Faculty of Medicine, Universitas Indonesia
Jakarta, DKI Jakarta, 10430, Indonesia
NCT Number: NCT05903014
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Jakarta, DKI Jakarta, 10430, Indonesia
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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)
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
Time frame: week 2
number of patient that have been quick smoking at a specific period of time
Time frame: week 4
number of patient that have been quick smoking at a specific period of time
Time frame: week 6
number of patient that have been quick smoking at a specific period of time
Time frame: week 8
number of patient that have been quick smoking at a specific period of time
Time frame: week 10
number of patient that have been quick smoking at a specific period of time
Time frame: week 12
number of patient that have been quick smoking at a specific period of time
Time frame: week 2
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 is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Time frame: week 6
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 is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Time frame: week 10
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 is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Time frame: week 2
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32. Higher score means higger withdrawal symtomps
Time frame: week 4
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 6
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 8
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 10
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 12
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Time frame: week 6
Level of blood nicotine
Time frame: week 12
Level of blood nicotine
Time frame: week 12
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
Time frame: week 12
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
Time frame: every 2 weeks for 12 weeks
Side Effect of n-acetylcysteine consumption
Indonesia University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05430334
Behavior, Chemically-Induced Disorders
Beirut, Lebanon
View Trial DetailsNCT05897242
Behavior, Chemically-Induced Disorders
Seattle, Washington, United States
View Trial DetailsNCT06910566
Behavior, Chemically-Induced Disorders
Lille, France
View Trial DetailsNCT07737288
Behavior, Chemically-Induced Disorders
Izmir, Turkey (Türkiye)
View Trial Details