Deep Brain Stimulation for Opioid Use Disorder
(DBS_OUD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAli Rezai

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?The purpose of this clinical study is to investigate the safety, tolerability, and feasibility of Deep Brain Stimulation (DBS) of the nucleus accumbens (NAc) and ventral internal capsule (VC) for participants with treatment refractory opioid use disorder (OUD) who have cognitive, behavioral, and functional disability. This study will also provide critical information for planning subsequent clinical trials.

Eligibility Criteria

This trial is for adults with severe opioid use disorder (OUD) who have tried multiple treatments without success, including buprenorphine/naloxone. They should have a history of at least two overdoses or one overdose and a serious infection related to drug use. Participants need social support and cannot be pregnant, have certain brain conditions, HIV, or be on anticoagulants.

Inclusion Criteria

Is able to provide informed consent

Fulfills current DSM-5 diagnostic criteria for OUD (severe) and at least a 5-year history

Failed at least two levels of treatment (outpatient/Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient/intensive COAT, residential, inpatient, Adult Intensive Outpatient Program (AIOP), Dual Diagnosis Unit (DDU), which included buprenorphine/naloxone

+5 more

Exclusion Criteria

Pregnant or planning to become pregnant

You have had a stroke caused by bleeding in the brain.

Any current CNS infection or infection with the Human Immunodeficiency Virus (HIV)

+22 more

Participant Groups

The study tests the safety and feasibility of Deep Brain Stimulation (DBS) targeting specific brain areas in people with treatment-resistant OUD. It aims to provide information for future trials by assessing how well participants tolerate DBS and its initial effectiveness.

1Treatment groups

Experimental Treatment

Group I: OUD DBSExperimental Treatment1 Intervention

This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.

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: