the Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
The Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
1 other identifier
interventional
52
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
December 31, 2020
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedApril 14, 2022
April 1, 2022
2 months
October 21, 2020
April 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
group 1, Active intervention group
ACTIVE COMPARATORgroup 2, sham controlled group
SHAM COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
amany haroun, BCH, MD
professor at ain shams university, faculty of medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single blind sham-controlled randomized clinical trial
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer of Neuropsychiatry
Study Record Dates
First Submitted
October 21, 2020
First Posted
December 31, 2020
Study Start
June 1, 2022
Primary Completion
August 1, 2022
Study Completion
October 1, 2022
Last Updated
April 14, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share