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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
we give 3600 mg n-acetylcysteine divided twice a day, for 12 weeks
Motivational enhancement therapy with individual and/or group session to maintain and increase subject's motivation to quit smoking
Faculty of Medicine, Universitas Indonesia
Jakarta, DKI Jakarta, Indonesia
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Time frame: week 2
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Time frame: week 4
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Time frame: week 6
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Time frame: week 8
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Time frame: week 10
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Time frame: week 12
Score of Craving Symptoms
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Time frame: week 2
Score of Craving Symptoms
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Time frame: week 4
Score of Craving Symptoms
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
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Time frame: week 6
Score of Craving Symptoms
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Time frame: week 8
Score of Craving Symptoms
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Time frame: week 10
Score of Craving Symptoms
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Time frame: week 12
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32. Higher score means higger withdrawal symtomps
Time frame: week 2
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 4
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 6
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 8
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 10
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 12
Level of blood nicotine
Level of blood nicotine
Time frame: week 6
Level of blood nicotine
Level of blood nicotine
Time frame: week 12
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
Time frame: week 12
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
Time frame: week 12
Side Effect of n-acetylcysteine consumption
Side Effect of n-acetylcysteine consumption
Time frame: every 2 weeks for 12 weeks