CompletedNot Applicable

rTMS for Suicidality in Opioid Use Disorder

Canada10 participantsStarted 2022-03-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. Currently pregnant or intending to be pregnant during the duration of the study
✕. Bipolar disorder, any psychotic disorder or current psychotic symptoms
✕. Previous rTMS treatment
✕. 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
✕. Participants taking \> 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.

What they're measuring

Change in Scale for Suicidal Ideation Remission

Timeframe: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up

Trial details

NCT IDNCT04785456

SponsorCentre for Addiction and Mental Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

View on ClinicalTrials.gov More Major Depressive Disorder trials