search
Back to results

Effect of N-acetylcysteine on Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.

Primary Purpose

Cocaine Addiction, Alcohol Addiction

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Alcohol N-acetylcysteine
Alcohol Placebo
Cocaine N-acetylcysteine
Cocaine Placebo
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Addiction focused on measuring cocaine, alcohol, substance use disorders, addiction, N-acetylcysteine, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnostic of Alcohol or Cocaine Use Disorder
  • 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

Sites / Locations

  • Hospital de Clinicas de Porto Alegre - Unidade Alvaro AlvimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Alcohol N-acetylcysteine

Alcohol Placebo

Cocaine N-acetylcysteine

Cocaine Placebo

Arm Description

600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks

A placebo capsule matching color and smell of the active medication

600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks

A placebo capsule matching color and smell of the active medication

Outcomes

Primary Outcome Measures

Number of participants who attended all study appointments
Completers (i.e. subjects who attended all study appointments) vs non-completers

Secondary Outcome Measures

Abstinence by urine
Amount of positive urine tests for cocaine users
Abstinence by breathalyzer
Amount of positive breathalyzer tests for alcohol users
Abstinence by self report
Timeline Followback Method
Days of inpatient treatment
The difference (if any) between placebo and intervention groups in the amount of inpatient treatment days.
Change in scores of CGI
Differences in scores of the Clinical Global Impression (CGI)
Change in scores of FAST
Differences in scores of the Functioning Assessment Short Test (FAST).
Depressive symptoms
Differences in scores of the Beck Depression Inventory (BDI)
Anxiety symptoms
Differences in scores of the Beck Anxiety Inventory (BAI)
BDNF
Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF)
GSSG
Differences between groups regarding dosage of Oxidized Glutathione (GSSG)
GSH
Differences between groups regarding dosage of Glutathione (GSH)
GPx
Differences between groups regarding dosage of Glutathione Peroxidase (GPx)
CAT
Differences between groups regarding dosage of Catalase (CAT)
TBARS
Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS)
SOD
Differences between groups regarding dosage of Superoxide Dismutase (SOD)
Carbonyl
Differences between groups regarding dosage of Carbonyl

Full Information

First Posted
January 10, 2017
Last Updated
January 20, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Secretaria Nacional de Políticas sobre Drogas (SENAD)
search

