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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

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

Hand fracture

Restless legs syndrome

Apathy

Head injury

Dyspepsia

Back pain

Speech disorder

Skeletal injury

Tremor

Gait disturbance

Dystonia

Paraesthesia

Influenza

Urinary tract infection

Pain in extremity

Diabetes mellitus

Intervertebral disc protrusion

Spinal osteoarthritis

Fluid retention

Postoperative wound infection

Osteoarthritis

Macular degeneration

Hypoaesthesia

Ingrowing nail

Respiratory depression

Parkinson's disease

Akinesia

Productive cough

Device migration

Syncope

Diplopia

Skin laceration

Joint sprain

Rib fracture

Drug withdrawal syndrome

Alcohol poisoning

Contusion

Cerebral microangiopathy

Dysarthria

Memory impairment

Movement disorder

Monarthritis

Neck pain

Adverse drug reaction

Cyst

Implant site haematoma

Oedema peripheral

Pyrexia

Pleural effusion

Nerve root lesion

Anxiety

Cough

Fibula fracture

Thermal burn

Sciatica

Anger

Bursitis

Cystitis

Helicobacter gastritis

Implant site infection

Localised infection

Pneumonia

Staphylococcal infection

Confusional state

Depressed mood

Hallucination, auditory

Impulse-control disorder

Insomnia

Panic attack

Rapid eye movements sleep abnormal

Bronchitis

Ear infection

Incision site infection

Arthralgia

Axillary pain

Folate deficiency

Hypertension

Hypotension

Thrombophlebitis

Laboratory test abnormal

Weight increased

Pericardial effusion

Seborrhoeic keratosis

Urinary incontinence

100%

80%

60%

40%

20%

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

~700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor

176 Previous Clinical Trials

60,194 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,711 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility criteria for participants to join this clinical experiment?

"Eligibility criteria for this clinical trial requires that interested participants have an opioid use disorder and be between the ages of 22-50. Currently, 20 individuals are sought to take part in the study."

Answered by AI

To what extent is enrollment available for this medical investigation?

"Affirmative. According to the clinical trial listing on clinicaltrials.gov, this medical research is currently seeking participants for its study which was first posted on June 1st 2023 and recently updated last 13th of June. The recruitment needs a total of 20 subjects from one single site."

Answered by AI

Does this research protocol limit enrollment to those aged 75 and under?

"Applicants of this medical trial should be between 22 and 50 years old."

Answered by AI

What is the desired outcome of this research endeavor?

"The primary aim of this trial is to assess opioid use through quantitative urine toxicology over the course of 12 weeks. Secondary objectives include evaluating changes in brain reward circuitry with 18F-fallypride PET scans, non-cue induced substance craving using a visual analog scale (VAS) rating scale from 0 to 10, and cue-induced substance craving via VAS ratings after being exposed to relevant stimuli."

Answered by AI

Are there any open slots for participants in this clinical trial?

"Confirmed; the trial is open for recruitment. Initially posted on June 1st 2023, the study was most recently updated two weeks ago on June 13th."

Answered by AI

Who else is applying?

What site did they apply to?

West Virginia University Rockefeller Neuroscience Institute

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

My addiction to opioids seems to be getting worse despite my constant efforts to stop using. I’ve tried MAT (suboxone, sublocade injections), therapy, approx 15 residential treatment programs, AA meetings etc. I’ve had hospitalizations for overdoses, abscesses and blood infections. The collateral damage on my family, relationships and finances is huge. I don’t want to live like this. I sometimes achieve a month or two clean but my cravings always seem to lead me back. I would not wish this **** on anyone. Please help me.

PatientReceived 2+ prior treatments