Repetitive transcranial magnetic stimulation for the treatment of substance dependence
| ISRCTN | ISRCTN10128199 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10128199 |
| Secondary identifying numbers | DSREC-01/2021_12 |
- Submission date
- 26/09/2023
- Registration date
- 11/10/2023
- Last edited
- 18/04/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Addiction is a growing problem worldwide, including in the United Arab Emirates (UAE). According to the National Rehabilitation Center in Abu Dhabi, drug addiction costs the UAE a total of Dh 5.5 billion every year. Therefore, it is paramount that substance use disorders (SUDs) are addressed vigorously.
As individuals with SUDs typically have other mental health problems such as depression, having a treatment that can potentially target both disorders simultaneously would be of high benefit and cost-effective.
Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technique approved for the treatment of depression. Treatment with rTMS was also shown to reduce cravings in patients with SUDs.
This study aims to investigate the effectiveness of depression treatment using rTMS (as approved by the FDA) in reducing craving and consumption of illicit substances, and its effect on abstinence duration among patients with SUDs.
Who can participate?
Male patients aged 18-65 years meeting the criteria for psychoactive substance dependence, who are under the care of the Erada Center and who are admitted for detoxification and rehabilitation from November 2023 to November 2024.
What does the study involve?
Patients will receive rTMS treatment in two phases:
Phase 1: five times per week for 4 weeks (total 20 treatments)
Phase 2: two times as needed at 1 month, 3 months, and 6 months follow-up
What are the possible benefits and risks of participating?
Benefits include a decrease in cravings, maintenance of abstinence, and reduction in the severity of symptoms of depression, if present.
Risks are related to the side effects of rTMS (headache in 5-23% of cases and discomfort at the site of stimulation in 20-40% of cases).
The most serious side effect associated with rTMS is the accidental induction of a seizure.
Although accidental seizures occur at a frequency of <0.1%, there are factors that may increase the TMS risk of triggering a seizure such as family history of seizures, alcohol use, and previous neurological conditions. These are part of the exclusion criteria that will be used during the recruitment process. Furthermore, throughout the sessions, participants will be closely monitored by a team member for any side effects and managed accordingly.
Where is the study run from?
Erada Center for Treatment and Rehabilitation in Dubai (United Arab Emirates)
When is the study starting and how long is it expected to run for?
February 2021 to January 2026
Who is funding the study?
Erada Center for Treatment and Rehabilitation in Dubai (United Arab Emirates)
Who is the main contact?
Dr Samer El Hayek, s.elhayek@erada.ae
Contact information
Principal Investigator
Erada Center for Treatment and Rehabilitation in Dubai
Dubai
00000
United Arab Emirates
 ORCID ID |
0000-0002-2255-726X |
|---|---|
| Phone | +971 (0)553396446 |
| w.foad@erada.ae |
Scientific
Erada Center for Treatment and Rehabilitation in Dubai
Dubai
00000
United Arab Emirates
| ORCID ID |
0000-0002-7975-6104 |
|---|---|
| Phone | +971 (0)547821160 |
| s.elhayek@erada.ae |
Public
Erada Center for Treatment and Rehabilitation in Dubai
Dubai
00000
United Arab Emirates
| Phone | +971 (0)547821160 |
|---|---|
| s.elhayek@erada.ae |
Study information
| Study design | Interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Medical and other records |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Repetitive transcranial magnetic stimulation effect on craving and period of abstinence in patients with substance use disorders |
| Study acronym | rTMS-CASUD |
| Study hypothesis | This research aims, through a prospective longitudinal trial study, to investigate the effectiveness of depression treatment protocol of repetitive transcranial magnetic stimulation (rTMS) (as approved by the FDA) in reducing craving and consumption of illicit substances, and its effect on abstinence duration among patients with substance use disorders (SUDs). Does treatment of individuals with SUDs with rTMS using FDA-approved depression protocol to the left dorsolateral prefrontal cortex (DLPFC): 1. Reduce consumption of, and craving for, substances of use? 2. Prolong the abstinence period? |
| Ethics approval(s) | Approved 08/02/2021, Dubai Scientific Research Ethics Committee (Dubai Health Authority Headquarters - First Floor - Medical Education & Research Department - Medical Research Section; +971 (0)4 502 7518; DSREC@dha.gov.ae), ref: DSREC-01/2021_12 |
| Condition | Substance use disorders |
| Intervention | Participants will be randomized into one of two treatment groups: 1) active rTMS to the left dorsolateral prefrontal cortex and 2) sham rTMS to the left. Participants will be randomized by a third-party team member. The treating psychiatrist and the technician providing rTMS will be blinded to the randomization. The study will be conducted in two phases: During phase 1 (treatment initiation), participants will receive their assigned treatment five times weekly for 4 weeks (total of 20 treatments). During phase 2 (follow-up), participants will receive two treatments as needed at 1 month, 3 months and 6 months follow-up points. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Repetitive transcranial magnetic stimulation (rTMS) |
