What this study is
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.
What's being tested
- Active repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention · 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)
Intervention · 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
Intervention · 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
Intervention · 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
Study details
- Official title
- The Development and Validation of Neural Targets in Opioid Use Disorder
- Sponsor
- Duke University
- Conditions
- Opioid Use Disorder
- Enrolling
- 80 people
- Starts
- 2024-12-31
- Est. completion
- 2026-10-31
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openDuke University
Durham, North Carolina, United States
- Gregory Sahlem · Contact984-340-0761quitopioids@duke.edu
- Gregory Sahlem, MD · Principal investigator
Recruiting
Study team
Sponsor
Duke University
Study ID Pro00116151
Principal investigator
Gregory Sahlem
Duke University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.