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Completed

NCT Number: NCT07399431

Theta Burst Stimulation in the Management of Methamphetamine Use Disorder in Indonesia

Methamphetamine use disorder (MUD) remains a major public health concern in Indonesia, with limited effective treatment options and high relapse rates. Theta Burst Stimulation (TBS) has emerged as a promising adjunctive intervention for reducing craving and improving clinical outcomes. This trial aims to evaluate the efficacy and safety of TBS for MUD. A RCT of 20 subjects was conducted to evalute the efficacy and safety of TBS as an adjunctive treatment to CBT in managing MUD.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged 18-59 years old
  • Subjects diagnosed with methamphetamine use disorder without having undergone treatment, whether psychotherapy and/or psychopharmacological modalities
  • Subjects are able to read and write

Exclusion criteria

  • Subjects with severe thought process disorders, impaired perception, restless condition, severe neurological disorders, history of neuromodulation,
  • Subjects refused to participate in the study
  • Subjects who are pregnant
  • Subjects who have radioactive implants

Treatment and study plan

Theta Burst Stimulation

Device

A randomized controlled trial (RCT) of 20 participants underwent TBS and CBT intervention for MUD.

Other names: TBS, Transcranial Magnetic Stimulation, TMS

Cognitive behavioral therapy

Behavioral

The cognitive behavioral therapy (CBT) for methamphetamine use disorder (MUD) was conducted in 12 sessions (1 session per day). We utilized the module adapted from the Indonesia Drug Addiction and Relapse Prevention Program (Indo-DARPP) for MUD. The CBT was delivered by trained psychiatrist in group CBT setting.

Other names: CBT

Primary outcomes

  1. Improvement in craving for methamphetamine

    Time frame: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)

    Cue-induced craving was measured with Visual Analog Scale (VAS) where the patient told to indicate their point of craving in a 100 mm line. The scale ranged from 0 to 10, with higher scores indicated higher craving.

  2. Improvement in craving (tonic) for methamphetamine

    Time frame: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)

    Tonic or baseline craving was measured using the Questionnaire for Smoking Urges modified for Methamphetamine (QSU-M) in Indonesian version. The questions were self-filled by the participants to identify their level of craving. The QSU-M is a 7-point Likert Scale (1 was strongly disagree and 7 was strongly agree) with the higher total scores indicating higher tonic craving. The total minimum score was 10 while the maximum score was 70.

  3. Improvement in clinical severity

    Time frame: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)

    The clinical severity was measured using the Clinical Global Impression - Severity by the psychiatrist based on the patient's condition during the day of examination. CGI is a clinician-rated instrument used to assess the patient's condition based on clinical judgment. CGI mainly rates the severity of illness assessed using a 7-point Likert scale, ranges from 1 (normal) to 7 (among the most extremely ill). Higher score indicated higher severity of addiction-related illness.

Secondary outcomes

  1. Improvement in Addiction Severity

    Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)

    Addiction Severity Index (ASI) assessed the severity of a person's addiction, through multiple domains; medical, occupational, alcohol usage, substance use, law, family/social and mental status domains. The analysis utilized composite scores of relevant questions. Higher scores indicated higher severity. The minimum composite score for each domain was 0 while the maximum score was 1.

  2. Improvement in Depressive Symptoms

    Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)

    The Patient Health Questionnaire-9 (PHQ-9) assessed the severity of depressive symptoms, with higher scores indicating higher severity. PHQ-9 is a 9 item with 3-point Likert scale with 0 indicates no presence of symptoms and indicates higher frequency of depression symptoms (nearly every day). The higher total scores indicates higher severity of depression, with the minimum total score of 0 and the maximum score of 27.

  3. Improvement in Motivation to Change

    Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)

    University of Rhode Island Change Assessment (URICA) assessed a person's readiness for change, with scores divided into four subscales: pre-contemplation, contemplation, action and maintenance. URICA is a five-point Likert scale consisting of 32 questions, ranges from 1 (strongly disagree) to 5 (strongly agree). The minimum averaged score per subscale was 1 while the maximum score was 5. The calculation was done with the formula as follow: (averaged contemplation + averaged action + averaged maintenance)/averaged pre-contemplation.

    Higher overall score indicated higher stage of change.

  4. Improvement in Impulsivity

    Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)

    The Barratt Impulsiveness Scale version 11 (BIS-11) assesed impulsive attitudes and behaviors. BIS-11 was a four-point Likert scales of 30 items, ranged from 1 (never/very rarely), 2 (rarely), 3 (often), and 4 (almost always). The total scores ranged from 30 to 120. Higher scores indicate higher overall impulsivity.

  5. Improvement in Sleep Quality

    Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)

    The Pittsburgh Sleep Quality Index (PSQI) assessed sleep quality, measuring subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. PSQI consisted of different segments of questions from sleep duration, habitual efficiency, and symptoms of sleeping problems. The symptoms were measured in 4-point Likert scale where 0 indicated no difficulty and 3 indicated high difficulty of sleeping. This instrument consisted of 19 questions, yielding a global score from 0 to 21. A higher total score indicated poor sleep quality.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effectiveness of Theta Burst Stimulation in the Management of Methamphetamine Use Disorder in Indonesia: A Randomized Controlled Trial as a National Model for Comprehensive Management

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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