What side effects are associated with this type of intervention?

Deep Brain Stimulation (DBS) for Opioid Use Disorder (OUD) can cause side effects such as infection, hemorrhage, confusion, seizures, and hardware malfunctions, though these are generally rare and often reversible. Other common treatments like methadone, buprenorphine, and naltrexone can lead to side effects including constipation, nausea, drowsiness, and potential dependency. Psychosocial treatments like cognitive-behavioral therapy (CBT) and contingency management are generally well-tolerated but may cause emotional distress as patients confront their addiction.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder, including buprenorphine, naltrexone, and methadone. Buprenorphine partially activates opioid receptors, naltrexone blocks these receptors, and methadone fully activates them in a controlled manner. These medications help manage cravings and withdrawal symptoms. While Deep Brain Stimulation (DBS) of the Nucleus Accumbens is being studied for its potential to modulate neural circuits associated with addiction and reward, it is not yet FDA-approved for OUD.

What other types of research exist?

Promising novel alternatives to Deep Brain Stimulation for opioid use disorder include Transcranial Magnetic Stimulation (TMS) and Vagus Nerve Stimulation (VNS). TMS has shown efficacy in various mood and addiction disorders, while VNS has demonstrated positive outcomes in treatment-resistant depression and rapid-cycling bipolar disorder, which may translate to benefits in opioid use disorder.

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Deep Brain Stimulation for Opioid Use Disorder

N/A

Recruiting

Led By Nestor Tomycz, MD

Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has exhibited more than 2 episodes of opioid use relapse in prior 12 months despite ongoing participation in MAT program, including either methadone or buprenorphine or suboxone

Failed at least two levels of treatment (Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential, inpatient, alternative to intensive outpatient program, Drug Dependence Unit, which included buprenorphine/naloxone or buprenorphine monotherapy

Must not have

Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI

Any evidence of underlying endocarditis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 9, 12 and 24 months post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a brain device that sends electrical signals to help people with severe opioid addiction who don't respond to usual treatments. The device aims to reduce cravings and prevent relapse by targeting a specific brain area involved in addiction.

Who is the study for?

This trial is for adults over 22 with a primary diagnosis of opioid use disorder (OUD) based on DSM-V, who have struggled with OUD for at least 5 years and failed multiple treatments. Participants must not have severe psychiatric disorders or other substance abuse issues, should be in good physical health without serious infections or blood clotting problems, and cannot be pregnant.

What is being tested?

The study tests deep brain stimulation (DBS) of the nucleus accumbens (NAc) as an additional treatment for those with hard-to-treat opioid addiction. It will include only three individuals who continue to relapse despite being in a drug treatment program.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, headache, nausea, changes in mood or behavior due to brain stimulation, and risks associated with any surgical procedure like infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have relapsed on opioids more than twice in the last year despite being in a treatment program.

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I have tried at least two different treatments for opioid addiction without success.

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I am 22 or older and have been diagnosed with opioid use disorder for at least 5 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe brain shrinkage or fluid/blood under my skull's lining.

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I have signs of heart valve infection.

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I have had brain surgery before.

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I have a history of seizures that are not well-controlled.

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I have a blood clotting disorder due to long-term use of blood thinners.

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I have been diagnosed with a neurological disorder like MS, Parkinson's, or had a stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 9, 12 and 24 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 9, 12 and 24 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 9, 12 and 24 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid use/abstinence

Secondary study objectives

Changes in biochemical markers of health

Changes in biochemical markers of nutrition

Depression score

+1 more

Other study objectives

Primary Safety Objective - Complication rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NAc DBSExperimental Treatment1 Intervention

Subjects will receive bilateral DBS of the NAc

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Opioid Use Disorder (OUD) include methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are opioid agonists that work by binding to opioid receptors in the brain, reducing cravings and withdrawal symptoms without producing the same high as other opioids. Naltrexone is an opioid antagonist that blocks opioid receptors, preventing the euphoric effects of opioids. These treatments are crucial for OUD patients as they help stabilize brain chemistry, reduce illicit opioid use, and support recovery. Deep Brain Stimulation (DBS) of the Nucleus Accumbens (NAc) targets neural circuits associated with addiction and reward, potentially offering an adjunctive treatment by modulating these pathways to reduce cravings and compulsive drug-seeking behaviors.

Long-term antagonism of κ opioid receptors prevents escalation of and increased motivation for heroin intake.