Repetitive transcranial magnetic stimulation for the treatment of substance dependence

Phase 3

• Conditions: Substance use disorders; Mental and Behavioural Disorders

• Registration Number: ISRCTN10128199
• Lead Sponsor: Dubai Health Authority

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-11
• Last Update Posted: 29 April 2024
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 112

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified