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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
Study 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ outpatient week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outpatient week 12
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 moreSide effects data
From 2018 Phase 2 trial • 53 Patients • NCT0122194823%
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%
Pain in extremity
3%
Intervertebral disc protrusion
3%
Spinal osteoarthritis
3%
Hypoaesthesia
3%
Fluid retention
3%
Productive cough
3%
Postoperative wound infection
3%
Osteoarthritis
3%
Macular degeneration
3%
Ingrowing nail
3%
Respiratory depression
3%
Parkinson's disease
3%
Akinesia
3%
Syncope
3%
Device migration
3%
Diabetes mellitus
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
Find a Location
Who is running the clinical trial?
West Virginia UniversityLead Sponsor
177 Previous Clinical Trials
62,171 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,485 Previous Clinical Trials
2,622,360 Total Patients Enrolled
James Mahoney, PhDStudy DirectorWVU Rockefeller Neuroscience Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 22 and 50 years old.I had a heart attack or cardiac arrest in the last 6 months.I have been diagnosed with schizophrenia, bipolar disorder, or severe depression.I have had symptoms of opioid use disorder for over five years.I am between 22 and 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: DBS-ON
- Group 2: DBS-OFF
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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