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Completed

NCT Number: NCT05903014

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Universitas Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female who are active smokers are at least 18 years old and decide to stop smoking
  • Using tobacco cigarettes whether filtered or not
  • Active smoker for at least 6 months
  • Smoke at least 10 cigarettes per day
  • Currently in the preparation or action stage at the stage of changes
  • 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)

Treatment and study plan

N-acetylcysteine

Drug

we give 3600 mg n-acetylcysteine divided twice a day, for 12 weeks

Motivational Enhancement Therapy

Behavioral

Motivational enhancement therapy with individual and/or group session to maintain and increase subject's motivation to quit smoking

Primary outcomes

  1. Rate of Abstinence

    Time frame: week 2

    number of patient that have been quick smoking at a specific period of time

  2. Rate of Abstinence

    Time frame: week 4

    number of patient that have been quick smoking at a specific period of time

  3. Rate of Abstinence

    Time frame: week 6

    number of patient that have been quick smoking at a specific period of time

  4. Rate of Abstinence

    Time frame: week 8

    number of patient that have been quick smoking at a specific period of time

  5. Rate of Abstinence

    Time frame: week 10

    number of patient that have been quick smoking at a specific period of time

  6. Rate of Abstinence

    Time frame: week 12

    number of patient that have been quick smoking at a specific period of time

  7. Score of Craving Symptoms

    Time frame: week 2

    Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70

  8. Score of Craving Symptoms

    Time frame: week 4

    Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70

  9. Score of Craving Symptoms

    Time frame: week 6

    Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70

  10. Score of Craving Symptoms

    Time frame: week 8

    Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70

  11. Score of Craving Symptoms

    Time frame: week 10

    Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70

  12. Score of Craving Symptoms

    Time frame: week 12

    Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Higher score means higher urgency to smoke. Scale: 10-70

  13. Score of Withdrawal Symptoms

    Time frame: week 2

    Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32. Higher score means higger withdrawal symtomps

  14. Score of Withdrawal Symptoms

    Time frame: week 4

    Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32

  15. Score of Withdrawal Symptoms

    Time frame: week 6

    Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32

  16. Score of Withdrawal Symptoms

    Time frame: week 8

    Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32

  17. Score of Withdrawal Symptoms

    Time frame: week 10

    Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32

  18. Score of Withdrawal Symptoms

    Time frame: week 12

    Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32

  19. Level of blood nicotine

    Time frame: week 6

    Level of blood nicotine

  20. Level of blood nicotine

    Time frame: week 12

    Level of blood nicotine

  21. level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study

    Time frame: week 12

    level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study

  22. level of glutamate in Magnetic Resonance Spectroscopy (MRS) study

    Time frame: week 12

    level of glutamate in Magnetic Resonance Spectroscopy (MRS) study

Secondary outcomes

  1. Side Effect of n-acetylcysteine consumption

    Time frame: every 2 weeks for 12 weeks

    Side Effect of n-acetylcysteine consumption

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Oct 8, 2024

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.

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