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Enrolling by invitation NCT06689072

Role of High Frequency RTMS in Management of Opioid Use Disorder

No phase Interventional Addiction Opioid RTMS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rTMS, Psychotherapy.
Who it may be relevant to
Registry conditions: Addiction, Opioid, RTMS. Basic parameters: 18 years — 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Role of High Frequency Repetitive Transcranial Magnetic Stimulation in Management of Patients with Opioid Use Disorder in Upper Egypt

Overview

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.

Detailed description

Addiction is a complex, chronic brain condition influenced by genes and the environment that is characterized by substance use or compulsive actions that continue despite harmful consequences. For a long time, addiction meant an uncontrollable habit of using alcohol or other drugs as opioid. More recently, the concept of addiction has expanded to include behaviors, as well as substances, and even ordinary and necessary activities, such as exercise and eating.

Speaking of opioid addiction, Opioid addiction is a long-lasting (chronic) disease that can cause major health, social, and economic problems. Opioids are a class of drugs that act in the nervous system to produce feelings of pleasure and pain relief. Some opioids are legally prescribed by healthcare providers to manage severe and chronic pain. Commonly prescribed opioids include oxycodone, fentanyl, buprenorphine, methadone, oxymorphone, hydrocodone, codeine, and morphine. Some other opioids, such as heroin, are illegal drugs of abuse.

Opioid addiction is characterized by a powerful, compulsive urge to use opioid drugs, even when they are no longer required medically. Opioids have a high potential for causing addiction in some people, even when the medications are prescribed appropriately and taken as directed. Many prescription opioids are misused or diverted to others. Individuals who become addicted may prioritize getting and using these drugs over other activities in their lives, often negatively impacting their professional and personal relationships. It is unknown why some people are more likely to become addicted than others.

Interventions

  • Other rTMS
    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
  • Behavioral Psychotherapy
    Using psychotherapy in opioid use disorder.

Primary outcome measures

  • Role of rTMS in managing opioid use disorders using multiple scales [Time frame: 2 years]
  • RTMS in managing opioid use disorder in Upper Egypt [Time frame: 2 years]
  • RTMS in managing opioid use disorder in Upper Egypt [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Male
  • Age 18- 40
  • Opioid use disorder

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine, Assiut University — Asyut

Publications

  • 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
  • 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):4 PMID 28390775
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06689072 · RTMS in opioid patients in Egy · Assiut University

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