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

NCT05903014 | Completed Phase 4

• 1 other identifier: 22-06-0672
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Nicotine Addiction

Keywords

Nicotine Dependence; Nicotine Addiction; NAC

Outcome Measures

Primary Outcomes (22)

• Rate of Abstinence

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

  week 2

• Rate of Abstinence

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

  week 4

• Rate of Abstinence

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

  week 6

• Rate of Abstinence

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

  week 8

• Rate of Abstinence

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

  week 10

• Rate of Abstinence

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

  week 12

• Score of Craving Symptoms

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

  week 2

• Score of Craving Symptoms

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

  week 4

• Score of Craving Symptoms

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

  week 6

• Score of Craving Symptoms

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

  week 8

• Score of Craving Symptoms

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

  week 10

• Score of Craving Symptoms

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

  week 12

• Score of Withdrawal Symptoms

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

  week 2

• Score of Withdrawal Symptoms

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

  week 4

• Score of Withdrawal Symptoms

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

  week 6

• Score of Withdrawal Symptoms

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

  week 8

• Score of Withdrawal Symptoms

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

  week 10

• Score of Withdrawal Symptoms

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

  week 12

• Level of blood nicotine

  Level of blood nicotine

  week 6

• Level of blood nicotine

  Level of blood nicotine

  week 12

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

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

  week 12

• level of glutamate in Magnetic Resonance Spectroscopy (MRS) study

  level of glutamate in Magnetic Resonance Spectroscopy (MRS) study

  week 12

Secondary Outcomes (1)

• Side Effect of n-acetylcysteine consumption

  every 2 weeks for 12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

3600 mg NAC per day in 12 weeks

Drug: n-acetylcysteine; Behavioral: Motivational Enhancement Therapy

Placebo

PLACEBO COMPARATOR

Placebo

Behavioral: Motivational Enhancement Therapy

Interventions

n-acetylcysteine DRUG

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

Experimental

Motivational Enhancement Therapy BEHAVIORAL

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

Experimental; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (9)

• Mottillo S, Filion KB, Belisle P, Joseph L, Gervais A, O'Loughlin J, Paradis G, Pihl R, Pilote L, Rinfret S, Tremblay M, Eisenberg MJ. Behavioural interventions for smoking cessation: a meta-analysis of randomized controlled trials. Eur Heart J. 2009 Mar;30(6):718-30. doi: 10.1093/eurheartj/ehn552. Epub 2008 Dec 24.

  PMID: 19109354 BACKGROUND

• Schmaal L, Berk L, Hulstijn KP, Cousijn J, Wiers RW, van den Brink W. Efficacy of N-acetylcysteine in the treatment of nicotine dependence: a double-blind placebo-controlled pilot study. Eur Addict Res. 2011;17(4):211-6. doi: 10.1159/000327682. Epub 2011 May 24.

  PMID: 21606648 BACKGROUND

• Prado E, Maes M, Piccoli LG, Baracat M, Barbosa DS, Franco O, Dodd S, Berk M, Vargas Nunes SO. N-acetylcysteine for therapy-resistant tobacco use disorder: a pilot study. Redox Rep. 2015 Sep;20(5):215-22. doi: 10.1179/1351000215Y.0000000004. Epub 2015 Mar 2.

  PMID: 25729878 BACKGROUND

• Schulte M, Goudriaan AE, Kaag AM, Kooi DP, van den Brink W, Wiers RW, Schmaal L. The effect of N-acetylcysteine on brain glutamate and gamma-aminobutyric acid concentrations and on smoking cessation: A randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2017 Oct;31(10):1377-1379. doi: 10.1177/0269881117730660. Epub 2017 Sep 19.

  PMID: 28922968 BACKGROUND

• Machado RCBR, Vargas HO, Baracat MM, Urbano MR, Verri WA Jr, Porcu M, Nunes SOV. N-acetylcysteine as an adjunctive treatment for smoking cessation: a randomized clinical trial. Braz J Psychiatry. 2020 Sep-Oct;42(5):519-526. doi: 10.1590/1516-4446-2019-0753.

  PMID: 32725102 BACKGROUND

• Froeliger B, McConnell PA, Stankeviciute N, McClure EA, Kalivas PW, Gray KM. The effects of N-Acetylcysteine on frontostriatal resting-state functional connectivity, withdrawal symptoms and smoking abstinence: A double-blind, placebo-controlled fMRI pilot study. Drug Alcohol Depend. 2015 Nov 1;156:234-242. doi: 10.1016/j.drugalcdep.2015.09.021. Epub 2015 Sep 26.

  PMID: 26454838 BACKGROUND

• McClure EA, Baker NL, Gipson CD, Carpenter MJ, Roper AP, Froeliger BE, Kalivas PW, Gray KM. An open-label pilot trial of N-acetylcysteine and varenicline in adult cigarette smokers. Am J Drug Alcohol Abuse. 2015 Jan;41(1):52-6. doi: 10.3109/00952990.2014.933839. Epub 2014 Jul 25.

  PMID: 25062287 BACKGROUND

• Bernardo M, Dodd S, Gama CS, Copolov DL, Dean O, Kohlmann K, Jeavons S, Schapkaitz I, Anderson-Hunt M, Bush AI, Berk M. Effects of N-acetylcysteine on substance use in bipolar disorder: A randomised placebo-controlled clinical trial. Acta Neuropsychiatr. 2009 Dec;21(6):285-91. doi: 10.1111/j.1601-5215.2009.00397.x.

  PMID: 25384734 BACKGROUND

• Knackstedt LA, LaRowe S, Mardikian P, Malcolm R, Upadhyaya H, Hedden S, Markou A, Kalivas PW. The role of cystine-glutamate exchange in nicotine dependence in rats and humans. Biol Psychiatry. 2009 May 15;65(10):841-5. doi: 10.1016/j.biopsych.2008.10.040. Epub 2008 Dec 21.

  PMID: 19103434 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Acetylcysteine; Motivational Interviewing

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychiatry Departement Persahabatan National Hospital

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 15, 2023
• Study Start: January 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)