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The Effect of N- Acetylcysteine on Inflammatory and Oxidative Stress Biomarkers (nac)

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ClinicalTrials.gov Identifier: NCT02420418
Recruitment Status : Unknown
Verified June 2015 by Sandra Odebrecht Vargas Nunes, Universidade Estadual de Londrina.
Recruitment status was:  Not yet recruiting
First Posted : April 17, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Sandra Odebrecht Vargas Nunes, Universidade Estadual de Londrina

Brief Summary:

Background: . Bipolar disorders and tobacco use disorder are top of the causes of disability and mortality worldwide Objective: The aim of this study was to evaluate N-acetyl-cysteine (NAC) as an adjunctive treatment in patients with bipolar .disorders and tobacco use disorder (TUD)

, to determine whether NAC reduces alterations in biomarkers of inflammatory and oxidative stress Methods: This study will be conducted as a double-blind, randomized, placebo controlles add NAC or placebo for .bipolar disorders and tobacco use disorder at Londrina State University, Brazil.


Condition or disease Intervention/treatment Phase
Bipolar Disorder Dietary Supplement: N-acetyl-cysteine (NAC) Other: Placebo Not Applicable

Detailed Description:

Tobacco use disorder and bipolar disorders are top of the causes of disability and mortality worldwide. The aim of this study was to evaluate N-acetyl-cysteine (NAC) as an adjunctive treatment in patients with Tobacco use disorder with comorbid bipolar disorder ( (N=72 NAC/placebo ) recruited from outpatients smoking cessation unit at Londrina State University, Brazil.

The design was a randomized, double-blind, placebo controlled clinical trial of 12 weeks of adjunctive treatment with N-acetyl-cysteine (NAC), 1800mg/day. Participants will be patients with bipolar disorders with and without TUD, they will allocated to one of two groups at random to receive NAC or placebo For the evaluation of oxidative stress biomarkers will be assess among others malondialdehyde (MDA), lipid hydroperoxide,nitric oxide metabolites (NOx), antioxidant potential total plasma (TRAP), advanced oxidation protein products (AOPP), superoxide dismutase (SOD), catalase, the total glutathione (GSH) and oxidized (GSSG), paraoxonase (PON 1) activity thiol group (SH-group).For the evaluation of inflammation biomarkers will be analyze : BDNF, GM-CSF, IFN-γ, IL-1β, IL-10, IL-12 (p70), IL-13, IL-15, IL-17, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6,IL-6R, IL-7, IL-8, Leptin, TNF-α, TNF-RI, TNF-RII, high-sensitivity C-reactive protein (hs-CRP), erythrocytes sedimentation rate (ESR), homocysteine, haptoglobin, albumin , uric acid and fibrinogen.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of N- Acetylcysteine on Inflammatory and Oxidative Stress Biomarkers in Patients With Tobacco Use Disorders and Bipolar Disorders ..
Study Start Date : July 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Active Comparator: NAC ( baseline )and 12 week

subjects with tobacco use disorder (TUD) and bipolar disorders who will receive N-acetyl-cysteine (NAC) or placebo at baseline for a period of 12 weeks The participants with TUD (n=72) and they will receive a 1800mg per day of NAC or matching placebo .

There will be asses laboratory examinations for inflammatory and oxidative stress biomarkers at baseline and at 12 week

Dietary Supplement: N-acetyl-cysteine (NAC)
Patients will be randomly allocated into two groups, double-blind, to receive NAC or placebo for a period of 12 weeks. All groups remain receiving maintenance treatment in outpatient smokiing cessation. The dosage will be fixed 1800 mg/day of NAC administered in capsules taken 2 before breakfast and 2 before dinner is equal doses.

Placebo Comparator: placebo ( baseline ) and 12 week

subjects with tobacco use disorders (TUD and bipolar disorders who will receive N-acetyl-cysteine (NAC) or placebo for a period of 12 weeks.

The participants with TUD and bipolar disorders (n=72) and they will receive a 1800mg per day of NAC or matching placebo .

