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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTsaoTun Psychiatric Center, Department of Health, Taiwan

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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 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).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: ControlledSham comparator 1 intervention
Group B: rTMS treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 2 weeks.
2

Urine Drug Test

Urine drug tests to check for ongoing amphetamine use

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

Secondary outcomes

1

Amphetamine Dependence Level

Severity of Dependence Scale (SDS) (V. C. H. Chen et al., 2008)

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

Amphetamine Craving Level

Craving Scale: Includes the Drug-Use and Craving Questionnaire (Huang et al., 2021)

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

Impulsivity Level

Barratt Impulsiveness Scale (BIS-11) (Patton et al., 1995)

Time frame
From enrollment to the end of treatment at 2 weeks and at 3 months follow up.
4

Level for Quality of Life

WHO Quality of Life instrument - BREF (WHOQOL-BREF) (Yao et al., 2002)

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

Other outcomes

Sponsors and contacts

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