Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206487514449 Date of Registration: 10/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The role of repetitive trans cranial magnetic stimulation in craving reduction among a sample of opioid use disorder patients.
Official scientific title The role of repetitive trans cranial magnetic stimulation in craving reduction among a sample of opioid use disorder patients.
Brief summary describing the background and objectives of the trial Craving is a core feature of substance use disorders, as evidenced by its recent addition to the diagnostic criteria for these disorders in the Diagnostic and Statistical Manual of Mental Disorders. 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2022
Actual trial start date
Anticipated date of last follow up 01/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group repetitive trans cranial magnetic stimulation The repetitive trans cranial magnetic stimulation treatment will be delivered for 3 sessions /week during six weeks, for a total of 18 treatment sessions, each session lasts for 13 minutes. 6 weeks Group 1 will receive real r-TMS 26
Control Group sham repetitive trans cranial magnetic stimulation The repetitive trans cranial magnetic stimulation treatment will be delivered for 3 sessions /week during six weeks, for a total of 18 treatment sessions, each session lasts for 13 minutes. 6 weeks Group 2 who will receive Sham rTMS 26 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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) 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. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 45 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/01/2019 FMASU REC
Ethics Committee Address
Street address City Postal code Country
abbasia cairo 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction in craving levels after application if 18 r-TMS sessions 6 weeks, after 18 sessions
Secondary Outcome relapse reduction among the sample that received real r-TMS 6 weeks, after 18 sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university Okasha institute of psychiatry abasseya cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
noha ahmed saad ibrahim abu el naga street cairo 19515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams university psychiatric institute abbasia cairo 11765 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
hanan hany el rasas heliopolis cairo Egypt
amany haroon el rashid heliopolis cairo Egypt
yasser abd el razek 5h settlement cairo Egypt
mahmoud morsi 5th settlement cairo Egypt
lobna azzam new cairo cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noha ahmed nohaahmedsaad@gmail.com +20127666923 ibrahim abu el naga street, nasr city
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer of psychiatry at Ain Shams Univesity
Role Name Email Phone Street address
Public Enquiries Noha Ahmed nohaahmedsaad@gmail.com 00201227666923 nasrcity
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer of psychiatry
Role Name Email Phone Street address
Scientific Enquiries Noha Ahmed nohaahmedsaad@gmail.com 00201227666923 Nasrcity
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer of psychiatry Ain Shmas University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in the article will be shared after de-identification. Study Protocol 12 month after completion controlled access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information