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Procedure

Deep Brain Stimulation for Opioid Addiction

N/A
Recruiting
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 outpatient week 12
Awards & highlights

Summary

This trial tests the safety and effectiveness of a brain stimulator to treat opioid addiction in those with cognitive, behavioral, and functional disabilities.

Who is the study for?
This trial is for adults aged 22-50 with severe opioid use disorder (OUD) that hasn't improved after five years of trying other treatments. They must have survived an overdose and can have other substance use disorders, but OUD should be their main issue.Check my eligibility
What is being tested?
The study is testing Deep Brain Stimulation (DBS) on two brain areas: the nucleus accumbens and ventral internal capsule. It aims to see if DBS is safe, tolerable, and could work as a new treatment for people whose OUD doesn't respond to existing therapies.See study design
What are the potential side effects?
Potential side effects of DBS may include headache, nausea, bleeding or infection at the implant site, mood changes, or unintended movements. These vary by individual and some might only occur during adjustment periods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outpatient week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and outpatient week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid use assessed via quantitative urine toxicology
Safety and tolerability as measured by all adverse events related to DBS
Secondary outcome measures
Changes in Cognitive Functioning (Executive Functioning: Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting)
Changes in Cognitive Functioning (NIH Toolbox Cognition Battery)
Changes in Cognitive Functioning (Standard Neuropsychological Battery)
+5 more

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948
23%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Head injury
5%
Dyspepsia
5%
Back pain
5%
Speech disorder
5%
Skeletal injury
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Akinesia
3%
Parkinson's disease
3%
Syncope
3%
Device migration
3%
Hypoaesthesia
3%
Respiratory depression
3%
Postoperative wound infection
3%
Intervertebral disc protrusion
3%
Pain in extremity
3%
Spinal osteoarthritis
3%
Osteoarthritis
3%
Macular degeneration
3%
Productive cough
3%
Diabetes mellitus
3%
Ingrowing nail
3%
Fluid retention
3%
Diplopia
3%
Skin laceration
3%
Joint sprain
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Alcohol poisoning
3%
Contusion
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Adverse drug reaction
3%
Cyst
3%
Implant site haematoma
3%
Oedema peripheral
3%
Pyrexia
3%
Pleural effusion
3%
Nerve root lesion
3%
Anxiety
3%
Cough
3%
Fibula fracture
3%
Thermal burn
3%
Sciatica
3%
Anger
3%
Bursitis
3%
Cystitis
3%
Helicobacter gastritis
3%
Implant site infection
3%
Localised infection
3%
Pneumonia
3%
Staphylococcal infection
3%
Confusional state
3%
Depressed mood
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Insomnia
3%
Panic attack
3%
Rapid eye movements sleep abnormal
3%
Bronchitis
3%
Ear infection
3%
Incision site infection
3%
Arthralgia
3%
Axillary pain
3%
Folate deficiency
3%
Hypertension
3%
Hypotension
3%
Thrombophlebitis
3%
Laboratory test abnormal
3%
Weight increased
3%
Pericardial effusion
3%
Seborrhoeic keratosis
3%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deep Brain Stimulation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DBS-ONExperimental Treatment1 Intervention
Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment o OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team.
Group II: DBS-OFFPlacebo Group1 Intervention
For participants randomized to the "DBS-OFF" condition, titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered and therefore, no actual adjustments made
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~710

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Opioid Use Disorder (OUD) include pharmacological approaches like methadone, buprenorphine, and naltrexone, which interact with opioid receptors to reduce cravings and withdrawal symptoms. Methadone and buprenorphine are partial agonists that activate opioid receptors to a lesser extent, while naltrexone is an antagonist that blocks these receptors. Neuromodulation treatments, such as Deep Brain Stimulation (DBS), target brain regions like the nucleus accumbens and ventral internal capsule to modulate neural activity, aiming to alter the brain's reward and addiction pathways. These mechanisms are crucial for OUD patients as they help address both the physiological and psychological aspects of addiction, improving treatment outcomes.
The effects of buprenorphine on fentanyl withdrawal in rats.Presynaptic versus postsynaptic localization of mu and delta opioid receptors in dorsal and ventral striatopallidal pathways.Fentanyl increases dopamine release in rat nucleus accumbens: involvement of mesolimbic mu- and delta-2-opioid receptors.

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor
178 Previous Clinical Trials
63,014 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,563 Total Patients Enrolled
James Mahoney, PhDStudy DirectorWVU Rockefeller Neuroscience Institute

Media Library

Deep Brain Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05903495 — N/A
Opioid Use Disorder Research Study Groups: DBS-ON, DBS-OFF
Opioid Use Disorder Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT05903495 — N/A
Deep Brain Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05903495 — N/A
~11 spots leftby Dec 2025