Overview

N-acetylcysteine for Tobacco Smoking

Status:
Unknown status
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universidade Estadual de Londrina
Treatments:
Acetylcysteine
N-monoacetylcystine
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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