OUD Target Trial (Opioid Use Disorder) - Clinical Trial

What is the 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).

What is the Condition Being Studied?

Opioid Use Disorder

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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

Study Details

Full Title
The Development and Validation of Neural Targets in Opioid Use Disorder
Principal Investigator
Gregory Sahlem
Protocol Number
IRB: PRO00116151
NCT: NCT06585709
ClinicalTrials.gov
Enrollment Status
Open for Enrollment