OUD (Opioid Use Disorder) Target Trial

Summary

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:

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.

Conditions

• Opioid Use Disorder

Interventions

DEVICE

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.

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.

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Gregory Sahlem · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-31

Primary Completion

2026-10-31

Completion

2026-10-31

FDA Device

Yes

Countries

• United States

Study Locations