rTMS for Suicidality in Opioid Use Disorder

March 1, 2024 updated by: Centre for Addiction and Mental Health

Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active TBS

Daily, 4-week, 5-days per week treatment sessions, each consisting of:

First, intermittent TBS (iTBS) over the L-DLPFC: triplet 50 Hz bursts, repeated at 5 Hz, 2 s on and 8 s off, (600 pulses per session, total duration of 3 min 9 s), then continuous TBS (cTBS) over the R-DLPFC as 40 s uninterrupted bursts (600 pulses). Intensity at 120% resting motor threshold (RMT).
Device: Active TBS
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
Sham Comparator: Sham TBS
Daily, 4-week, 5-days per week treatment sessions. The sham coil will generate auditory and somatosensory (vibratory) stimuli identical to the active stimulation.
Device: Sham TBS
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Scale for Suicidal Ideation Remission
Time Frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Scale for Suicidal Ideation Change
Time Frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
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
Change in Columbia - Suicide Severity Rating Scale Change
Time Frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
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
17-item Hamilton Rating Scale for Depression (HRSD-17) Change
Time Frame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
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
Visual Analogue Scale for Opioid Cravings Change
Time Frame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
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
Timeline Followback Change
Time Frame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Daphne Voineskos, MD, PhD, Clinician Scientist, Psychiatrist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on Active TBS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe