Opioid Use Disorder Clinical Trial
Official title:
Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
Deep TMS to the left dorsolateral prefrontal cortex intervention to reduce craving and recurrent opioid use among patients with opioid use disorder who are abstinent for at least one week.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 18- 65 - Clinical diagnosis of opioid use disorder Exclusion Criteria: - Currently pregnant or breastfeeding - Mental retardation, bipolar disorder, any psychotic disorder - Neurological diseases such as epilepsy, ischemic stroke, multiple sclerosis - History of head trauma that resulted in loss of consciousness for =5 minutes and retrograde amnesia for =30 minutes (self-reported history) - Any history of seizures other than febrile childhood seizures (self-reported history) - Clinically significant hearing impairment - Having any prosthesis, such as an implant and pacemaker. - Illiteracy |
Country | Name | City | State |
---|---|---|---|
Turkey | Bengu Yucens | Denizli |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | craving | craving severity for drug use- Visual Analog Scale (VAS). The minimum and maximum values are 0-10. Higher scores mean a worse outcome. | pretreatment, 2 weeks, and 8 weeks | |
Secondary | Impulsivity severity | The Barratt Impulsiveness Scale-11 (BIS). The minimum and maximum scores are 30-120. Higher scores mean a worse outcome. | pretreatment, 2 weeks, and 8 weeks | |
Secondary | Depression severity | The Hamilton Depression Rating Scale. The minimum and maximum scores are 0-52. Higher scores mean a worse outcome. | pretreatment, 2 weeks, and 8 weeks | |
Secondary | Anxiety severity | Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome. | pretreatment, 2 weeks, and 8 weeks | |
Secondary | Opioid use | opioid metabolite in urine. | 8 weeks of treatment |
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