Effectiveness of N-Acetylcysteine (NAC) in Motivational Enhancement Therapy for Nicotine Addiction

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Obtain the effectiveness of combination n-acetylcysteine and motivational enhancement therapy compared to a combination of motivational enhancement therapy and placebo on n-acetylaspartate levels in the brain 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 glutamate levels in the brain on nicotine addiction. Obtain an overview of nerve connectivity in nicotine addiction patient through post-therapy frontostriatal fMRI examination. Evaluate the side effects and severe side effects of NAC administration on nicotine addiction. Participants will: Get blood testing for nicotine in 1st, 6th and 12th weeks Fill the QSU-Brief, MTWS questionnaire every 2 weeks for 12 weeks Get motivational enhancement therapy every 2 weeks for 12 weeks Get fMRI in the 12th week Consume 3600 mg n-acetylcysteine for 12 consecutive weeks (for treatment group) and placebo (for control group) Researchers will compare the laboratory, clinical and radiology improvement in both groups

Official Title
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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

Conditions
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Nicotine Dependence, Nicotine Addiction

Intervention / Treatment
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* Drug: n-acetylcysteine
* Behavioral: Motivational Enhancement Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>3600 mg NAC per day in 12 weeks | Drug: n-acetylcysteine<br>* we give 3600 mg n-acetylcysteine divided twice a day, for 12 weeks<br>Behavioral: Motivational Enhancement Therapy<br>* Motivational enhancement therapy with individual and/or group session to maintain and increase subject's motivation to quit smoking<br>|
| Placebo Comparator: Placebo<br>Placebo | Behavioral: Motivational Enhancement Therapy<br>* Motivational enhancement therapy with individual and/or group session to maintain and increase subject's motivation to quit smoking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 2 | 
| Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 4 | 
| Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 6 | 
| Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 8 | 
| Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 10 | 
| Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 12 | 
| Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 2 | 
| Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 4 | 
| Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 6 | 
| Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 8 | 
| Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 10 | 
| Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 12 | 
| Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 2 | 
| Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 4 | 
| Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 6 | 
| Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 8 | 
| Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 10 | 
| Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 12 | 
| Level of blood nicotine | Level of blood nicotine | week 6 | 
| Level of blood nicotine | Level of blood nicotine | week 12 | 
| level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study | level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study | week 12 | 
| level of glutamate in Magnetic Resonance Spectroscopy (MRS) study | level of glutamate in Magnetic Resonance Spectroscopy (MRS) study | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effect of n-acetylcysteine consumption | Side Effect of n-acetylcysteine consumption | every 2 weeks for 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine Dependence; Nicotine Addiction; NAC