Amphetamine Use DisordersNCT06960265
Effects of Repetitive Transcranial Magnetic Stimulations in Patients With Amphetamine Use Disorders
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Amphetamine Use Disorders and Amphetamine Use Disorder, run by TsaoTun Psychiatric Center, Department of Health, Taiwan at 1 site in Taiwan.
Trial summary
Amphetamine Use Disorder (AUD) is a major public health issue in Taiwan, where it is the most commonly abused illegal drug. There are currently no effective approved medications to treat it, which makes finding new treatment options urgent. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Amphetamine Use Disorders, Amphetamine Use Disorder, Amphetamine Dependence
- What is being tested?
- repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20 years.
- Meeting DSM-5 criteria for substance use disorder made by a specialist in addiction psychiatry.
- Fluency in Chinese.
- Willingness and ability to comply with study requirements.
- Good physical health determined by complete physical examination, and laboratory tests.
- Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
- Trained psychiatrists will assess eligible patients using the structured clinical interview for the Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al., 1998) to determine the presence of any psychotic disorder.
Who cannot join
- Evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation.
- Premorbid mental retardation.
- Other major Axis-I Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnoses other than substance use disorder.
- Pregnancy or nursing.
- History of seizures or epilepsy.
- History of neurological diseases or traumatic brain injury.
- Suicidal attempts or risks during screening or study period.
- Presence of prosthesis devices, e.g. pace-makers, cochlear prosthesis, neuro- stimulators, magnetic cochlear prosthesis, intraocular metallic fragments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
TsaoTun Psychiatric Center
Nantou City
Ching-Hua Julie Lee, MD., MPH, +886-49-2550800, juliechlee77@gmail.com
About this study
Official title: A Pilot Study for the Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Amphetamine Use Disorders: Clinical Outcomes, Near InfraRed Spectroscopy, and Biomarkers
Amphetamine Use Disorder (AUD) is a major public health issue in Taiwan, where it is the most commonly abused illegal drug. There are currently no effective approved medications to treat it, which makes finding new treatment options urgent. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation method, has shown promise in reducing cravings and drug use in people with addiction, but its effects on AUD are not well studied.
To explore this, the investigators plan to conduct a double-blind, sham-controlled study with 20 people diagnosed with AUD. Half will receive real rTMS treatment, and half will receive a placebo-like sham treatment. The treatment targets a specific brain area (the left dorsolateral prefrontal cortex) and will be given 10 times over two weeks.
Read more
The investigators will assess the effectiveness of rTMS by tracking drug cravings, urine test results, and side effects with follow-up over 12 weeks. The investigators also include brain imaging using near-infrared spectroscopy (NIRS) after the treatment.
The study aims to better understand how rTMS might help reduce amphetamine cravings and improve outcomes, potentially leading to new treatment options for AUD.
Read the detailed description
Amphetamine Use Disorder (AUD) is a serious and growing public health concern, especially in Taiwan, where amphetamines are the most commonly misused illegal drugs. Globally, amphetamines also rank among the top drugs of abuse. Despite the widespread impact of this condition, there are currently no approved medications that effectively treat amphetamine addiction. This gap in treatment options underscores the urgent need for new and innovative approaches to help individuals struggling with AUD.
One promising method being explored is Repetitive Transcranial Magnetic Stimulation (rTMS). This is a non-invasive technique that uses magnetic fields to stimulate specific areas of the brain. It has already shown positive effects in treating several mental health conditions, such as depression and anxiety, and early studies suggest it may also help reduce cravings and drug use in people with substance use disorders.
This study aims to investigate whether rTMS can help people with AUD by reducing their cravings and improving their chances of recovery. To do this, the investigators will conduct a carefully controlled clinical trial involving 20 participants who have been diagnosed with AUD. The participants will be randomly divided into two groups. One group will receive active rTMS treatment, while the other will receive a "sham" or placebo version of the treatment. This means the second group will undergo the same procedure without the magnetic stimulation, allowing us to accurately measure the true effects of rTMS.
