About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
repetitive Transcranial Magnetic Stimulation (rTMS)
DeviceTargeting: 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 Stimulation
DeviceThe 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).
Treatment groups
Trial outcomes
Primary outcomes
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.
Urine Drug Test
Urine drug tests to check for ongoing amphetamine use
Secondary outcomes
Amphetamine Dependence Level
Severity of Dependence Scale (SDS) (V. C. H. Chen et al., 2008)
Amphetamine Craving Level
Craving Scale: Includes the Drug-Use and Craving Questionnaire (Huang et al., 2021)
Impulsivity Level
Barratt Impulsiveness Scale (BIS-11) (Patton et al., 1995)
Level for Quality of Life
WHO Quality of Life instrument - BREF (WHOQOL-BREF) (Yao et al., 2002)
Sponsors and contacts
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