Deep Brain Stimulation Effects In Patients With Opioid Use Disorder (NCT04354077) | Clinical Trial Compass
RecruitingNot Applicable
Deep Brain Stimulation Effects In Patients With Opioid Use Disorder
United States3 participantsStarted 2022-02-07
Plain-language summary
This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.
Who can participate
Age range
22 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and females age ≥ 22 years with diagnosis of opioid use disorder (OUD) based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) with at least a 5-year history
. OUD must be the primary disorder
. History of ongoing or previous opioid use, relapse, and/or cravings, despite attempts at, or attendance in, at least two different treatment modalities. These modalities may include: Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential treatment, inpatient treatment, alternative to intensive outpatient programs, Drug Dependence Unit programs, medication-assisted treatment (MAT), medication assisted recovery (MAR), inpatient or outpatient rehabilitation, detox programs, Narcotics Anonymous, individual or group therapy, Partial Hospitalization Programs (PHP), Sober living homes, or similar interventions.
. Self-reports ongoing opioid cravings.
. Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves deep brain stimulation, which means brain surgery — can you walk me through what that procedure would actually involve for someone with opioid use disorder, and what the surgical risks look like?
2Since this trial doesn't have a traditional phase number, what does that tell us about how much safety and effectiveness data already exists for using deep brain stimulation specifically for opioid use disorder?
3The trial is measuring opioid use and abstinence as its main outcomes — how would my progress be tracked, and what happens if I relapse or start using again during the study?
4Before considering something as involved as brain surgery, would it make sense for me to try other evidence-based treatments for opioid use disorder first, like medication-assisted treatment with buprenorphine or methadone?
5What kind of long-term follow-up or support would be provided after the deep brain stimulation procedure, and what happens to the device — and my care — once the trial ends?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Opioid use/abstinence
Timeframe: 6 months
2
Opioid use/abstinence
Timeframe: 1 year post-surgery
Trial details
NCT IDNCT04354077
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
. Has completed a psychiatric evaluation to the satisfaction of a psychiatrist
. Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified
. Platelet count \> 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
Exclusion criteria
. Prior brain surgery
. Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or moderate risk of suicide based upon a score of 3 or greater on the Columbia Suicide Severity Scale, unless clinical judgment indicates that the individual is appropriate for inclusion despite these scores.
. History of uncontrolled or persistent seizures
. Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score \< 25
. Contraindications for MRI:
. Presence of implanted electrical stimulation device or other implanted metal devices (excluding dental braces).
. Claustrophobia
. Body weight exceeding limit of the machine (180 kg/400 lb)