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rTMS for Suicidality in Opioid Use Disorder

Primary Purpose

Major Depressive Disorder, Opioid-use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active TBS
Sham TBS
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Suicidality, rTMS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active TBS

Sham TBS

Arm Description

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).

Daily, 4-week, 5-days per week treatment sessions. The sham coil will generate auditory and somatosensory (vibratory) stimuli identical to the active stimulation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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
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
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.
Timeline Followback Change
Self-reported substance use over a designated period of time. Min value = 0 Max value = N/A. Higher score = worse outcome.

Full Information

First Posted
February 12, 2021
Last Updated
October 17, 2022
Sponsor
Centre for Addiction and Mental Health
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04785456
Brief Title
rTMS for Suicidality in Opioid Use Disorder
Official Title
Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Opioid-use Disorder
Keywords
Suicidality, rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TBS
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham TBS
Arm Type
Sham Comparator
Arm Description
Daily, 4-week, 5-days per week treatment sessions. The sham coil will generate auditory and somatosensory (vibratory) stimuli identical to the active stimulation.
Intervention Type
Device
Intervention Name(s)
Active TBS
Intervention Description
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
Intervention Type
Device
Intervention Name(s)
Sham TBS
Intervention Description
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
Primary Outcome Measure Information:
Title
Change in Scale for Suicidal Ideation Remission
Description
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
Time Frame
Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Secondary Outcome Measure Information:
Title
Change in Scale for Suicidal Ideation Change
Description
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
Time Frame
Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Title
Change in Columbia - Suicide Severity Rating Scale Change
Description
An interviewer-rated suicide risk assessment tool. Min value = 0, Max value = N/A. Higher score = worse outcome
Time Frame
Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Title
17-item Hamilton Rating Scale for Depression (HRSD-17) Change
Description
A rating scale for measuring severity of depressive symptoms. Min value = 0 Max value = 52. Higher score = worse outcome
Time Frame
Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Title
Visual Analogue Scale for Opioid Cravings Change
Description
A rating scale for subjective cravings to use opioids. Min value = 0 Max value = 100. Higher score = worse outcome.
Time Frame
Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Title
Timeline Followback Change
Description
Self-reported substance use over a designated period of time. Min value = 0 Max value = N/A. Higher score = worse outcome.
Time Frame
Baseline, after TBS treatment course (4 weeks), and at 1 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mawahib Semeralul
Phone
4165358501
Ext
3021
Email
mawahib.semeralul@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne Voineskos, MD, PhD
Phone
4165358501
Ext
30176
Email
daphne.voineskos@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne Voineskos, MD, PhD
Organizational Affiliation
Clinician Scientist, Psychiatrist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mawahib Semeralul
Phone
4165358501
First Name & Middle Initial & Last Name & Degree
Victor Tang, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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rTMS for Suicidality in Opioid Use Disorder

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