BridgeMD
New treatment option for Opioid-use Disorder
Official title Deep Brain Stimulation Effects In Patients With Opioid Use Disorder
ClinicalTrials.gov ID: NCT04354077
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Male and females age ≥ 22 years with diagnosis of opioid use disorder (OUD) based on Diagnostic and Statistical Manual of Mental Disorders, fifth...
- 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...
- Self-reports ongoing opioid cravings.
- Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
You likely can't join if
- 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...
- 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).
See the full eligibility 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...
- Self-reports ongoing opioid cravings.
- Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
- 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
- Negative blood cultures to rule out bacteremia
- 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...
- 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)
- Females who are pregnant or nursing. Female people of child-bearing potential must have a negative pregnancy test during the pre-op phase and must agree to utilize adequate birth control throughout the trial and for at...
- Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)
- Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)
- Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI
- Any evidence of underlying endocarditis.
- Primary language other than English
- Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.