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

NCT07399431 | Completed

• 1 other identifier: KET-741-2025
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Use Disorder; Theta Burst Stimulation; Transcranial Magnetic Stimulation

Keywords

Methamphetamine Use Disorder; Theta Burst Stimulation; Cognitive Behavioral Therapy; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Improvement in Addiction Severity

  Baseline (T1) and Post-Intervention Day 12 (T6)

• Improvement in Depressive Symptoms

  Baseline (T1) and Post-Intervention Day 12 (T6)

• Improvement in Motivation to Change

  Baseline (T1) and Post-Intervention Day 12 (T6)

• Improvement in Impulsivity

  Baseline (T1) and Post-Intervention Day 12 (T6)

• Improvement in Sleep Quality

  Baseline (T1) and Post-Intervention Day 12 (T6)

Study Arms (2)

TBS and CBT

EXPERIMENTAL

During 12 days of intervention, the participants underwent 10 sessions of TBS and 12 sessions for CBT.

Device: Theta Burst Stimulation; Behavioral: Cognitive Behavioral Therapy

Sham and CBT

SHAM COMPARATOR

During 12 days of intervention, the participants underwent 10 sessions of sham TBS and 12 sessions of CBT.

Device: Theta Burst Stimulation; Behavioral: Cognitive Behavioral Therapy

Interventions

Theta Burst Stimulation DEVICE

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

Also known as: TBS, Transcranial Magnetic Stimulation, TMS

Sham and CBT; TBS and CBT

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.

Also known as: CBT

Sham and CBT; TBS and CBT

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation; Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. dr. Kristiana Siste, Sp.KJ(K) - Head of Department of Psychiatry, Cipto Mangunkusumo General Hospital

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 10, 2026
• Study Start: October 19, 2025
• Primary Completion: November 3, 2025
• Study Completion: November 5, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

ID (1)