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

Phase 4

Completed

• Conditions: Nicotine Dependence; Nicotine Addiction
• Interventions: Drug: n-acetylcysteine; Behavioral: Motivational Enhancement Therapy

• Registration Number: NCT05903014
• Lead Sponsor: Indonesia University

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

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	n-acetylcysteine	3600 mg NAC per day in 12 weeks
Experimental	Motivational Enhancement Therapy	3600 mg NAC per day in 12 weeks
Placebo	Motivational Enhancement Therapy	Placebo

Primary Outcome Measures

Name	Time	Method
Rate of Abstinence	week 12	number of patient that have been quick smoking at a specific period of time
Score of Craving Symptoms	week 12	Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70
Score of Withdrawal Symptoms	week 12	Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Level of blood nicotine	week 12	Level of blood nicotine
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study	week 12	level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study	week 12	level of glutamate in Magnetic Resonance Spectroscopy (MRS) study

Secondary Outcome Measures

Name	Time	Method
Side Effect of n-acetylcysteine consumption	every 2 weeks for 12 weeks	Side Effect of n-acetylcysteine consumption

Trial Locations

Locations (1)

Faculty of Medicine, Universitas Indonesia; 🇮🇩 Jakarta, DKI Jakarta, Indonesia