Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-12-31
2026-10-31
Brief Summary
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The investigators are trying to learn two things:
1. Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine?
2. Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation (rTMS) help people quit using opioids more than a sham (placebo) version of rTMS?
In order to complete the study the investigators will ask participants to:
* Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later.
* Undergo study-treatment with 30-sessions of either real or placebo rTMS in as little as 1-week (10-sessions-per-day for five days) or as long as over 6-weeks.
* Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active rTMS
A total of 30-sessions of standard iTBS (1800 pulses) will be delivered. rTMS-sessions will be ideally administered over 1-week (10-sessions-per-day, 50-minutes inter-session-interval, 5-days), but there will be flexibility in the delivery paradigm so long as participants complete all sessions of rTMS within 6 weeks and come in at least twice per week.
Active repetitive Transcranial Magnetic Stimulation (rTMS)
Active rTMS will be delivered with a MagVenture MagPro X100 rTMS device with a Cool-B65-AP coil. rTMS will be applied to a personalized treatment target within the Left-Dorsolateral Prefrontal Cortex using a Localite Neuronavigation device.
Sham rTMS
Double-blind sham-rTMS in an identical fashion to the active-rTMS condition will be delivered.
Sham repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS in an identical fashion to the active-rTMS condition will be delivered via the built-in e-sham system in the MagVenture device.
High Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define high ventral striatal reactivity as having \>mean voxels in the ventral striatum activate
High Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define high ventral striatal reactivity as having \>mean voxels in the ventral striatum activate
Low Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define low ventral striatal reactivity as having \< mean voxels in the ventral striatum activate
Low Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define low ventral striatal reactivity as having \<mean voxels in the ventral striatum activate
Interventions
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Active repetitive Transcranial Magnetic Stimulation (rTMS)
Active rTMS will be delivered with a MagVenture MagPro X100 rTMS device with a Cool-B65-AP coil. rTMS will be applied to a personalized treatment target within the Left-Dorsolateral Prefrontal Cortex using a Localite Neuronavigation device.
Sham repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS in an identical fashion to the active-rTMS condition will be delivered via the built-in e-sham system in the MagVenture device.
High Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define high ventral striatal reactivity as having \>mean voxels in the ventral striatum activate
Low Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define low ventral striatal reactivity as having \<mean voxels in the ventral striatum activate
Eligibility Criteria
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Inclusion Criteria
2. Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing).
3. Meet DSM-5 criteria for moderate or severe OUD. Individuals may also meet criteria for another substance use disorder (with the exception of alcohol or sedative/hypnotic); but must identify opioids as their primary substance.
4. Starting buprenorphine and planning on opioid abstinence
Exclusion Criteria
2. Alcohol or sedative/hypnotic use disorders (seizure risk).
3. History of/or current psychotic disorder (e.g. schizophrenia).
4. Current or lifetime bipolar disorder.
5. Unstable Axis-I condition requiring starting a new medication.
6. Active suicidal ideation / suicide attempt within 90 days.
7. History of/or current dementia or other cognitive impairment.
8. Contraindications to receiving rTMS or undergoing MRI (implanted ferromagnetic metal, history of or high risk of seizure, implanted device).
9. Unstable general medical conditions.
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Gregory Sahlem
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00116151
Identifier Type: -
Identifier Source: org_study_id
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