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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-surgery
Awards & highlights
Study 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 belowSelect...
I have relapsed on opioids more than twice in the last year despite being in a treatment program.
Select...
I have tried at least two different treatments for opioid addiction without success.
Select...
I am 22 or older and have been diagnosed with opioid use disorder for at least 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-surgery
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 moreOther 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
Find a Location
Who is running the clinical trial?
AbbottIndustry Sponsor
751 Previous Clinical Trials
478,447 Total Patients Enrolled
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
47 Previous Clinical Trials
13,076 Total Patients Enrolled
Nestor Tomycz, MDPrincipal InvestigatorAllegheny Health Network
1 Previous Clinical Trials
40 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe brain shrinkage or fluid/blood under my skull's lining.I have signs of heart valve infection.I survived at least two overdoses or had one overdose and a severe infection needing treatment in the past year.I have relapsed on opioids more than twice in the last year despite being in a treatment program.I have had brain surgery before.I have tried at least two different treatments for opioid addiction without success.I have a history of seizures that are not well-controlled.I have a blood clotting disorder due to long-term use of blood thinners.I am 22 or older and have been diagnosed with opioid use disorder for at least 5 years.I have been diagnosed with a neurological disorder like MS, Parkinson's, or had a stroke.I am not pregnant or nursing, can have a negative pregnancy test, and will use birth control during and after the trial.
Research Study Groups:
This trial has the following groups:- Group 1: NAc DBS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this trial restricted to those under 45 years of age?
"Subjects between 22 and 65 years old are being welcomed to partake in this trial."
Answered by AI
Are investigators currently recruiting participants for this experiment?
"That is correct. According to documents on clinicaltrials.gov, this clinical trial was initially posted on February 7th 2022 and last updated on the 9th of that same month. The recruitment process involves 3 individuals from one medical centre."
Answered by AI
Who would be the ideal candidate for this medical experiment?
"This clinical trial is searching for 3 individuals, between the ages of 22 and 65 who are currently experiencing issues related to drug abuse. To be eligible, subjects must meet certain criteria: an OUD diagnosis as their primary disorder; failed multiple treatment levels including buprenorphine/naloxone or buprenorphine monotherapy; at least two overdoses or one overdose with another life-threatening infection within the past year; refractory symptoms persisting over 5 years; lack of active illicit substance use (verified through urine tests); a psychiatric evaluation approved by a psychiatrist; completion of neuropsychological evaluations conducted by a neuropsych"
Answered by AI
What is the current participant count for this research investigation?
"Indeed, according to the information accessible on clinicaltrials.gov this trial is currently in search of participants. Initially published on February 7th 2022 and last refreshed on the 9th of that same month, 3 patients are sought from a single location."
Answered by AI
Who else is applying?
What site did they apply to?
AHN Allegheny General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Over the last 15 years I’ve tried everything to fight my addiction: multiple residential treatment programs (with detox, 30 days in residential, followed by months in PHP, IOP, sober living and aftercare). I’ve tried methadone, buprenorphine pills, monthly sublocade injections. Individual and group talk therapy, daily 12-Step/AA/NA meetings.
I’ve been hospitalised for near fatal overdoses and abscesses. I’ve been incarcerated, been on the streets, crashed 3 cars and lost all my money and friends.
I’m motivated to try anything which will help my constant struggle to stay in recovery.
DBS treatment for OUD gives me hope. It could save my life. Please help 🙏.
PatientReceived 1 prior treatment
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