Recruiting

Buprenorphine & rTMS

Sponsor:

Duke University

Code:

NCT06585709

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active repetitive Transcranial Magnetic Stimulation (rTMS)

Sham repetitive Transcranial Magnetic Stimulation (rTMS)

High Ventral Striatal Reactivity

Low Ventral Striatal Reactivity

Study Details

Brief 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

Study ID

NCT06585709

Start date

Dec 31, 2024

Status verified date

Jan, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 or older; all genders included.
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:

1. Pregnant, breast-feeding, or planning on getting pregnant.
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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: Sham rTMS

Double-blind sham-rTMS in an identical fashion to the active-rTMS condition will be delivered.

other: 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

other: 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

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

Primary outcome measure

  • Number of participants with Relapse Free survival [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Gregory Sahlem

(984) 340-0761quitopioids@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Gregory Sahlem

984-340-0761quitopioids@duke.edu

Principal Investigator:

Gregory Sahlem, MD

More Information

Sponsor

Duke University

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-01-09.