Opioid Use DisorderNCT06585709
OUD (Opioid Use Disorder) Target Trial
A study testing Active repetitive Transcranial Magnetic Stimulation (rTMS), High Ventral Striatal Reactivity and Low Ventral Striatal Reactivity in people with Opioid Use Disorder, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Active repetitive Transcranial Magnetic Stimulation (rTMS), High Ventral Striatal Reactivity and Low Ventral Striatal Reactivity
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
Gregory Sahlem, 984-340-0761, quitopioids@duke.edu
Gregory Sahlem, MD
About this study
Official title: The Development and Validation of Neural Targets in Opioid Use Disorder
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:
Read more
- Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine?
- 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
- Being tested
- Active repetitive Transcranial Magnetic Stimulation (rTMS), Sham repetitive Transcranial Magnetic Stimulation (rTMS), High Ventral Striatal Reactivity, Low Ventral Striatal Reactivity
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ReactivityDiagnostic 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 ReactivityDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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 Receives: Diagnostic Test: Low Ventral Striatal Reactivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Secondary outcomes (1)
Weeks of opioid abstinance
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
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start31 Dec 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Gregory Sahlem, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585709
- Sponsor's protocol ID
- Pro00116151
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Validation of Neural Targets in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06585709
- Acronym / sponsor ID
- Pro00116151
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Active repetitive Transcranial Magnetic Stimulation (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 rTMS | Sham comparator | Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS)Double-blind sham-rTMS in an identical fashion to the active-rTMS condition will be delivered. |
| High Ventral Striatal Reactivity | Other | Diagnostic Test: High Ventral Striatal ReactivityWe 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 | Other | Diagnostic Test: Low Ventral Striatal ReactivityWe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active rTMS |
| 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. | Device | Sham rTMS |
| High Ventral Striatal ReactivityWe 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 ReactivityWe 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 |
Primary outcome
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.
1 secondary outcome
Weeks of opioid abstinance
Time frame: 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory Sahlem principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active repetitive Transcranial Magnetic Stimulation (rTMS), High Ventral Striatal Reactivity and Low Ventral Striatal Reactivity in people with Opioid Use Disorder, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Sahlem ((984) 340-0761, quitopioids@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Relapse Free survival (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.