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

June 16, 2023 updated by: dr. Tribowo Tuahta Ginting Sugihen, SpKJ(K), Indonesia University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Faculty of Medicine, Universitas Indonesia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Behavioral: Motivational Enhancement Therapy
Motivational enhancement therapy with individual and/or group session to maintain and increase subject's motivation to quit smoking
Experimental: Experimental
3600 mg NAC per day in 12 weeks
Drug: n-acetylcysteine
we give 3600 mg n-acetylcysteine divided twice a day, for 12 weeks
Behavioral: Motivational Enhancement Therapy
Motivational enhancement therapy with individual and/or group session to maintain and increase subject's motivation to quit smoking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Abstinence
Time Frame: week 2
number of patient that have been quick smoking at a specific period of time
week 2
Rate of Abstinence
Time Frame: week 4
number of patient that have been quick smoking at a specific period of time
week 4
Rate of Abstinence
Time Frame: week 6
number of patient that have been quick smoking at a specific period of time
week 6
Rate of Abstinence
Time Frame: week 8
number of patient that have been quick smoking at a specific period of time
week 8
Rate of Abstinence
Time Frame: week 10
number of patient that have been quick smoking at a specific period of time
week 10
Rate of Abstinence
Time Frame: week 12
number of patient that have been quick smoking at a specific period of time
week 12
Score of Withdrawal Symptoms
Time Frame: week 2
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
week 2
Score of Withdrawal Symptoms
Time Frame: week 4
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
week 4
Score of Withdrawal Symptoms
Time Frame: week 6
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
week 6
Score of Withdrawal Symptoms
Time Frame: week 8
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
week 8
Score of Withdrawal Symptoms
Time Frame: week 10
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
week 10
Score of Withdrawal Symptoms
Time Frame: week 12
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
week 12
Score of Craving Symptoms
Time Frame: week 2
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
week 2
Score of Craving Symptoms
Time Frame: week 4
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
week 4
Score of Craving Symptoms
Time Frame: week 6
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
week 6
Score of Craving Symptoms
Time Frame: week 8
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
week 8
Score of Craving Symptoms
Time Frame: week 10
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
week 10
Score of Craving Symptoms
Time Frame: week 12
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
week 12
Level of blood nicotine
Time Frame: week 6
Level of blood nicotine
week 6
Level of blood nicotine
Time Frame: week 12
Level of blood nicotine
week 12
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
Time Frame: week 12
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
week 12
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
Time Frame: week 12
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side Effect of n-acetylcysteine consumption
Time Frame: every 2 weeks for 12 weeks
Side Effect of n-acetylcysteine consumption
every 2 weeks for 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-06-0672

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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