Back to resultsthe Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
Primary Purpose
Substance Use Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repetitive trans magnetic stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Substance Use Disorders
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
group 1, Active intervention group
group 2, sham controlled group
Arm Description
Outcomes
Primary Outcome Measures
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
heroin craving
using the heroin craving questionnaire, a higher score indicates a worse outcome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04691167
Brief Title
the Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
Official Title
The Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single blind sham-controlled randomized clinical trial
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1, Active intervention group
Arm Type
Active Comparator
Arm Title
group 2, sham controlled group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
repetitive trans magnetic stimulation
Other Intervention Name(s)
r-TMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
craving severity
Description
measure severity of drug craving using craving severity scale, the scale is called brief substance craving scale. a higher outcome is a worse result
Time Frame
6 weeks
Title
heroin craving
Description
using the heroin craving questionnaire, a higher score indicates a worse outcome
Time Frame
6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noha Ahmed saad, bch,MS
Phone
01227666923
Ext
002
Email
nohaahmedsaad@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amany haroun, BCH, MD
Organizational Affiliation
professor at ain shams university, faculty of medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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the Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
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