Effectiveness of N-Acetylcysteine in Motivational Enhancement Therapy for Nicotine Addiction: Study on the Dopaminergic Pathways, Changes in Functional Connectivity of fMRI Bold, and Changes in Smoking Abstinence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Rate of Abstinence
研究概览
简要总结
The goal of this clinical trial is to determine the effectiveness of the combination of n-acetylcysteine and motivational enhancement therapy on laboratory improvement in the form of changes in blood nicotine, radiological changes in the form of nerve connectivity on post-therapy frontostriatal fMRI examination and clinical changes in the form of abstinence, withdrawal symptoms and cravings in adult smoker.
详细描述
The main question it aims to answer are:
Obtain the effectiveness of combination of n-acetylcysteine and motivational enhancement therapy compared to a combination of motivational enhancement therapy and placebo on nicotine withdrawal symptom scores on nicotine addiction.
Obtaining the effectiveness of the combination of n-acetylcysteine and motivational enhancement therapy compared to the combination of motivational enhancement therapy and placebo on craving symptom scores on nicotine addiction.
Obtain the effectiveness of giving a combination of n-acetylcysteine and motivational enhancement therapy compared to a combination of motivational enhancement therapy and placebo in the incidence of abstinence in nicotine addiction.
Obtain the effectiveness of combination n-acetylcysteine and motivational enhancement therapy compared to a combination of motivational enhancement therapy and placebo on blood nicotine levels in nicotine addiction.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male or female who are active smokers are at least 18 years old and decide to stop smoking
- •Using tobacco cigarettes whether filtered or not
- •Active smoker for at least 6 months
- •Smoke at least 10 cigarettes per day
- •Currently in the preparation or action stage at the stage of changes
- •Able to follow instructions and research procedures
排除标准
- •Have/ suspected to have a systemic medical disorder or psychiatric disorder requiring acute management Currently using electronic cigarettes Currently using oral glucocorticoids Have an acute gastrointestinal ulcer Pregnant or breastfeeding or planning to become pregnant within the next 6 months Currently consume n-acetylcysteine Have a history of allergic reactions with n-acetylcysteine or its components Get therapy to stop smoking such as bupropion, varenicline or nicotine replacement therapy (NRT)
研究组 & 干预措施
Experimental
3600 mg NAC per day in 12 weeks
干预措施: n-acetylcysteine (Drug)
Experimental
3600 mg NAC per day in 12 weeks
干预措施: Motivational Enhancement Therapy (Behavioral)
Placebo
Placebo
干预措施: Motivational Enhancement Therapy (Behavioral)
结局指标
主要结局
Rate of Abstinence
时间窗: week 12
number of patient that have been quick smoking at a specific period of time
Score of Craving Symptoms
时间窗: week 12
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Score of Withdrawal Symptoms
时间窗: week 12
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Level of blood nicotine
时间窗: week 12
Level of blood nicotine
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
时间窗: week 12
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
时间窗: week 12
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
次要结局
- Side Effect of n-acetylcysteine consumption(every 2 weeks for 12 weeks)
研究者
dr. Tribowo Tuahta Ginting Sugihen, SpKJ(K)
Head of Psychiatry Departement Persahabatan National Hospital
Indonesia University