rTMS for Suicidality in Opioid Use Disorder

Sponsor

Centre for Addiction and Mental Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT04785456

Collaborator

The Physicians' Services Incorporated Foundation (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Opioid-use Disorder	Device: Active TBS Device: Sham TBS	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Change in Scale for Suicidal Ideation Remission [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.

Secondary Outcome Measures

Change in Scale for Suicidal Ideation Change [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 in Columbia - Suicide Severity Rating Scale Change [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
17-item Hamilton Rating Scale for Depression (HRSD-17) Change [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
Visual Analogue Scale for Opioid Cravings Change [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.
Timeline Followback Change [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.