Deep Brain Stimulation for Opioid Addiction

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: West Virginia University

No Placebo Group

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a device that sends electrical signals to the brain to help people with severe opioid addiction who haven't been helped by other treatments. The device aims to control brain areas involved in addiction and behavior. Current experimental evidence indicates that this method has excellent potential to help with treatment, showing fewer side effects and better adherence.

Eligibility Criteria

This trial is for adults aged 22-50 with severe opioid use disorder (OUD) that hasn't improved after five years of trying other treatments. They must have survived an overdose and can have other substance use disorders, but OUD should be their main issue.

Inclusion Criteria

I am between 22 and 50 years old.

Demonstrated greater than five years of refractory symptoms of OUD

Fulfills current DSM-5 diagnostic criteria for severe OUD with at least a 5-year history

+2 more

Exclusion Criteria

I had a heart attack or cardiac arrest in the last 6 months.

I have been diagnosed with schizophrenia, bipolar disorder, or severe depression.

Unable to undergo MR-imaging

Participant Groups

The study is testing Deep Brain Stimulation (DBS) on two brain areas: the nucleus accumbens and ventral internal capsule. It aims to see if DBS is safe, tolerable, and could work as a new treatment for people whose OUD doesn't respond to existing therapies.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DBS-ONExperimental Treatment1 Intervention

Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment o OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team.

Group II: DBS-OFFPlacebo Group1 Intervention

For participants randomized to the "DBS-OFF" condition, titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered and therefore, no actual adjustments made

Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Deep Brain Stimulation for: