OUD (Opioid Use Disorder) Target Trial

NCT06585709 | Recruiting DMC FDA Device

• 1 other identifier: Pro00116151
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

• 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Weeks of opioid abstinance

  12-weeks

Study Arms (4)

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.

Device: Active repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS

SHAM COMPARATOR

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

Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS)

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

Diagnostic Test: High Ventral Striatal Reactivity

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

Diagnostic Test: Low Ventral Striatal Reactivity

Interventions

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.

Active rTMS

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.

Sham rTMS

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

High Ventral Striatal Reactivity

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

Low Ventral Striatal Reactivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Stanford University: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Gregory Sahlem

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Sahlem

CONTACT

(984) 340-0761; quitopioids@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)