The treatment will focus on a brain area called the left dorsolateral prefrontal cortex (DLPFC), which is involved in decision-making, impulse control, and craving regulation. The rTMS sessions will use a high-frequency setting (15 Hz) delivered in short bursts, with a total of 10 sessions spread over two weeks.
To understand the impact of the treatment, the investigators will collect several types of data from participants throughout the study (pre and post) and for 12 weeks afterward. This includes:
Urine drug tests to check for ongoing amphetamine use Craving assessments to see if the urge to use drugs decreases Monitoring for side effects to ensure safety Neuropsychological tests to assess changes in thinking and behavior Brain imaging using near-infrared spectroscopy (NIRS) to observe changes in brain activity Through this comprehensive approach, the investigators hope to learn more about how rTMS works in the context of amphetamine addiction and whether it could be developed into an effective treatment. The findings could pave the way for new, science-based therapies to support individuals with AUD and reduce the burden of this condition on individuals, families, and society.
- Conditions
- Amphetamine Use Disorders, Amphetamine Use Disorder, Amphetamine Dependence, Amphetamine Abuse, NIRS, rTMS
- Being tested
- repetitive Transcranial Magnetic Stimulation (rTMS), sham for repetitive Transcranial Magnetic Stimulation
- Keywords
- amphetamine, rtms, NIRS
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic Stimulation (rTMS)Device
Targeting: The left dorsolateral prefrontal cortex (DLPFC) will be the target for treatment.
Equipment: rTMS will be delivered using a Magstim super rapid magnetic stimulator with a 70-mm air-cooled figure-eight-shaped coil. Resting Motor Threshold (rMT) Measurement: rMT is determined through visual twitch responses in the contralateral hand, identifying the minimal intensity needed to elicit thumb movement in 50% of trials.
rTMS will be administered at a frequency of 15Hz, with each pulse at 100% rMT intensity. Sessions include 60 pulses per train, with a 26-second inter-train pause, across 40 trains, totaling 2400 pulses over a 20-minute session.
sham for repetitive Transcranial Magnetic StimulationDevice
The sham group will undergo a placebo procedure using the same rTMS parameters but with a figure-of-eight sham coil, following precedents set by studies on cocaine use disorder treatment (Terraneo et al., 2016).
| Study group | Role | What they receive |
|---|---|---|
| Controlled | Sham comparator | The sham group will undergo a placebo procedure using the same rTMS parameters but with a figure-of-eight sham coil, following precedents set by studies on cocaine use disorder treatment (Terraneo et al., 2016). Receives: Device: sham for repetitive Transcranial Magnetic Stimulation |
| rTMS treatment group | Experimental | rTMS will be administered at a frequency of 15Hz, with each pulse at 100% rMT intensity. Sessions include 60 pulses per train, with a 26-second inter-train pause, across 40 trains, totaling 2400 pulses over a 20-minute session. Schedule: Participants will receive daily rTMS sessions for the first five days, followed by 5 more sessions for the second week, totaling 10 sessions Receives: Device: repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Hb level using Near-infrared spectroscopy (NIRS)
NIRS will focus on oxy-Hb and deoxy-Hb of frontal lobe and left and right sides frontal lobe. Later the average Hb will be calculated for frontal lobe and left and right sides frontal lobe.
Measured: From enrollment to the end of treatment at 2 weeks.
