Clinical trial NCT05903014: Effectiveness of N-Acetylcysteine (NAC) in Motivational Enhancement Therapy for Nicotine Addiction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nicotine Dependence
Nicotine Addiction
Keywords: Nicotine Dependence; Nicotine Addiction; NAC
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of Abstinence
timeFrame: week 2
measure: Rate of Abstinence
timeFrame: week 4
measure: Rate of Abstinence
timeFrame: week 6
measure: Rate of Abstinence
timeFrame: week 8
measure: Rate of Abstinence
timeFrame: week 10
measure: Rate of Abstinence
timeFrame: week 12
measure: Score of Craving Symptoms
timeFrame: week 2
measure: Score of Craving Symptoms
timeFrame: week 4
measure: Score of Craving Symptoms
timeFrame: week 6
measure: Score of Craving Symptoms
timeFrame: week 8
measure: Score of Craving Symptoms
timeFrame: week 10
measure: Score of Craving Symptoms
timeFrame: week 12
measure: Score of Withdrawal Symptoms
timeFrame: week 2
measure: Score of Withdrawal Symptoms
timeFrame: week 4
measure: Score of Withdrawal Symptoms
timeFrame: week 6
measure: Score of Withdrawal Symptoms
timeFrame: week 8
measure: Score of Withdrawal Symptoms
timeFrame: week 10
measure: Score of Withdrawal Symptoms
timeFrame: week 12
measure: Level of blood nicotine
timeFrame: week 6
measure: Level of blood nicotine
timeFrame: week 12
measure: level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
timeFrame: week 12
measure: level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
timeFrame: week 12
Secondary outcomes:
measure: Side Effect of n-acetylcysteine consumption
timeFrame: every 2 weeks for 12 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
state: DKI Jakarta
Study officials:
References:
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