1. Study Identification

Unique Protocol Identification Number
NCT03018236
Brief Title
Effect of N-acetylcysteine on Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
Official Title
The Effect of N-acetylcysteine (NAC) on Treatment of Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Secretaria Nacional de Políticas sobre Drogas (SENAD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction, Alcohol Addiction
Keywords
cocaine, alcohol, substance use disorders, addiction, N-acetylcysteine, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol N-acetylcysteine
Arm Type
Experimental
Arm Description
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
Arm Title
Alcohol Placebo
Arm Type
Placebo Comparator
Arm Description
A placebo capsule matching color and smell of the active medication
Arm Title
Cocaine N-acetylcysteine
Arm Type
Experimental
Arm Description
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
Arm Title
Cocaine Placebo
Arm Type
Placebo Comparator
Arm Description
A placebo capsule matching color and smell of the active medication
Intervention Type
Drug
Intervention Name(s)
Alcohol N-acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
Intervention Type
Drug
Intervention Name(s)
Alcohol Placebo
Intervention Description
Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
Intervention Type
Drug
Intervention Name(s)
Cocaine N-acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
Intervention Type
Drug
Intervention Name(s)
Cocaine Placebo
Intervention Description
Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder
Primary Outcome Measure Information:
Title
Number of participants who attended all study appointments
Description
Completers (i.e. subjects who attended all study appointments) vs non-completers
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Abstinence by urine
Description
Amount of positive urine tests for cocaine users
Time Frame
8 weeks
Title
Abstinence by breathalyzer
Description
Amount of positive breathalyzer tests for alcohol users
Time Frame
8 weeks
Title
Abstinence by self report
Description
Timeline Followback Method
Time Frame
8 weeks
Title
Days of inpatient treatment
Description
The difference (if any) between placebo and intervention groups in the amount of inpatient treatment days.
Time Frame
Up to 4 weeks
Title
Change in scores of CGI
Description
Differences in scores of the Clinical Global Impression (CGI)
Time Frame
8 weeks
Title
Change in scores of FAST
Description
Differences in scores of the Functioning Assessment Short Test (FAST).
Time Frame
8 weeks
Title
Depressive symptoms
Description
Differences in scores of the Beck Depression Inventory (BDI)
Time Frame
8 weeks
Title
Anxiety symptoms
Description
Differences in scores of the Beck Anxiety Inventory (BAI)
Time Frame
8 weeks
Title
BDNF
Description
Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF)
Time Frame
8 weeks
Title
GSSG
Description
Differences between groups regarding dosage of Oxidized Glutathione (GSSG)
Time Frame
8 weeks
Title
GSH
Description
Differences between groups regarding dosage of Glutathione (GSH)
Time Frame
8 weeks
Title
GPx
Description
Differences between groups regarding dosage of Glutathione Peroxidase (GPx)
Time Frame
8 weeks
Title
CAT
Description
Differences between groups regarding dosage of Catalase (CAT)
Time Frame
8 weeks
Title
TBARS
Description
Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS)
Time Frame
8 weeks
Title
SOD
Description
Differences between groups regarding dosage of Superoxide Dismutase (SOD)
Time Frame
8 weeks
Title
Carbonyl
Description
Differences between groups regarding dosage of Carbonyl
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Systematic Assessment for Treatment Emergent Events (SAFTEE) application
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnostic of Alcohol or Cocaine Use Disorder 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisia von Diemen, PhD
Phone
+55 51 3359 6471
Email
lisiavd@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thiago C Hartmann, MsC
Phone
+55 51 3359 6476
Email
hartmann321@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisia von Diemen, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul (UFRGS)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Flavio Pechansky, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul (UFRGS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre - Unidade Alvaro Alvim
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90420-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiago C Hartmann, MsC
Phone
+55 51 3359 6476
Email
hartmann321@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22806211
Citation
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. Erratum In: Transl Psychiatry. 2012;2:e193.
Results Reference
background
PubMed Identifier
17614179
Citation
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.
Results Reference
background
PubMed Identifier
17431955
Citation
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.
Results Reference
background
PubMed Identifier
14684458
Citation
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.
Results Reference
background
PubMed Identifier
23369637
Citation
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.
Results Reference
background
PubMed Identifier
11114882
Citation
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.
Results Reference
background
PubMed Identifier
20007561
Citation
Calado RT, Young NS. Telomere diseases. N Engl J Med. 2009 Dec 10;361(24):2353-65. doi: 10.1056/NEJMra0903373. No abstract available.
Results Reference
background
PubMed Identifier
21070251
Citation
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.
Results Reference
background
PubMed Identifier
25592977
Citation
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.
Results Reference
background
PubMed Identifier
21848960
Citation
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.
Results Reference
background
PubMed Identifier
12471088
Citation
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.
Results Reference
background
PubMed Identifier
18394710
Citation
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.
Results Reference
background
PubMed Identifier
21118657
Citation
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.
Results Reference
background
PubMed Identifier
20828942
Citation
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.
Results Reference
background
PubMed Identifier
22525488
Citation
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.
Results Reference
background
PubMed Identifier
16730669
Citation
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.
Results Reference
background
PubMed Identifier
24661324
Citation
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.
Results Reference
background
PubMed Identifier
20655182
Citation
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.
Results Reference
background
PubMed Identifier
22706327
Citation
