Clinical trial NCT02420418: The Effect of N- Acetylcysteine on Inflammatory and Oxidative Stress Biomarkers
Official title: The Effect of N- Acetylcysteine on Inflammatory and Oxidative Stress Biomarkers in Patients With Tobacco Use Disorders and Bipolar Disorders ..
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Keywords: Tobacco use disorder and bipolar disorders
N-acetylcysteine
Oxidative stress
inflammation
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: The effect of N- acetylcysteine on oxidative stress biomarkers in patients with tobacco use disorders and bipolar disorders
timeFrame: 12 weeks
measure: The effect of N- acetylcysteine on inflammatory in patients with tobacco use disorders and bipolar disorders
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: State University of Londrina
state: Paraná
Study officials:
affiliation: Universidade Estadual de Londrina
name: Kamila Landucci Bonifácio, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Estadual de Londrina
name: Ana Carolina Rossaneis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Machado RCBR, Vargas HO, Baracat MM, Urbano MR, Verri WA Jr, Porcu M, Nunes SOV. N-acetylcysteine as an adjunctive treatment for smoking cessation: a randomized clinical trial. Braz J Psychiatry. 2020 Sep-Oct;42(5):519-526. doi: 10.1590/1516-4446-2019-0753.