Role of High Frequency RTMS in Management of Opioid Use Disorder

November 13, 2024 updated by: Sawy Alaa Sawy, Assiut University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of Medicine, Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Opioid Group
Participants diagnosed with Opioid use disorder
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
Sham Comparator: Control Group
Participants who do not have Opioid use disoder
Behavioral: Psychotherapy
Using psychotherapy in opioid use disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of rTMS in managing opioid use disorders using multiple scales
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) in improving cognition using Montreal Cognitive Assessment (MoCA) scale.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTMS in opioid patients in Egy
  • assiut university (Other Identifier: assiut university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Because I have not take the permission from supper visors yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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