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

Sponsor

Universidade Estadual de Londrina (Other)

Overall Status

Unknown status

CT.gov ID

NCT02420418

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2015

Anticipated Primary Completion Date :

May 1, 2016

Anticipated Study Completion Date :

May 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The effect of N- acetylcysteine on oxidative stress biomarkers in patients with tobacco use disorders and bipolar disorders [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).
The effect of N- acetylcysteine on inflammatory in patients with tobacco use disorders and bipolar disorders [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State University of Londrina	Londrina	Paraná	Brazil	86.057-970

Sponsors and Collaborators

Universidade Estadual de Londrina

Investigators

Principal Investigator: Kamila Landucci Bonifácio, MS, Universidade Estadual de Londrina
Principal Investigator: Ana Carolina Rossaneis, PhD, Universidade Estadual de Londrina