OUD Target Trial (Opioid Use Disorder)

Purpose of this Study

We are doing this study to improve treatment options for people with opioid use disorder. We want to know if a certain brain signal can better predict how someone will respond to buprenorphine (Suboxone®), and we also want to find out if a non-invasive treatment called repetitive Transcranial Magnetic Stimulation (rTMS) can help people quit opioids more easily than just taking buprenorphine alone. rTMS involves placing a coil against the scalp, and delivers magnetic pulses that stimulate a specific part of the brain. For this study, we will focus on the part of the brain involved with self-control. This procedure is FDA-approved for depression and is commonly used in other addiction treatments (smoking cessation).

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with opioid use disorder
  • Plan to use buprenorphine to reduce cravings
  • Do not have a diagnosis of bipolar disorder, schizophrenia, or a history of epilepsy/seizures
  • Do not have any metal implants in their body above the neck
  • Are not pregnant or breastfeeding
For more information, contact the study team at cameron.howes@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join the study, we will schedule you to come in for a screening visit to find out if you are eligible. If you are eligible, you will get a random assignment (like a coin flip) to either get the rTMS procedure or a sham (fake) version of the procedure. You will not know the group you are in until the study is over. No matter your group assignment, during the study you will:
  • Have MRI brain scans (before starting buprenorphine, 7-10 days after starting buprenorphine, and after finishing rTMS/sham sessions)
  • Have 50 one-hour rTMS/sham sessions (flexible scheduling)
  • Have brief check-ins once a week for 12 weeks after your rTMS/sham sessions (most can be done online)
You can learn more and contact the study team online: https://redcap.duke.edu/redcap/surveys/?s=LEA4JYWJJJ7KKYCC

Locations

Duke University Hospital
Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

The Development and Validation of Neural Targets in Opioid Use Disorder

Study Website

Study Website

Principal Investigator

Gregory
Sahlem

Protocol Number

PRO00116151

NCT ID

NCT06585709

Enrollment Status

Open to Enrollment
ClinicalTrials.gov