Clinical trial NCT04785456: rTMS for Suicidality in Opioid Use Disorder
Official title: Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Opioid-use Disorder
Keywords: Suicidality
rTMS
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2021-03-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) is used therapeutically in major depressive disorder resistant to standard treatments, and recently also shown to be effective in reducing suicidality with a bilateral approach. Recently, a new form of rTMS has been developed called theta burst stimulation (TBS) which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rTMS. The investigators propose to conduct a randomized controlled clinical trial of a daily, 20 session course of bilateral TBS versus sham stimulation in the treatment of suicidality in patients with OUD and MDD. The investigators will explore whether TBS can have other clinical effects on decreasing symptoms of MDD, craving for opioids, and rates of relapse to opioid use. The investigators will also examine whether rTMS can engage GABA mediated inhibition using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG) will be assessed before and after intervention. Clinical outcomes measured before, during, at end of treatment, and 4-weeks post treatment.

Eligibility criteria: Inclusion Criteria:

1. Capable of providing informed consent and research procedures according to the brain stimulation attending psychiatrist
2. Between the ages of 18-60 years
3. Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Opioid Dependence and MDD.
4. 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.
5. Baseline score of \>/=4 on the scale for suicidal ideation (SSI).

Exclusion Criteria:

1. Currently pregnant or intending to be pregnant during the duration of the study
2. Bipolar disorder, any psychotic disorder or current psychotic symptoms
3. Previous rTMS treatment
4. Known active seizure disorder, significant head injury with an imaging verified lesion
5. Unstable medical illness
6. Presence of cardiac pacemaker, intracranial implant, or metal in the cranium
7. Participants taking \> 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Change in Scale for Suicidal Ideation Change
timeFrame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
measure: Change in Columbia - Suicide Severity Rating Scale Change
timeFrame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
measure: 17-item Hamilton Rating Scale for Depression (HRSD-17) Change
timeFrame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
measure: Visual Analogue Scale for Opioid Cravings Change
timeFrame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
measure: Timeline Followback Change
timeFrame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Clinician Scientist, Psychiatrist
name: Daphne Voineskos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: