What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder include medication-assisted treatments (MAT) such as methadone, buprenorphine, and naltrexone, which can cause side effects like constipation, nausea, drowsiness, and potential dependency. Neuromodulation therapies, such as Deep Brain Stimulation (DBS) targeting the nucleus accumbens and ventral internal capsule, are being studied for treatment-refractory OUD. Known side effects of DBS include infection, hemorrhage, confusion, seizures, and hardware malfunctions, though severe adverse effects are uncommon and often reversible by adjusting the stimulation parameters.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for Opioid Use Disorder, including methadone, buprenorphine, and naltrexone. These medications work by targeting opioid receptors to reduce cravings and withdrawal symptoms. While Deep Brain Stimulation (DBS) is being studied for its potential in modulating neural activity in the nucleus accumbens and ventral internal capsule for treatment-refractory OUD, it is not yet FDA-approved for this indication. DBS represents a more invasive approach compared to the currently approved pharmacotherapies, which are non-invasive and focus on receptor modulation rather than direct neural stimulation.

What other types of research exist?

Promising novel alternatives to Deep Brain Stimulation for Opioid Use Disorder patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown potential in treating addiction. 2) Vagus Nerve Stimulation (VNS), which involves electrical stimulation of the vagus nerve and has been explored for its effects on mood and addiction. 3) Pharmacological advancements such as the use of novel medications targeting specific neural pathways involved in addiction, including NMDA receptor antagonists like ketamine. These alternatives offer non-invasive or less invasive options compared to DBS and are being actively researched for their efficacy in treating OUD.

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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

Summary

This trial is testing a device that sends electrical signals to the brain to help people with severe opioid addiction who haven't been helped by other treatments. The device aims to control brain areas involved in addiction and behavior. Current experimental evidence indicates that this method has excellent potential to help with treatment, showing fewer side effects and better adherence.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid use assessed via quantitative urine toxicology

Safety and tolerability as measured by all adverse events related to DBS

Secondary study objectives

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

Dyspepsia

Back pain

Skeletal injury

Head injury

Speech disorder

Tremor

Gait disturbance

Dystonia

Paraesthesia

Influenza

Urinary tract infection

Osteoarthritis

Ingrowing nail

Postoperative wound infection

Diabetes mellitus

Pain in extremity

Spinal osteoarthritis

Alcohol poisoning

Intervertebral disc protrusion

Hypoaesthesia

Diplopia

Contusion

Productive cough

Joint sprain

Macular degeneration

Fluid retention

Device migration

Skin laceration

Akinesia

Parkinson's disease

Syncope

Respiratory depression

Rib fracture

Drug withdrawal syndrome

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

~710

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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.