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NCT Number: NCT06585709

OUD (Opioid Use Disorder) Target Trial

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Gregory Sahlem

CONTACT

[email protected]

984-340-0761

Gregory Sahlem, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older; all genders included.
  • Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing).
  • 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.
  • Starting buprenorphine and planning on opioid abstinence

Exclusion criteria

  • Pregnant, breast-feeding, or planning on getting pregnant.
  • Alcohol or sedative/hypnotic use disorders (seizure risk).
  • History of/or current psychotic disorder (e.g. schizophrenia).
  • Current or lifetime bipolar disorder.
  • Unstable Axis-I condition requiring starting a new medication.
  • Active suicidal ideation / suicide attempt within 90 days.
  • History of/or current dementia or other cognitive impairment.
  • Contraindications to receiving rTMS or undergoing MRI (implanted ferromagnetic metal, history of or high risk of seizure, implanted device).
  • Unstable general medical conditions.

Treatment and study plan

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.

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.

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 <mean voxels in the ventral striatum activate

Primary outcomes

  1. Number of participants with Relapse Free survival

    Time frame: Up to 12 weeks

    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.

Secondary outcomes

  1. Weeks of opioid abstinance

    Time frame: 12-weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Sahlem

CONTACT

[email protected]

(984) 340-0761

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Stanford University

Registry information

Official study title

The Development and Validation of Neural Targets in Opioid Use Disorder

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2024
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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