Substance use disorders Mental and Behavioural Disorders
Conditions
Interventions
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-par
Sponsors
Dubai Health Authority
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Arab Emirates
Contacts
Public ContactSamer El Hayek
Outcome results
None listed