Methamphetamine Use DisorderNCT07399431
Theta Burst Stimulation in the Management of Methamphetamine Use Disorder in Indonesia
A study testing Theta Burst Stimulation and Cognitive Behavioral Therapy in people with Methamphetamine Use Disorder and Theta Burst Stimulation, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Methamphetamine Use Disorder, Theta Burst Stimulation, Transcranial Magnetic Stimulation
- What is being tested?
- Theta Burst Stimulation and Cognitive Behavioral Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Mar 2026to 12 Jun 2026
- Phase
- Interventional
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official 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
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.
- Being tested
- Theta Burst Stimulation, Cognitive Behavioral Therapy
- Keywords
- Methamphetamine Use Disorder, Theta Burst Stimulation, Cognitive Behavioral Therapy, Transcranial Magnetic Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta Burst StimulationDevice
Also called TBS, Transcranial Magnetic Stimulation, TMS
A randomized controlled trial (RCT) of 20 participants underwent TBS and CBT intervention for MUD.
Cognitive Behavioral TherapyBehavioural
Also called CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| TBS and CBT | Experimental | During 12 days of intervention, the participants underwent 10 sessions of TBS and 12 sessions for CBT. Receives: 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. Receives: Device: Theta Burst Stimulation; Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T1) and Post-Intervention Day 12 (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start23 Mar 2026
- Primary completion10 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristiana Siste, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399431
- Sponsor's protocol ID
- KET-741-2025
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07399431
- Acronym / sponsor ID
- KET-741-2025
- Keywords
- Methamphetamine Use Disorder, Theta Burst Stimulation, Cognitive Behavioral Therapy, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 10 Feb 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBS and CBT | Experimental | Device: Theta Burst Stimulation, Behavioral: Cognitive Behavioral TherapyDuring 12 days of intervention, the participants underwent 10 sessions of TBS and 12 sessions for CBT. |
| Sham and CBT | Sham comparator | Device: Theta Burst Stimulation, Behavioral: Cognitive Behavioral TherapyDuring 12 days of intervention, the participants underwent 10 sessions of sham TBS and 12 sessions of CBT. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Theta Burst StimulationAlso: TBS, Transcranial Magnetic Stimulation, TMSA randomized controlled trial (RCT) of 20 participants underwent TBS and CBT intervention for MUD. | Device | Sham and CBT, TBS and CBT |
| Cognitive Behavioral TherapyAlso: CBTThe 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. | Behavioural | Sham and CBT, TBS and CBT |
Primary outcome
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.
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.
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.
5 secondary outcomes
Improvement in Addiction Severity
Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)
Improvement in Depressive Symptoms
Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)
Improvement in Motivation to Change
Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)
Improvement in Impulsivity
Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)
Improvement in Sleep Quality
Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)
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 16 Sep 2026.
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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 study testing Theta Burst Stimulation and Cognitive Behavioral Therapy in people with Methamphetamine Use Disorder and Theta Burst Stimulation, 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 3 inclusion and 4 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 16 Sep 2026. 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.
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?
Improvement in craving for methamphetamine (time frame: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.