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Deep Brain Stimulation
Deep Brain Stimulation for Opioid Use Disorder (DBS_OUD Trial)
N/A
Waitlist Available
Led By Ali R Rezai, MD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 - 52 weeks
Awards & highlights
DBS_OUD Trial Summary
This trial is testing a new treatment for people with opioid addiction who haven't responded to other treatments. The goal is to see if it's safe and works better than other treatments.
DBS_OUD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 - 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 - 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Opioid Use
Incidence of Study-Emergent Adverse Events
Secondary outcome measures
Incidence of Serious Infectious Disease Complications
Mood, Craving and Executive Function
Participant Survival
+1 moreOther outcome measures
Changes in Dopamine
Frontal Lobe Metabolism
DBS_OUD Trial Design
1Treatment groups
Experimental Treatment
Group I: OUD DBSExperimental Treatment1 Intervention
This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.
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Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,589 Total Patients Enrolled
West Virginia UniversityLead Sponsor
175 Previous Clinical Trials
56,302 Total Patients Enrolled
MedtronicIndustry Sponsor
605 Previous Clinical Trials
828,191 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a stroke caused by bleeding in the brain.You have a medical condition that requires diathermy treatment.You are currently taking medication to prevent blood clots.You had a heart attack or cardiac arrest in the last 6 months.You have had two instances of overdosing or one instance of overdosing and one severe infection that required treatment in the past year, with the infection coming back even after treatment.We want to make sure you have people in your life who can help and support you during the study.You have a device called a neurostimulator implanted in your body.Participants may have comorbid SUD diagnoses at mild, moderate or severe levels, however OUD must be the primary disorder for which the individual is seeking treatment and the other use disorders must occur in the context of relapse.You have serious medical conditions that need constant medical attention or tests.You have had a brain surgery in the past.You have any medical reasons that make it unsafe for you to have deep brain stimulation (DBS) surgery.Your doctor believes you have less than 3 years to live.You have been diagnosed with schizophrenia, bipolar disorder, or severe depression that is not related to substance use. If you have been treated for depression, it should have been in remission for at least one year.You have a high level of depression or show signs of being at risk for suicide.You have certain types of personality disorders known as Cluster A or B.You have been diagnosed with dementia.You have a past or current neurological disorder.You have tried to harm yourself in the past.One of your parents has died by suicide.You have had two instances of overdosing on drugs or one instance of overdosing and one serious infection that required treatment and then came back within the past year.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Arizona
What site did they apply to?
West Virginia University Rockefeller Neuroscience Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I've tried most available types of treatment with inpatient and outpatient with Suboxone multiple times and just feel I've exhausted all other options and desperate to try something new that may work to fix me or aid me into finally some relief after 13+ miserable years of no joy or pleasure or happiness. Please help.
PatientReceived 2+ prior treatments
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