Role of High Frequency RTMS in Management of Opioid Use Disorder

NCT06689072 | Enrolling By Invitation

• 2 other identifiers: RTMS in opioid patients in EgyAssiut University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the role of repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) in reducing pain, decreasing craving, alleviating withdrawal symptoms, lowering relapse rates, reducing impulsivity, and improving cognitive function in patients with Opioid Use Disorder, while also evaluating associated factors.

Conditions

Addiction; Opioid; RTMS

Keywords

Addiction; Opioid; rTMS; Egypt

Outcome Measures

Primary Outcomes (3)

• Role of rTMS in managing opioid use disorders using multiple scales

  To evaluate the role of repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) in reducing pain in patients with Opioid Use Disorder by using BRIEF PAIN INVENTORY (SHORT FORM) scale.

  2 years

• RTMS in managing opioid use disorder in Upper Egypt

  Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) in reducing craving in opioid use disorder patient using Brief Substance Craving Scale.

  2 years

• RTMS in managing opioid use disorder in Upper Egypt

  Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) in improving cognition using Montreal Cognitive Assessment (MoCA) scale.

  2 years

Study Arms (2)

Opioid Group

ACTIVE COMPARATOR

Participants diagnosed with Opioid use disorder

Other: rTMS

Control Group

SHAM COMPARATOR

Participants who do not have Opioid use disoder

Behavioral: Psychotherapy

Interventions

rTMS OTHER

To evaluate the role of repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) in reducing pain, decreasing craving, alleviating withdrawal symptoms, lowering relapse rates, reducing impulsivity, and improving cognitive function in patients with Opioid Use Disorder

Opioid Group

Psychotherapy BEHAVIORAL

Using psychotherapy in opioid use disorder.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Age 18- 40
• Opioid use disorder

You may not qualify if:

• Individuals with mental disorders (such as primary psychosis, schizophrenia, mental retardation, and brain damage induced mental disorder),
• History of epilepsy
• History of cardiovascular complications.
• History of contraindications to TMS (e.g. metal implants in the head).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, Egypt

Location

Related Publications (5)

• Yang S, Chang MC. Effect of Repetitive Transcranial Magnetic Stimulation on Pain Management: A Systematic Narrative Review. Front Neurol. 2020 Feb 18;11:114. doi: 10.3389/fneur.2020.00114. eCollection 2020.

  PMID: 32132973 BACKGROUND

• Addolorato G, Antonelli M, Cocciolillo F, Vassallo GA, Tarli C, Sestito L, Mirijello A, Ferrulli A, Pizzuto DA, Camardese G, Miceli A, Diana M, Giordano A, Gasbarrini A, Di Giuda D. Deep Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex in Alcohol Use Disorder Patients: Effects on Dopamine Transporter Availability and Alcohol Intake. Eur Neuropsychopharmacol. 2017 May;27(5):450-461. doi: 10.1016/j.euroneuro.2017.03.008. Epub 2017 Apr 6.

  PMID: 28390775 BACKGROUND

• Liu X, Zhao X, Liu T, Liu Q, Tang L, Zhang H, Luo W, Daskalakis ZJ, Yuan TF. The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder. EBioMedicine. 2020 Jun;56:102809. doi: 10.1016/j.ebiom.2020.102809. Epub 2020 Jun 5.

  PMID: 32512513 BACKGROUND

• Tsai TY, Wang TY, Liu YC, Lee PW, Chang WH, Lu TH, Tseng HH, Lee SY, Chang YH, Yang Y, Chen PS, Chen KC, Yang YK, Lu RB. Add-on repetitive transcranial magnetic stimulation in patients with opioid use disorder undergoing methadone maintenance therapy. Am J Drug Alcohol Abuse. 2021 May 4;47(3):330-343. doi: 10.1080/00952990.2020.1849247. Epub 2021 Jan 10.

  PMID: 33426970 BACKGROUND

• Imperatore JP, McCalley DM, Borckardt JJ, Brady KT, Hanlon CA. Non-invasive brain stimulation as a tool to decrease chronic pain in current opiate users: A parametric evaluation of two promising cortical targets. Drug Alcohol Depend. 2021 Jan 1;218:108409. doi: 10.1016/j.drugalcdep.2020.108409. Epub 2020 Nov 23.

  PMID: 33250384 BACKGROUND

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 14, 2024
• Study Start: August 22, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-10

Locations

EG (1)