Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Daily smoker for ≥6 months, smoking approximately ≥5 cigarettes per day on average in the past month or must meet the criteria for nicotine dependence
- •Be interested in quitting smoking (defined as a 2 or above on a 10-point Likert scale assessing readiness and interest in quitting (1=not at all ready/interested, 10=extremely ready/interested)
- •Willing to engage in a 3-day quit attempt as part of study procedures
- •Willing to abstain from cannabis use during study procedures (since inhaled cannabis will affect breath carbon monoxide readings).
- •If female, agreement to use birth control (any form) to avoid pregnancy during study procedures
排除标准
- •Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than tobacco use disorder) in the past month that may interfere with study performance based on PI judgment
- •Current pregnancy or breastfeeding
- •Current use of medications with smoking cessation efficacy
- •Known hypersensitivity to NAC
- •Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
研究组 & 干预措施
Placebo
Matched placebo will be given to half of the study participants.
干预措施: Placebo (Other)
N-Acetylcysteine (NAC)
NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)
干预措施: N-acetylcysteine (NAC) (Drug)
结局指标
主要结局
Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol.
时间窗: Days 1-3 of the study protocol
Abstinence will be measured through biochemical verification via breath carbon monoxide. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels.
次要结局
- Days to Relapse to Smoking Among Abstinent Participants(Days 4-56 of the study protocol)
- Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit(Days 49-56)
研究者
Erin McClure
Assistant Professor
Medical University of South Carolina