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OUD (Opioid Use Disorder) Target Trial

Duke University logo

Duke University

Status

Enrolling

Conditions

Opioid Use Disorder

Treatments

Diagnostic Test: High Ventral Striatal Reactivity
Diagnostic Test: Low Ventral Striatal Reactivity
Device: Active repetitive Transcranial Magnetic Stimulation (rTMS)
Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT06585709
Pro00116151

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 4 patient groups

Active rTMS
Experimental group
Description:
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.
Treatment:
Device: Active repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS
Sham Comparator group
Description:
Double-blind sham-rTMS in an identical fashion to the active-rTMS condition will be delivered.
Treatment:
Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS)
High Ventral Striatal Reactivity
Other group
Description:
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
Treatment:
Diagnostic Test: High Ventral Striatal Reactivity
Low Ventral Striatal Reactivity
Other group
Description:
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
Treatment:
Diagnostic Test: Low Ventral Striatal Reactivity

Trial contacts and locations

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Central trial contact

Gregory Sahlem

Data sourced from clinicaltrials.gov

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