magalhaes Narvaez JC, Guimaraes LS, Kessler FH, Pfaffenseller B, de Aguiar BW, de Moura Gubert C, Pechansky F. Increase in brain-derived neurotrophic factor expression in early crack cocaine withdrawal. Int J Neuropsychopharmacol. 2014 Jan;17(1):33-40. doi: 10.1017/S146114571300103X. Epub 2013 Sep 26.
Reference Type
BACKGROUND
Walker J, Winhusen T, Storkson JM, Lewis D, Pariza MW, Somoza E, Somoza V. Total antioxidant capacity is significantly lower in cocaine-dependent and methamphetamine-dependent patients relative to normal controls: results from a preliminary study. Hum Psychopharmacol. 2014 Nov;29(6):537-43. doi: 10.1002/hup.2430.
Reference Type
BACKGROUND
Wei LJ, Lachin JM. Properties of the urn randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):345-64. doi: 10.1016/0197-2456(88)90048-7.
Reference Type
BACKGROUND
Wu Y, Pan X, Zhang S, Wang W, Cai M, Li Y, Yang F, Guo H. Protective effect of corn peptides against alcoholic liver injury in men with chronic alcohol consumption: a randomized double-blind placebo-controlled study. Lipids Health Dis. 2014 Dec 13;13:192. doi: 10.1186/1476-511X-13-192.
Reference Type
BACKGROUND
Yang Z, Ye J, Li C, Zhou D, Shen Q, Wu J, Cao L, Wang T, Cui D, He S, Qi G, He L, Liu Y. Drug addiction is associated with leukocyte telomere length. Sci Rep. 2013;3:1542. doi: 10.1038/srep01542.
Reference Type
BACKGROUND
Zaparte A, Viola TW, Grassi-Oliveira R, da Silva Morrone M, Moreira JC, Bauer ME. Early abstinence of crack-cocaine is effective to attenuate oxidative stress and to improve antioxidant defences. Psychopharmacology (Berl). 2015 Apr;232(8):1405-13. doi: 10.1007/s00213-014-3779-8. Epub 2014 Oct 23.
Reference Type
BACKGROUND
Zhou W, Kalivas PW. N-acetylcysteine reduces extinction responding and induces enduring reductions in cue- and heroin-induced drug-seeking. Biol Psychiatry. 2008 Feb 1;63(3):338-40. doi: 10.1016/j.biopsych.2007.06.008. Epub 2007 Aug 24.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
150488
Identifier Type: -
Identifier Source: org_study_id
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