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

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

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.

Study Overview

• Status: Completed
• Conditions: Transcranial Magnetic Stimulation; Methamphetamine Use Disorder; Theta Burst Stimulation
• Intervention / Treatment: Device: Theta Burst Stimulation; Behavioral: Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Special Capital Region
    • Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430
      • Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TBS and CBT; During 12 days of intervention, the participants underwent 10 sessions of TBS and 12 sessions for CBT.	Device: Theta Burst Stimulation; A randomized controlled trial (RCT) of 20 participants underwent TBS and CBT intervention for MUD.; Other Names: TMS; Transcranial Magnetic Stimulation; TBS; Behavioral: Cognitive Behavioral Therapy; 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
Sham Comparator: Sham and CBT; During 12 days of intervention, the participants underwent 10 sessions of sham TBS and 12 sessions of CBT.	Device: Theta Burst Stimulation; A randomized controlled trial (RCT) of 20 participants underwent TBS and CBT intervention for MUD.; Other Names: TMS; Transcranial Magnetic Stimulation; TBS; Behavioral: Cognitive Behavioral Therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in craving for methamphetamine	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.	Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)
Improvement in craving (tonic) for methamphetamine	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.	Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)
Improvement in clinical severity	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.	Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Addiction Severity	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.	Baseline (T1) and Post-Intervention Day 12 (T6)
Improvement in Depressive Symptoms	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.	Baseline (T1) and Post-Intervention Day 12 (T6)
Improvement in Motivation to Change	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.	Baseline (T1) and Post-Intervention Day 12 (T6)
Improvement in Impulsivity	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.	Baseline (T1) and Post-Intervention Day 12 (T6)
Improvement in Sleep Quality	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.	Baseline (T1) and Post-Intervention Day 12 (T6)

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2025
• Primary Completion (Actual): November 3, 2025
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; Cognitive Behavioral Therapy; Theta Burst Stimulation; Methamphetamine Use Disorder
• Additional Relevant MeSH Terms: Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Magnetic Field Therapy; Cognitive Behavioral Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: KET-741-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No