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CompletedPhase 4

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

Key facts

Who runs it
Universitas Indonesia
Where
Indonesia1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 4
People taking part
90 people enrolled
Started
1 Jan 2023
Ended
30 Dec 2023
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • n-acetylcysteine
  • Motivational Enhancement Therapy
Record updated
8 October 2024

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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 take part

  • 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • ExperimentalTreatment being tested

    3600 mg NAC per day in 12 weeks

    Treatment: n-acetylcysteine and Motivational Enhancement Therapy

  • PlaceboPlacebo, for comparison

    Treatment: Motivational Enhancement Therapy

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
8 October 2024