Effects of Repetitive Transcranial Magnetic Stimulations in Patients With Amphetamine Use Disorders (NCT06960265) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Repetitive Transcranial Magnetic Stimulations in Patients With Amphetamine Use Disorders
Taiwan20 participantsStarted 2025-05-15
Plain-language 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. 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Hb level using Near-infrared spectroscopy (NIRS)
Timeframe: From enrollment to the end of treatment at 2 weeks.
2
Urine Drug Test
Timeframe: From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
Trial details
NCT IDNCT06960265
SponsorTsaoTun Psychiatric Center, Department of Health, Taiwan