rTMS for Suicidality in Opioid Use Disorder

Major Depressive Disorder Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785456
• Other study ID #: 131/2020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders
• Suicidal Ideation

Intervention

Device:
• Active TBS
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
• Sham TBS
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Scale for Suicidal Ideation Remission	A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.	Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Secondary	Change in Scale for Suicidal Ideation Change	A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.	Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Secondary	Change in Columbia - Suicide Severity Rating Scale Change	An interviewer-rated suicide risk assessment tool. Min value = 0, Max value = N/A. Higher score = worse outcome	Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Secondary	17-item Hamilton Rating Scale for Depression (HRSD-17) Change	A rating scale for measuring severity of depressive symptoms. Min value = 0 Max value = 52. Higher score = worse outcome	Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Secondary	Visual Analogue Scale for Opioid Cravings Change	A rating scale for subjective cravings to use opioids. Min value = 0 Max value = 100. Higher score = worse outcome.	Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Secondary	Timeline Followback Change	Self-reported substance use over a designated period of time. Min value = 0 Max value = N/A. Higher score = worse outcome.	Baseline, after TBS treatment course (4 weeks), and at 1 month follow up