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. Erratum In: Am J Psychiatry. 2012 Aug 1;169(8):869.
Results Reference
background
PubMed Identifier
20163391
Citation
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.
Results Reference
background
PubMed Identifier
10669055
Citation
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.
Results Reference
background
PubMed Identifier
17063402
Citation
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.
Results Reference
background
PubMed Identifier
18996163
Citation
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.
Results Reference
background
PubMed Identifier
21039634
Citation
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.
Results Reference
background
PubMed Identifier
18326550
Citation
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.
Results Reference
background
PubMed Identifier
2285838
Citation
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.
Results Reference
background
PubMed Identifier
24825644
Citation
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.
Results Reference
background
PubMed Identifier
9698974
Citation
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.
Results Reference
background
PubMed Identifier
25660314
Citation
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.
Results Reference
background
PubMed Identifier
9881418
Citation
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.
Results Reference
background
PubMed Identifier
22392385
Citation
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.
Results Reference
background
PubMed Identifier
3353609
Citation
Laird NM. Missing data in longitudinal studies. Stat Med. 1988 Jan-Feb;7(1-2):305-15. doi: 10.1002/sim.4780070131.
Results Reference
background
PubMed Identifier
16449100
Citation
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.
Results Reference
background
PubMed Identifier
17606664
Citation
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.
Results Reference
background
PubMed Identifier
16445548
Citation
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.
Results Reference
background
PubMed Identifier
22874079
Citation
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.
Results Reference
background
PubMed Identifier
17113207
Citation
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.
Results Reference
background
PubMed Identifier
21967984
Citation
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.
Results Reference
background
PubMed Identifier
19732758
Citation
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.
Results Reference
background
PubMed Identifier
1737971
Citation
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.
Results Reference
background
PubMed Identifier
1334156
Citation
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.
Results Reference
background
PubMed Identifier
12403990
Citation
Nestler EJ. From neurobiology to treatment: progress against addiction. Nat Neurosci. 2002 Nov;5 Suppl:1076-9. doi: 10.1038/nn945.
Results Reference
background
PubMed Identifier
18552739
Citation
Nestler EJ. The neurobiology of cocaine addiction. Sci Pract Perspect. 2005 Dec;3(1):4-10. doi: 10.1151/spp05314.
Results Reference
background
PubMed Identifier
21536062
Citation
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.
Results Reference
background
PubMed Identifier
22121998
Citation
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.
Results Reference
background
PubMed Identifier
26146874
Citation
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.
Results Reference
background
PubMed Identifier
21351086
Citation
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.
Results Reference
background
PubMed Identifier
17034434
Citation
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.
Results Reference
background
PubMed Identifier
1552037
Citation
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.
Results Reference
background
PubMed Identifier
17555558
Citation
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.
Results Reference
background
PubMed Identifier
21311702
Citation
Sansone RA, Sansone LA. Getting a Knack for NAC: N-Acetyl-Cysteine. Innov Clin Neurosci. 2011 Jan;8(1):10-4.
Results Reference
background
PubMed Identifier
23632130
Citation
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.
Results Reference
background
PubMed Identifier
21606648
Citation
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.
Results Reference
background
PubMed Identifier
22549117
Citation
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.
Results Reference
background
PubMed Identifier
25771148
Citation
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.
Results Reference
background
PubMed Identifier
22319045
Citation
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.
Results Reference
background
PubMed Identifier
21792580
Citation
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.
Results Reference
background
PubMed Identifier
24520330
Citation
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.
Results Reference
background
PubMed Identifier
24676990
Citation
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.
Results Reference
background
PubMed Identifier
10890824
Citation
Spencer RL, Hutchison KE. Alcohol, aging, and the stress response. Alcohol Res Health. 1999;23(4):272-83.
Results Reference
background
PubMed Identifier
2597811
Citation
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.
Results Reference
background
PubMed Identifier
12671285
Citation
Urbanska EM, Czuczwar SJ, Kleinrok Z, Turski WA. Excitatory amino acids in epilepsy. Restor Neurol Neurosci. 1998;13(1-2):25-39.
Results Reference
background
PubMed Identifier
17136401
Citation
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.
Results Reference
background
PubMed Identifier
25734247
Citation
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.
Results Reference
background
PubMed Identifier
24067327
Citation
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.
Results Reference
background
PubMed Identifier
25087849
Citation
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.
Results Reference
background
PubMed Identifier
3203525
Citation
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. Erratum In: Controlled Clin Trials 1989 Mar;10(1):following 126.
Results Reference
background
PubMed Identifier
25494594
Citation
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.
Results Reference
background
PubMed Identifier
23528991
Citation
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.
Results Reference
background
PubMed Identifier
25338778
Citation
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.
Results Reference
background
PubMed Identifier
17719565
Citation
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.
Results Reference
background

Learn more about this trial

Effect of N-acetylcysteine on Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.

We'll reach out to this number within 24 hrs