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

Primary Purpose

Nicotine Dependence, Nicotine Addiction

Status
Recruiting
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
n-acetylcysteine
Motivational Enhancement Therapy
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine Dependence; Nicotine Addiction; NAC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Faculty of Medicine, Universitas IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

3600 mg NAC per day in 12 weeks

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Side Effect of n-acetylcysteine consumption
Side Effect of n-acetylcysteine consumption

Full Information

First Posted
May 9, 2023
Last Updated
June 16, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05903014
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Nicotine Addiction
Keywords
Nicotine Dependence; Nicotine Addiction; NAC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
3600 mg NAC per day in 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
n-acetylcysteine
Intervention Description
we give 3600 mg n-acetylcysteine divided twice a day, for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy
Intervention Description
Motivational enhancement therapy with individual and/or group session to maintain and increase subject's motivation to quit smoking
Primary Outcome Measure Information:
Title
Rate of Abstinence
Description
number of patient that have been quick smoking at a specific period of time
Time Frame
week 2
Title
Rate of Abstinence
Description
number of patient that have been quick smoking at a specific period of time
Time Frame
week 4
Title
Rate of Abstinence
Description
number of patient that have been quick smoking at a specific period of time
Time Frame
week 6
Title
Rate of Abstinence
Description
number of patient that have been quick smoking at a specific period of time
Time Frame
week 8
Title
Rate of Abstinence
Description
number of patient that have been quick smoking at a specific period of time
Time Frame
week 10
Title
Rate of Abstinence
Description
number of patient that have been quick smoking at a specific period of time
Time Frame
week 12
Title
Score of Withdrawal Symptoms
Description
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
Time Frame
week 2
Title
Score of Withdrawal Symptoms
Description
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
Time Frame
week 4
Title
Score of Withdrawal Symptoms
Description
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
Time Frame
week 6
Title
Score of Withdrawal Symptoms
Description
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
Time Frame
week 8
Title
Score of Withdrawal Symptoms
Description
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
Time Frame
week 10
Title
Score of Withdrawal Symptoms
Description
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32
Time Frame
week 12
Title
Score of Craving Symptoms
Description
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
Time Frame
week 2
Title
Score of Craving Symptoms
Description
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
Time Frame
week 4
Title
Score of Craving Symptoms
Description
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
Time Frame
week 6
Title
Score of Craving Symptoms
Description
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
Time Frame
week 8
Title
Score of Craving Symptoms
Description
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
Time Frame
week 10
Title
Score of Craving Symptoms
Description
Score is assessed with Brief Questionnaire of Smoking Urges Questionnaire. Scale: 10-70
Time Frame
week 12
Title
Level of blood nicotine
Description
Level of blood nicotine
Time Frame
week 6
Title
Level of blood nicotine
Description
Level of blood nicotine
Time Frame
week 12
Title
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
Description
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
Time Frame
week 12
Title
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
Description
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Side Effect of n-acetylcysteine consumption
Description
Side Effect of n-acetylcysteine consumption
Time Frame
every 2 weeks for 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Faculty of Medicine, Universitas Indonesia
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tribowo TG Sugihen, MD
Phone
+628129294695
Email
t_tuahta@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19109354
Citation
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Results Reference
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Results Reference
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Citation
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Results Reference
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Citation
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Effectiveness of N-Acetylcysteine (NAC) in Motivational Enhancement Therapy for Nicotine Addiction

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