The Development and Validation of Neural Targets in Opioid Use Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Contact Information
Primary
Gregory Sahlem
quitopioids@duke.edu
(984) 340-0761
Time Frame
Start Date: 2024-12-31
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 80
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Stanford University
Leads: Duke University

This content was sourced from clinicaltrials.gov