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Completed

NCT Number: NCT04785456

rTMS for Suicidality in Opioid Use Disorder

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Chemically-Induced Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder Self-Injurious Behavior Substance-Related Disorders Suicidal Ideation Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active TBS

Device

MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)

Sham TBS

Device

MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2021
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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