| Primary outcome measure | During phase 1 (treatment initiation), participants will receive their assigned treatment 5 times weekly for 4 weeks (total of 20 treatments). The outcomes will be: 1. Craving for the substances of use, measured using the Brief Substance Craving Scale (BSCS) total score at baseline and after every 5th session of TMS 2. Substance(s) of misuse consumption as evidenced by confirmed lab results of UDS at baseline, randomly twice per week during inpatient admission, and on every outpatient follow-up visit after discharge During phase 2 (follow-up), participants will receive 2 treatments as needed at 1 month, 3 months and 6 months follow-up points. The outcomes will be: 1. Craving for the substances of use, measured using the Brief Substance Craving Scale (BSCS) total score at 1 month, 3 months and 6 months follow-up points 2. Substance(s) of misuse consumption as evidenced by confirmed lab results of UDS on every outpatient follow-up visit after discharge |
| Secondary outcome measures | During phase 1 (treatment initiation), participants will receive their assigned treatment 5 times weekly for 4 weeks (total of 20 treatments). The outcomes will be: 1. Time to relapse measured using the number of days with negative UDS, until positive UDS results 2. Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) at baseline and after every 10th session of TMS During phase 2 (follow-up), participants will receive 2 treatments as needed at 1 month, 3 months and 6 months follow-up points. The outcomes will be: 2. Time to relapse measured using the number of days with negative UDS, until positive UDS results 2. Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) at 1 month, 3 months, and 6 months follow-up points |
| Overall study start date | 08/02/2021 |
| Overall study end date | 01/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Male |
| Target number of participants | 112 |
| Participant inclusion criteria | Current inclusion criteria as of 18/04/2024: 1. Male patients aged 18-65 years 2. Meeting criteria for current SUD (moderate to severe) according to the International Classification of Diseases, Tenth Revision criteria (ICD-10) 3. Under the care of Erada Center and admitted for detoxification and rehabilitation and/or following at the outpatient clinic during the period of the trial 4. Abstinence from any substance of use for at least seven days as indicated by a negative urine drug screen (UDS) prior to initiation of sham or active rTMS Previous inclusion criteria: 1. Male patients aged 18-65 years 2. Meeting criteria for psychoactive substance dependence according to the ICD-10 criteria 3. Under the care of Erada center and admitted for detoxification and rehabilitation from October 2023 to October 2024 4. Positive drug screen confirmed through urine analysis 5. HADS and BSCS will be routinely applied to all inpatients As per the Neuromodulation Unit Criteria for rTMS treatment; patients need to meet the following criteria: 1. Current diagnosis of SUD (moderate to severe), based on the ICD-10 criteria 2. Abstinence from any substance of use for at least seven days as indicated by a negative urine drug screen |
| Participant exclusion criteria | As per the Neuromodulation Unit existing criteria and as per the findings at the time of assessment for rTMS: 1. Current ICD-10 diagnoses of alcohol use disorder or any general mental health disorder (schizophrenia, major depressive disorder, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, etc). 2. Use in the past 2 weeks of any medication with known pro-convulsant action; or current regular use of any of the following medications: benzodiazepines, antipsychotic medications and tricyclic antidepressants (in therapeutic doses), anti-epileptics, or mood stabilizers. 3. History of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for >5 minutes and retrograde amnesia for >30 minutes. 4. Any personal or family history (1st-degree relatives) of seizures other than febrile childhood seizures. 5. Ferromagnetic object in the body rendering rTMS unsafe such as cardiac pacemaker or defibrillator, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, or cochlear implants. 6. Patients started on, or imminently planned to start on Buprenorphine for Medication Assisted Treatment. |
| Recruitment start date | 15/01/2024 |
| Recruitment end date | 01/06/2025 |
Locations
Countries of recruitment
- United Arab Emirates
Study participating centre
Dubai
00000
United Arab Emirates
Sponsor information
Government
Sheikh Ahmed Square, Al Jaddaf
Dubai
00000
United Arab Emirates
| Phone | +971 (0)42198888 |
|---|---|
| info@dha.gov.ae | |
| Website | https://www.dha.gov.ae/en/pages/dhahome.aspx |
"ROR" |
https://ror.org/01dcrt245 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Samer El Hayek (s.elhayek@erada.ae or samer.elhayek@gmail.com). The data will include the cleaned set of collected variables and scores on outcomes; it will be available up to 2 years from the publication of the study unless later on stated otherwise. Consent will be taken from all patients prior to enrolment and will include data sharing. All data will be anonymized. |
Editorial Notes
18/04/2024: The inclusion criteria were updated.
14/02/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 01/11/2024 to 01/06/2025.
2. The overall study end date was changed from 01/12/2024 to 01/01/2026.
3. The intention to publish date was changed from 01/09/2025 to 01/07/2026.
28/11/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/11/2023 to 15/01/2024.
2. The participant level data sharing statement was added.
10/10/2023: Study's existence confirmed by the Dubai Scientific Research Ethics Committee.
