Repetitive Transcranial Magnetic Stimulation in Patients With Opioid Use Disorders
Transcranial Magnetic Stimulation, Heroin Dependence
About this trial
This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring repetitive transcranial magnetic stimulation, opioid use disorder, craving, functional magnetic resonance imaging, neuropsychological tests
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent by patient or legal representative.
- Male or female patient aged ≧20 and ≦65 years.
- A diagnosis of OUD according to DSM criteria made by a specialist in psychiatry.
- Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
Exclusion Criteria:
- Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study.
- Females who are pregnant or lactation.
- Current 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.
- History of seizure or epilepsy.
- History of neurological diseases or traumatic brain injury.
- Suicidal attempts or risks during screen or study period.
- Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators, magnetic cochlear prosthesis, intraocular metallic fragments.
- Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first intervention of the double-blinded treatment.
Sites / Locations
- National Cheng Kung University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active rTMS treatment
Sham rTMS treatment
The rTMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions.
The rTMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min, with a figure-of-eight sham coil. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions.