Nicotine DependencePhase 4NCT05903014
Effectiveness of N-Acetylcysteine (NAC) in Motivational Enhancement Therapy for Nicotine Addiction
A Phase 4 study testing n-acetylcysteine and Motivational Enhancement Therapy in people with Nicotine Dependence and Nicotine Addiction, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Nicotine Addiction
- What is being tested?
- n-acetylcysteine and Motivational Enhancement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 30 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Indonesia
Jakarta, DKI Jakarta, 10430
About this study
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
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.
Read the 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
- Conditions
- Nicotine Dependence, Nicotine Addiction
- Being tested
- n-acetylcysteine, Motivational Enhancement Therapy
- Keywords
- Nicotine Dependence; Nicotine Addiction; NAC
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-acetylcysteineDrug
we give 3600 mg n-acetylcysteine divided twice a day, for 12 weeks
Motivational Enhancement TherapyBehavioural
Motivational enhancement therapy with individual and/or group session to maintain and increase subject's motivation to quit smoking
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 3600 mg NAC per day in 12 weeks Receives: Drug: n-acetylcysteine; Behavioral: Motivational Enhancement Therapy |
| Placebo | Placebo comparator | Placebo Receives: Behavioral: Motivational Enhancement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Measured: week 2
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Measured: week 4
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Measured: week 6
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Measured: week 8
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Measured: week 10
Rate of Abstinence
number of patient that have been quick smoking at a specific period of time
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: week 12
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Scale: 0-32. Higher score means higger withdrawal symtomps
Measured: week 2
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Measured: week 4
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Measured: week 6
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Measured: week 8
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Measured: week 10
Score of Withdrawal Symptoms
Score is assessed with Minnesota Tobacco Withdrawal Scale Questionnaire. Higher score means higger withdrawal symtomps Scale: 0-32
Measured: week 12
Level of blood nicotine
Level of blood nicotine
Measured: week 6
Level of blood nicotine
Level of blood nicotine
Measured: week 12
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
Measured: week 12
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
Measured: week 12
Secondary outcomes (1)
Side Effect of n-acetylcysteine consumption
Side Effect of n-acetylcysteine consumption
Measured: every 2 weeks for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jan 2023
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Tribowo Tuahta Ginting Sugihen, SpKJ(K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903014
- Sponsor's protocol ID
- 22-06-0672
- Status last verified
- Oct 2024
- First submitted
- 9 May 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19109354Schmaal 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.
PubMed 21606648Prado 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.
PubMed 25729878Schulte 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.
PubMed 28922968Machado 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.
PubMed 32725102Froeliger 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.
PubMed 26454838McClure 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.
PubMed 25062287Bernardo 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.
PubMed 25384734Knackstedt 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.
PubMed 19103434
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05903014
- Acronym / sponsor ID
- 22-06-0672
- Conditions
- Nicotine Dependence, Nicotine Addiction
- Keywords
- Nicotine Dependence; Nicotine Addiction; NAC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: n-acetylcysteine, Behavioral: Motivational Enhancement Therapy3600 mg NAC per day in 12 weeks |
| Placebo | Placebo comparator | Behavioral: Motivational Enhancement TherapyPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-acetylcysteinewe give 3600 mg n-acetylcysteine divided twice a day, for 12 weeks | Drug | Experimental |
| Motivational Enhancement TherapyMotivational enhancement therapy with individual and/or group session to maintain and increase subject's motivation to quit smoking | Behavioural | Experimental, Placebo |
Primary outcome
Rate of Abstinence
Time frame: week 2
number of patient that have been quick smoking at a specific period of time
Rate of Abstinence
Time frame: week 4
number of patient that have been quick smoking at a specific period of time
Rate of Abstinence
Time frame: week 6
number of patient that have been quick smoking at a specific period of time
Rate of Abstinence
Time frame: week 8
number of patient that have been quick smoking at a specific period of time
Rate of Abstinence
Time frame: week 10
number of patient that have been quick smoking at a specific period of time
Rate of Abstinence
Time frame: week 12
number of patient that have been quick smoking at a specific period of time
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
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
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
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
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
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
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
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
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
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
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
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
Level of blood nicotine
Time frame: week 6
Level of blood nicotine
Level of blood nicotine
Time frame: week 12
Level of blood nicotine
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
Time frame: week 12
level of n-acetylaspartate in Magnetic Resonance Spectroscopy (MRS) study
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
Time frame: week 12
level of glutamate in Magnetic Resonance Spectroscopy (MRS) study
1 secondary outcome
Side Effect of n-acetylcysteine consumption
Time frame: every 2 weeks for 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 19109354Mottillo 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.
- Background: PubMed 21606648Schmaal 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.
- Background: PubMed 25729878Prado 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.
- Background: PubMed 28922968Schulte 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.
- Background: PubMed 32725102Machado 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.
- Background: PubMed 26454838Froeliger 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.
- Background: PubMed 25062287McClure 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.
- Background: PubMed 25384734Bernardo 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.
- Background: PubMed 19103434Knackstedt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing n-acetylcysteine and Motivational Enhancement Therapy in people with Nicotine Dependence and Nicotine Addiction, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Abstinence (time frame: week 2). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05903014, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.