the Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients

Study Overview
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Brief Summary
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Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue. Administering high frequency rTMS to the left dorsolateral prefrontal cortex is possible to increase brain activity in the stimulated area and to change brain activity in associated regions that are part of the same neural circuit which may reduce craving.

Official Title
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The Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Device: repetitive trans magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range: 18-45 years old Gender: males Opioid Use disorder according to the DSM-5 (early abstinence starting 1 week up to 1 month). Exclusion Criteria: Presence of other serious mental illness (e.g.; psychotic disorders, bipolar affective disorder, depression with psychotic features). Patients with any other serious medical illness. Previous treatment with repetitive Trans- cranial magnetic stimulation. Patients with contraindications to rTMS as cardiac patient with pacemaker.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1, Active intervention group<br> | Device: repetitive trans magnetic stimulation<br>* Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue.<br>* Other names: r-TMS;|
| Sham Comparator: group 2, sham controlled group<br> | Device: repetitive trans magnetic stimulation<br>* Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue.<br>* Other names: r-TMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| craving severity | measure severity of drug craving using craving severity scale, the scale is called brief substance craving scale. a higher outcome is a worse result | 6 weeks | 
| heroin craving | using the heroin craving questionnaire, a higher score indicates a worse outcome | 6 weeks |