Deep Brain Stimulation for Opioid Addiction

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.

Research Team

James Mahoney, PhD

Principal Investigator

WVU Rockefeller Neuroscience Institute

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

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

Treatment Details

Interventions

• Deep Brain Stimulation (Procedure)

Trial Overview 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.

Participant Groups

Group I: DBS-ON Experimental Treatment 1 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-OFF Placebo Group 1 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 Canada for the following indications:

Approved in Canada as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Dr. William P. Petros

West Virginia University

Chief Medical Officer

PharmD from West Virginia University

Dr. Clay B. Marsh

West Virginia University

Chief Executive Officer since 2015

MD from West Virginia University, Bachelor’s in Biology from West Virginia University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico