Nicotine Dependence Clinical Trial
Official title:
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
Verified date | June 2023 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 88 |
Est. completion date | December 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Male or female who are active smokers are at least 18 years old and decide to stop smoking 2. Using tobacco cigarettes whether filtered or not 3. Active smoker for at least 6 months 4. Smoke at least 10 cigarettes per day 5. Currently in the preparation or action stage at the stage of changes 6. 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) |
Country | Name | City | State |
---|---|---|---|
Indonesia | Faculty of Medicine, Universitas Indonesia | Jakarta | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
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McClure EA, Baker NL, Gipson CD, Carpenter MJ, Roper AP, Froeliger BE, Kalivas PW, Gray KM. An open-label pilot trial of N-acetylcysteine and varenicline in adult cigarette smokers. Am J Drug Alcohol Abuse. 2015 Jan;41(1):52-6. doi: 10.3109/00952990.2014.933839. Epub 2014 Jul 25. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 2 | |
Primary | Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 4 | |
Primary | Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 6 | |
Primary | Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 8 | |
Primary | Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 10 | |
Primary | Rate of Abstinence | number of patient that have been quick smoking at a specific period of time | week 12 | |
Primary | Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 2 | |
Primary | Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 4 | |
Primary | Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 6 | |
Primary | Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 8 | |
Primary | Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 10 | |
Primary | Score of Withdrawal Symptoms | Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32 | week 12 | |
Primary | Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 2 | |
Primary | Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 4 | |
Primary | Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 6 | |
Primary | Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 8 | |
Primary | Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 10 | |
Primary | Score of Craving Symptoms | Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70 | week 12 | |
Primary | Level of blood nicotine | Level of blood nicotine | week 6 | |
Primary | Level of blood nicotine | Level of blood nicotine | week 12 | |
Primary | level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study | level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study | week 12 | |
Primary | level of glutamate in Magnetic Resonance Spectroscopy (MRS) study | level of glutamate in Magnetic Resonance Spectroscopy (MRS) study | week 12 | |
Secondary | Side Effect of n-acetylcysteine consumption | Side Effect of n-acetylcysteine consumption | every 2 weeks for 12 weeks |
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