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| Name | Class |
|---|---|
| Stanford University | OTHER |
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In this research study the investigators will work with 80-participants with opioid use disorder who are starting treatment with the medication buprenorphine and are trying to quit using opioids.
The investigators are trying to learn two things:
In order to complete the study the investigators will ask participants to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Experimental | 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. |
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| Sham rTMS | Sham Comparator | Double-blind sham-rTMS in an identical fashion to the active-rTMS condition will be delivered. |
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| High Ventral Striatal Reactivity | Other | 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 |
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| Low Ventral Striatal Reactivity | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active repetitive Transcranial Magnetic Stimulation (rTMS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Relapse Free survival | The number of participants who have not met relapse criteria in the 12-week follow-up phase. Relapse is defined as a) any opioid use in 4 consecutive weeks, or b) any opioid use on 7 consecutive days. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weeks of opioid abstinance | Number of weeks in the 12-week follow-up period that the participant is abstinent from opioids based on self-report and a negative urine drug test | 12-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory Sahlem | Contact | (984) 340-0761 | quitopioids@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gregory Sahlem | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Sham repetitive Transcranial Magnetic Stimulation (rTMS) | Device | 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. |
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| High Ventral Striatal Reactivity | Diagnostic Test | 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 | Diagnostic Test | We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define low ventral striatal reactivity as having \ |
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