NCT02737358

N-acetylcysteine for Tobacco Use Disorder

Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC) to assist in initial cessation and/or relapse prevention in adult cigarette smokers.

Detailed description

The aim of this study is to assess the effects of N-acetylcysteine (NAC) on initial cessation and relapse prevention in adult cigarette smokers. Specifically, this study has the following aims: Aim 1) Examine the efficacy of NAC, compared to placebo, in helping smokers achieve three days of continuous abstinence; Aim 2) Among those who maintain initial 3-day abstinence, examine the time to relapse over the 8-week intervention between NAC and placebo groups; Aim 3) Assess 7-day point prevalence abstinence at the 8-week end-of-treatment study visit in order to obtain effect sizes and estimates of variability to power a randomized clinical trial.

Conditions

• Nicotine Dependence
• Smoking

Interventions

Type	Name	Description
DRUG	N-acetylcysteine (NAC)	NAC or matched placebo will be given to study participants for 8 weeks.
OTHER	Placebo	Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support.

Timeline

• Start date: 2016-08-30
• Primary completion: 2019-08-01
• Completion: 2019-10-10
• First posted: 2016-04-13
• Last updated: 2020-08-17
• Results posted: 2020-08-17

Locations

1 site across 1 country: United States