Effects of Repetitive Transcranial Magnetic Stimulations in Patients With Amphetamine Use Disorders

NCT06960265 | Not Yet Recruiting

• 1 other identifier: 11457
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amphetamine Use Disorders; Amphetamine Use Disorder; Amphetamine Dependence; Amphetamine Abuse; NIRS; rTMS; rTMS Stimulation

Keywords

amphetamine; rtms; NIRS

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of treatment at 2 weeks.

• Urine Drug Test

  Urine drug tests to check for ongoing amphetamine use

  From enrollment to the end of treatment at 2 weeks and at 3 months follow up.

Secondary Outcomes (8)

• Amphetamine Dependence Level

  From enrollment to the end of treatment at 2 weeks and at 3 months follow up.

• Amphetamine Craving Level

  From enrollment to the end of treatment at 2 weeks and at 3 months follow up.

• Impulsivity Level

  From enrollment to the end of treatment at 2 weeks and at 3 months follow up.

• Level for Quality of Life

  From enrollment to the end of treatment at 2 weeks and at 3 months follow up.

• Anxiety Level

  From enrollment to the end of treatment at 2 weeks and at 3 months follow up.

Study Arms (2)

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).

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

Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

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.

rTMS treatment group

sham for repetitive Transcranial Magnetic Stimulation DEVICE

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).

Controlled

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TsaoTun Psychiatric Center, Department of Health, Taiwan: lead

Study Sites (1)

TsaoTun Psychiatric Center

Nantou City, Taiwan

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Ching-Hua Julie Lee, MD., MPH

  Tsaotun Psychiatric Center, Ministry of Health and Welfare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Hua Julie Lee, MD., MPH

CONTACT

+886921329989; juliechlee77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychiatrist

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: May 7, 2025
• Study Start: May 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)