rTMS for Suicidality in Opioid Use Disorder

NCT04785456 | Completed

• 1 other identifier: 131/2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Opioid-use Disorder

Keywords

Suicidality; rTMS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Scale for Suicidal Ideation Change

  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

  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

  Baseline, after TBS treatment course (4 weeks), and at 1 month follow up

• Visual Analogue Scale for Opioid Cravings Change

  Baseline, after TBS treatment course (4 weeks), and at 1 month follow up

• Timeline Followback Change

  Baseline, after TBS treatment course (4 weeks), and at 1 month follow up

Study Arms (2)

Active TBS

EXPERIMENTAL

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

Sham TBS

SHAM COMPARATOR

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

Interventions

Active TBS DEVICE

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

Active TBS

Sham TBS DEVICE

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

Sham TBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (1)

• Tang VM, Le Foll B, Daskalakis ZJ, Wang AL, Buckley L, Blumberger DM, Voineskos D. Repetitive transcranial magnetic stimulation for the treatment of suicidality in opioid use disorder: a pilot feasibility randomized controlled trial. Eur Psychiatry. 2025 Mar 5;68(1):e63. doi: 10.1192/j.eurpsy.2025.28.

  PMID: 40040511 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Opioid-Related Disorders; Suicidal Ideation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Daphne Voineskos, MD, PhD

  Clinician Scientist, Psychiatrist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: March 8, 2021
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

CA (1)