Substance Use DisordersNCT04691167
the Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
A study testing repetitive trans magnetic stimulation in people with Substance Use Disorders, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- repetitive trans magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
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.
- Conditions
- Substance Use Disorders
- Being tested
- repetitive trans magnetic stimulation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive trans magnetic stimulationDevice
Also called r-TMS
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.
| Study group | Role | What they receive |
|---|---|---|
| group 1, Active intervention group | Active comparator | Not described Receives: Device: repetitive trans magnetic stimulation |
| group 2, sham controlled group | Sham comparator | Not described Receives: Device: repetitive trans magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
heroin craving
using the heroin craving questionnaire, a higher score indicates a worse outcome
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study startJun 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ahmed Saad, Ain Shams University
- Investigators
- amany haroun, BCH, MD, Study chair, professor at ain shams university, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691167
- Sponsor's protocol ID
- r-TMS
- Status last verified
- Apr 2022
- First submitted
- 21 Oct 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
- ClinicalTrials.gov ID
- NCT04691167
- Acronym / sponsor ID
- r-TMS
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1, Active intervention group | Active comparator | Device: repetitive trans magnetic stimulation |
| group 2, sham controlled group | Sham comparator | Device: repetitive trans magnetic stimulation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive trans magnetic stimulationAlso: r-TMSRepetitive 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. | Device | group 1, Active intervention group, group 2, sham controlled group |
Primary outcome
craving severity
Time frame: 6 weeks
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
Time frame: 6 weeks
using the heroin craving questionnaire, a higher score indicates a worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
amany haroun, BCH, MD study chair
professor at ain shams university, faculty of medicine
Questions about this trial
What is this clinical trial studying?
A study testing repetitive trans magnetic stimulation in people with Substance Use Disorders, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha Ahmed saad, bch,MS (01227666923 ext. 002, nohaahmedsaad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
craving severity (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.