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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 1 year post-surgery
Awards & highlights

Summary

This trial will test whether deep brain stimulation of the nucleus accumbens can help people with treatment-resistant opioid use disorder who are actively participating in a drug addiction treatment program.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~1 year post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid use/abstinence
Secondary outcome measures
Changes in biochemical markers of health
Changes in biochemical markers of nutrition
Depression score
+1 more
Other outcome measures
Primary Safety Objective - Complication rates

Trial Design

1Treatment groups
Experimental Treatment
Group I: NAc DBSExperimental Treatment1 Intervention
Subjects will receive bilateral DBS of the NAc

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.

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor
752 Previous Clinical Trials
478,362 Total Patients Enrolled
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
47 Previous Clinical Trials
12,951 Total Patients Enrolled
Nestor Tomycz, MDPrincipal InvestigatorAllegheny Health Network
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

DBS of the NAc Clinical Trial Eligibility Overview. Trial Name: NCT04354077 — N/A
Opioid Use Disorder Research Study Groups: NAc DBS
Opioid Use Disorder Clinical Trial 2023: DBS of the NAc Highlights & Side Effects. Trial Name: NCT04354077 — N/A
DBS of the NAc 2023 Treatment Timeline for Medical Study. Trial Name: NCT04354077 — N/A
~1 spots leftby Feb 2025