N-acetylcysteine for Tobacco Smoking

NCT02124525 | Unknown Phase 3 DMC

• 1 other identifier: UEL 33553/2011
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy of N-acetylcysteine (NAC) for smoking cessation in a double blind, randomized, placebo-controlled trial. Simultaneously, the study aims to elucidate the role of inflammatory markers and oxidative stress related to nicotine addiction and the use of NAC, an acetylated precursor of cysteine, a naturally occurring amino acid that has antioxidant actions in its own right, in reducing oxidative stress and inflammation in smokers. It will evaluate the use of NAC in smoking cessation, after 4, 8 and 12 weeks of treatment.

Conditions

Tobacco Smoking; Oxidative Stress; Inflammation

Outcome Measures

Primary Outcomes (1)

• The efficacy of N-acetylcysteine in reducing of the cigarettes per day

  The primary outcome will be the significant reduction of the cigarettes per day

  At Baseline and after 12 weeks (endpoint)

Secondary Outcomes (1)

• Efficacy of N-acetylcysteine in reducing exhaled Carbon Monoxide

  At Baseline and after 12 weeks (endpoint)

Study Arms (2)

N-acetylcysteine

PLACEBO COMPARATOR

Subjects receiving N-acetylcysteine (NAC): 6 pills/ day of N-acetylcysteine 500mg. Duration: 12 weeks

Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

Placebo will be taken for 12 weeks

Interventions

N-acetylcysteine DRUG

N-acetylcysteine 3000mg a day for 12 weeks versus Placebo for 12 weeks

Also known as: N-acetylcysteine 3000mg a day for 12 weeks

N-acetylcysteine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current daily smoker of 10 or more cigarettes per day
• Capacity to consent to the study and follow its instructions and procedures
• Female participants will need to be utilizing effective contraception if of childbearing age
• Must be able to swallow the pills

You may not qualify if:

• Clinically unstable medical or psychiatric disorders that require acute treatment
• Active gastrointestinal ulcers
• Pregnancy or breastfeeding
• Current use of vitamin supplements or other substances with recognized antioxidant action
• A history of anaphylactic reaction to NAC or any component of the preparation

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

Study Sites (1)

Hospital das Clínicas da Universidade Estadual de Londrina (Londrina State University Clinical Hospital)

Londrina, Paraná, 86055-900, Brazil

RECRUITING

MeSH Terms

Conditions

Tobacco Smoking; Inflammation

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sandra Nunes, MD, PhD

  Londrina State University - Center of Smoking Cessation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Prado, MD

CONTACT

55-43-9929-1702; eduardostp@hotmail.com

Sandra Nunes, MD

CONTACT

55-43-9801-9111; sandranunes@sercomtel.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 13, 2013
• First Posted: April 28, 2014
• Study Start: February 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

BR (1)