NCT04785456Completed
rTMS for Suicidality in Opioid Use Disorder
Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders
Source: ClinicalTrials.gov · Last updated 5 Mar 2024
Brief summary (registry, in English)
This trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depressive Disorder (MDD) experiencing suicidality.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 12 Feb 2021
- Start date
- 1 Mar 2022
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Depression
- NCT number
- NCT04785456
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 1 Mar 2022 to the primary completion date, 1 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous rTMS treatment
- Participants taking \> 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.
Other illness
- Bipolar disorder, any psychotic disorder or current psychotic symptoms
- Known active seizure disorder, significant head injury with an imaging verified lesion
- Unstable medical illness
- Presence of cardiac pacemaker, intracranial implant, or metal in the cranium
Other
- Currently pregnant or intending to be pregnant during the duration of the study
Who the study is looking for
- Capable of providing informed consent and research procedures according to the brain stimulation attending psychiatrist
- Between the ages of 18-60 years
- Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Opioid Dependence and MDD.
- On a stable treatment regimen without any change in opioid agonist or antidepressant medications or dosages in the last 30 days. Participants will be asked not to change their medication regimen for the duration of the study.
- Baseline score of \>/=4 on the scale for suicidal ideation (SSI).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.