Urine Drug Test
Urine drug tests to check for ongoing amphetamine use
Measured: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Secondary outcomes (8)
Amphetamine Dependence Level
Severity of Dependence Scale (SDS) (V. C. H. Chen et al., 2008)
Measured: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Amphetamine Craving Level
Craving Scale: Includes the Drug-Use and Craving Questionnaire (Huang et al., 2021)
Measured: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Impulsivity Level
Barratt Impulsiveness Scale (BIS-11) (Patton et al., 1995)
Measured: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Level for Quality of Life
WHO Quality of Life instrument - BREF (WHOQOL-BREF) (Yao et al., 2002)
Measured: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Anxiety Level
General Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006)
Measured: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Depression Level
Chinese Version of the Centre for Epidemiologic Studies Depression Scale (CESD- C) (Cheng \& Chan, 2005; Radloff, 1977)
Measured: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Erectile Function
International Index of Erectile Function (IIEF-5) (Rosen et al., 1998)
Measured: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Suicidality
Ask Suicide-Screening Questions (ASQ) (Horowitz et al., 2012)
Measured: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start15 May 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine Use DisordersStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TsaoTun Psychiatric Center, Department of Health, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ching-Hua Julie Lee, TsaoTun Psychiatric Center, Department of Health, Taiwan
- Investigators
- Ching-Hua Julie Lee, MD., MPH, Principal investigator, Tsaotun Psychiatric Center, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960265
- Sponsor's protocol ID
- 11457
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Amphetamine Use Disorders: Clinical Outcomes, Near InfraRed Spectroscopy, and Biomarkers
- ClinicalTrials.gov ID
- NCT06960265
- Acronym / sponsor ID
- 11457
- Conditions
- Amphetamine Use Disorders, Amphetamine Use Disorder, Amphetamine Dependence, Amphetamine Abuse, NIRS, rTMS
- Keywords
- amphetamine, rtms, NIRS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TsaoTun Psychiatric Center, Department of Health, TaiwanUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 May 2025 (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.
Amphetamine Use Disorder (AUD) is a major public health issue in Taiwan, where it is the most commonly abused illegal drug. There are currently no effective approved medications to treat it, which makes finding new treatment options urgent. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation method, has shown promise in reducing cravings and drug use in people with addiction, but its effects on AUD are not well studied.
To explore this, the investigators plan to conduct a double-blind, sham-controlled study with 20 people diagnosed with AUD. Half will receive real rTMS treatment, and half will receive a placebo-like sham treatment. The treatment targets a specific brain area (the left dorsolateral prefrontal cortex) and will be given 10 times over two weeks.
The investigators will assess the effectiveness of rTMS by tracking drug cravings, urine test results, and side effects with follow-up over 12 weeks. The investigators also include brain imaging using near-infrared spectroscopy (NIRS) after the treatment.
The study aims to better understand how rTMS might help reduce amphetamine cravings and improve outcomes, potentially leading to new treatment options for AUD.
Detailed description
Amphetamine Use Disorder (AUD) is a serious and growing public health concern, especially in Taiwan, where amphetamines are the most commonly misused illegal drugs. Globally, amphetamines also rank among the top drugs of abuse. Despite the widespread impact of this condition, there are currently no approved medications that effectively treat amphetamine addiction. This gap in treatment options underscores the urgent need for new and innovative approaches to help individuals struggling with AUD.
One promising method being explored is Repetitive Transcranial Magnetic Stimulation (rTMS). This is a non-invasive technique that uses magnetic fields to stimulate specific areas of the brain. It has already shown positive effects in treating several mental health conditions, such as depression and anxiety, and early studies suggest it may also help reduce cravings and drug use in people with substance use disorders.
This study aims to investigate whether rTMS can help people with AUD by reducing their cravings and improving their chances of recovery. To do this, the investigators will conduct a carefully controlled clinical trial involving 20 participants who have been diagnosed with AUD. The participants will be randomly divided into two groups. One group will receive active rTMS treatment, while the other will receive a "sham" or placebo version of the treatment. This means the second group will undergo the same procedure without the magnetic stimulation, allowing us to accurately measure the true effects of rTMS.
The treatment will focus on a brain area called the left dorsolateral prefrontal cortex (DLPFC), which is involved in decision-making, impulse control, and craving regulation. The rTMS sessions will use a high-frequency setting (15 Hz) delivered in short bursts, with a total of 10 sessions spread over two weeks.
To understand the impact of the treatment, the investigators will collect several types of data from participants throughout the study (pre and post) and for 12 weeks afterward. This includes:
Urine drug tests to check for ongoing amphetamine use Craving assessments to see if the urge to use drugs decreases Monitoring for side effects to ensure safety Neuropsychological tests to assess changes in thinking and behavior Brain imaging using near-infrared spectroscopy (NIRS) to observe changes in brain activity Through this comprehensive approach, the investigators hope to learn more about how rTMS works in the context of amphetamine addiction and whether it could be developed into an effective treatment. The findings could pave the way for new, science-based therapies to support individuals with AUD and reduce the burden of this condition on individuals, families, and society.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled | Sham comparator | Device: sham for repetitive Transcranial Magnetic StimulationThe sham group will undergo a placebo procedure using the same rTMS parameters but with a figure-of-eight sham coil, following precedents set by studies on cocaine use disorder treatment (Terraneo et al., 2016). |
| rTMS treatment group | Experimental | Device: repetitive Transcranial Magnetic Stimulation (rTMS)rTMS will be administered at a frequency of 15Hz, with each pulse at 100% rMT intensity. Sessions include 60 pulses per train, with a 26-second inter-train pause, across 40 trains, totaling 2400 pulses over a 20-minute session. Schedule: Participants will receive daily rTMS sessions for the first five days, followed by 5 more sessions for the second week, totaling 10 sessions |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥20 years.
- Meeting DSM-5 criteria for substance use disorder made by a specialist in addiction psychiatry.
- Fluency in Chinese.
- Willingness and ability to comply with study requirements.
- Good physical health determined by complete physical examination, and laboratory tests.
Key exclusion criteria (8 listed)
- Evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation.
- Premorbid mental retardation.
- Other major Axis-I Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnoses other than substance use disorder.
- Pregnancy or nursing.
- History of seizures or epilepsy.
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 |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation (rTMS)Targeting: The left dorsolateral prefrontal cortex (DLPFC) will be the target for treatment. Equipment: rTMS will be delivered using a Magstim super rapid magnetic stimulator with a 70-mm air-cooled figure-eight-shaped coil. Resting Motor Threshold (rMT) Measurement: rMT is determined through visual twitch responses in the contralateral hand, identifying the minimal intensity needed to elicit thumb movement in 50% of trials. rTMS will be administered at a frequency of 15Hz, with each pulse at 100% rMT intensity. Sessions include 60 pulses per train, with a 26-second inter-train pause, across 40 trains, totaling 2400 pulses over a 20-minute session. | Device | rTMS treatment group |
| sham for repetitive Transcranial Magnetic StimulationThe sham group will undergo a placebo procedure using the same rTMS parameters but with a figure-of-eight sham coil, following precedents set by studies on cocaine use disorder treatment (Terraneo et al., 2016). | Device | Controlled |
Primary outcome
Average Hb level using Near-infrared spectroscopy (NIRS)
Time frame: From enrollment to the end of treatment at 2 weeks.
NIRS will focus on oxy-Hb and deoxy-Hb of frontal lobe and left and right sides frontal lobe. Later the average Hb will be calculated for frontal lobe and left and right sides frontal lobe.
Urine Drug Test
Time frame: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Urine drug tests to check for ongoing amphetamine use
8 secondary outcomes
Amphetamine Dependence Level
Time frame: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Amphetamine Craving Level
Time frame: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Impulsivity Level
Time frame: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Level for Quality of Life
Time frame: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Anxiety Level
Time frame: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Depression Level
Time frame: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Erectile Function
Time frame: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Suicidality
Time frame: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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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.
Ching-Hua Julie Lee, MD., MPH principal investigator
Tsaotun Psychiatric Center, Ministry of Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Amphetamine Use Disorders and Amphetamine Use Disorder, run by TsaoTun Psychiatric Center, Department of Health, Taiwan at 1 site in Taiwan.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 7 May 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Hua Julie Lee, MD., MPH (+886921329989, juliechlee77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Hb level using Near-infrared spectroscopy (NIRS) (time frame: From enrollment to the end of treatment at 2 weeks.). The study lists 2 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 7 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.