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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 12 - 52 weeks
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adults with severe opioid use disorder (OUD) who have tried multiple treatments without success, including buprenorphine/naloxone. They should have a history of at least two overdoses or one overdose and a serious infection related to drug use. Participants need social support and cannot be pregnant, have certain brain conditions, HIV, or be on anticoagulants.
What is being tested?
The study tests the safety and feasibility of Deep Brain Stimulation (DBS) targeting specific brain areas in people with treatment-resistant OUD. It aims to provide information for future trials by assessing how well participants tolerate DBS and its initial effectiveness.
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 stimulation of brain regions, bleeding into the brain tissue during surgery, and possible infection risks associated with surgical procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 - 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 - 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Opioid Use
Total Number of Study-Emergent Adverse Events
Secondary study objectives
Incidence of Serious Infectious Disease Complications
Mood, Craving and Executive Function
Participant Survival
+1 moreOther study objectives
Changes in Dopamine
Frontal Lobe Metabolism
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,586 Previous Clinical Trials
3,328,526 Total Patients Enrolled
West Virginia UniversityLead Sponsor
185 Previous Clinical Trials
64,769 Total Patients Enrolled
MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,084 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.
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