There will be assessed laboratory examinations for inflammatory and oxidative stress biomarkers at baseline and at 12 week

Other: Placebo
Patients will be randomly allocated into two groups, double-blind, to receive NAC or placebo for a period of 12 weeks. All groups remain receiving maintenance treatment in smoking cessation service




Primary Outcome Measures :
  1. The effect of N- acetylcysteine on oxidative stress biomarkers in patients with tobacco use disorders and bipolar disorders [ Time Frame: 12 weeks ]
    The design was a randomized, double-blind, placebo controlled clinical trial of 12 weeks of adjunctive treatment with N-acetyl-cysteine (NAC). For the evaluation of oxidative stress biomarkers will be assess among others malondialdehyde (MDA), lipid hydroperoxide,nitric oxide metabolites (NOx), antioxidant potential total plasma (TRAP), advanced oxidation protein products (AOPP), superoxide dismutase (SOD), catalase, the total glutathione (GSH) and oxidized (GSSG), paraoxonase (PON 1) activity thiol group (SH-group).

  2. The effect of N- acetylcysteine on inflammatory in patients with tobacco use disorders and bipolar disorders [ Time Frame: 12 weeks ]
    For the evaluation of inflammation biomarkers will be analyze : BDNF, GM-CSF, IFN-γ, IL-1β, IL-10, IL-12 (p70), IL-13, IL-15, IL-17, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6,IL-6R, IL-7, IL-8, Leptin, TNF-α, TNF-RI, TNF-RII, high-sensitivity C-reactive protein (hs-CRP), erythrocytes sedimentation rate (ESR), homocysteine, haptoglobin, albumin , uric acid and fibrinogen.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To be included in this study participants must be motivated smokers to stop tobacco use
  • Age greater than or equal to 18 and less than 65 years
  • Both sexes
  • All races
  • Capacity to consent to the study and carefully follow the guidelines and procedures and sign the term of free and informed consent .
  • Will be included with comorbid bipolar, depressive and anxiety disorder with tobacco use by more than 20 cigarettes per day, and a control group without these mood disorders and without tobacco use disorder.

Exclusion Criteria:

  • We excluded any subjects with: abnormal blood values on the following laboratory tests: *hemogram, aspartate transaminase (AST), alanine transaminase (ALT), urea and creatinine

    • other actual and life-time axis-I diagnoses (including schizophrenia, psycho-organic syndromes, delirium, dementia, amnestic, and other cognitive disorders)
    • medical illness, including HIV and hepatitis B and C, (auto)immune disorders
    • immune modulatory drugs, e.g. glucocorticoids and use of antioxidants.
  • These situations can affect an inflammatory and / or immune process.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420418


Contacts
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Contact: Décio Sabbatini Barbosa, PhD +554399966381 sabbatini2011@hotmail.com
Contact: Waldiceu Aparecido Verri Jr, PhD +554333714979 waldicel.verri@gmail.com

Locations
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Brazil
State University of Londrina Not yet recruiting
Londrina, Paraná, Brazil, 86.057-970
Contact: Kamila Landucci Bonifácio, MS    +554333386447    kamilalondrina@hotmail.com   
Principal Investigator: Kamila Landucci Bonifácio, MS         
Principal Investigator: Ana Carolina Rossaneis, PhD         
Sponsors and Collaborators
Universidade Estadual de Londrina
Investigators
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Principal Investigator: Kamila Landucci Bonifácio, MS Universidade Estadual de Londrina
Principal Investigator: Ana Carolina Rossaneis, PhD Universidade Estadual de Londrina

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Responsible Party: Sandra Odebrecht Vargas Nunes, PHD, Universidade Estadual de Londrina
ClinicalTrials.gov Identifier: NCT02420418     History of Changes
Other Study ID Numbers: ULondrina
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Sandra Odebrecht Vargas Nunes, Universidade Estadual de Londrina:
Tobacco use disorder and bipolar disorders
N-acetylcysteine
Oxidative stress
inflammation

Additional relevant MeSH terms:
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Bipolar Disorder
Tobacco Use Disorder
Bipolar and Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes