Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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The participants will undergo baseline assessments, including rating scales and urine opioid metabolite tests. The participants will receive one of two treatments: High-frequency (10Hz, 3000 pulses per session) dTMS using a double cone coil targeting the left dorsolateral prefrontal cortex or sham stimulation. Each treatment will be preceded by a short-guided imagery (2-3 min) design to activate the relevant brain circuitry (provocation of symptoms may increase the response rate to deep TMS as was evident in the treatment of PTSD, cigarette smoking, and OCD). dTMS sessions will be conducted 10 times per week for 2 weeks, for 20 sessions. 8 weeks of patient follow-up, including clinical visits at weeks 0, 2, and 8. During this phase, subjective and objective measures of opioid use (self-report and analysis of urine samples for opioid metabolite) will be collected. Following the completion of the main part by the individual, an open-label treatment using the same parameters of the experiment will be offered (regardless of the treatment group).

Official Title
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Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Device: Transcranial Magnetic Stimulation with double-cone coil
* Device: Transcranial Magnetic Stimulation with sham coil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active TMS<br>Deep TMS to the left dorsolateral prefrontal cortex with double-cone coil | Device: Transcranial Magnetic Stimulation with double-cone coil<br>* Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil<br>|
| Sham Comparator: Sham TMS<br>Sham TMS to the left dorsolateral prefrontal cortex with sham coil | Device: Transcranial Magnetic Stimulation with sham coil<br>* Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Opioid use | opioid metabolite in urine. | 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation, Opioid Use Disorder