NCT02420418

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

10 months

First QC Date

January 22, 2015

Last Update Submit

June 22, 2015

Conditions

Bipolar Disorder

Keywords

Tobacco use disorder and bipolar disordersN-acetylcysteineOxidative stressinflammation

Outcome Measures

Primary Outcomes (2)

  • The effect of N- acetylcysteine on oxidative stress biomarkers in patients with tobacco use disorders and bipolar disorders

    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).

    12 weeks

  • The effect of N- acetylcysteine on inflammatory in patients with tobacco use disorders and bipolar disorders

    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.

    12 weeks

Study Arms (2)

NAC ( baseline )and 12 week

ACTIVE COMPARATOR

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)

placebo ( baseline ) and 12 week

PLACEBO COMPARATOR

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

Interventions

N-acetyl-cysteine (NAC)DIETARY_SUPPLEMENT

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.

NAC ( baseline )and 12 week
PlaceboOTHER

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

placebo ( baseline ) and 12 week

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Londrina

Londrina, Paraná, 86.057-970, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 32725102DERIVED

MeSH Terms

Conditions

Bipolar DisorderTobacco Use DisorderInflammation

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSubstance-Related DisordersChemically-Induced DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Kamila Landucci Bonifácio, MS

    Universidade Estadual de Londrina

    PRINCIPAL INVESTIGATOR

  • Ana Carolina Rossaneis, PhD

    Universidade Estadual de Londrina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Décio Sabbatini Barbosa, PhD

CONTACT

+554399966381sabbatini2011@hotmail.com

Waldiceu Aparecido Verri Jr, PhD

CONTACT

+554333714979waldicel.verri@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

January 22, 2015

First Posted

April 17, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

BR(1)