Behavioural Intervention
Active TBS for Opioid Use Disorder
Centre for Addiction and Mental Health, Toronto, Canada
Targeting 2 different conditionsActive TBS +1 moreN/ARecruitingLed by Daphne Voineskos, MD, PhDResearch Sponsored by Centre for Addiction and Mental HealthEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Opioid Dependence and MDD.
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upchange from baseline, to end of tbs treatment course (4 weeks), and at 1 month follow up
Awards & highlights
Study Summary
This trial will compare the effects of a real vs. fake brain stimulation treatment on patients with both opioid addiction and depression who are experiencing suicidal thoughts.
Eligible Conditions
- Opioid Use Disorder
- Depression
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with Opioid Dependence and Major Depressive Disorder (MDD) through a specific kind of interview called MINI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline, to end of tbs treatment course (4 weeks), and at 1 month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline, to end of tbs treatment course (4 weeks), and at 1 month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Scale for Suicidal Ideation Remission
Secondary outcome measures
Mental Depression
Change in Columbia - Suicide Severity Rating Scale Change
Change in Scale for Suicidal Ideation Change
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TBSExperimental Treatment1 Intervention
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).
Group II: Sham TBSPlacebo Group1 Intervention
Daily, 4-week, 5-days per week treatment sessions. The sham coil will generate auditory and somatosensory (vibratory) stimuli identical to the active stimulation.
Find a site
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
340 Previous Clinical Trials
81,085 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
161 Previous Clinical Trials
26,805 Total Patients Enrolled
Daphne Voineskos, MD, PhDPrincipal Investigator
Clinician Scientist, PsychiatristFrequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being enrolled in the research project?
"Affirmative. Clinicaltrials.gov records demonstrate that the trial, first posted on March 1st 2022, is actively recruiting patients with 20 volunteers needed from one medical facility."
Answered by AI
Are new participants being welcomed into this medical experiment?
"Affirmative. According to the clinicaltrials.gov database, this trial is still recruiting patients and has been since March 1st 2022 when it was initially listed. As of October 17th 2021, 20 volunteers are needed from a single study site."
Answered by AI