Neuromodulation System for Alcoholism

No longer recruiting at 2 trial locations

Overseen By Aaron Miller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Theranova, L.L.C.

Must not be taking: AUD pharmacotherapy

Disqualifiers: Unstable psychiatric disorder, Neurodegenerative disease, Other SUD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for individuals with alcohol use disorder who aim to reduce or quit drinking. The study compares an active neuromodulation system, which uses electrical signals to influence brain activity, with a sham treatment, a placebo that does not affect the brain. It is suitable for those currently diagnosed with alcohol use disorder, consuming moderate to high levels of alcohol daily, and motivated to cut back or stop drinking. Participants should not have other substance use disorders or unstable psychiatric conditions. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take or plan to start taking any alcohol use disorder (AUD) pharmacotherapy during the study, and you must not have changed AUD pharmacotherapy in the past 4 weeks.

Will I have to stop taking my current medications?

The trial requires that participants do not start or change any alcohol use disorder (AUD) medications during the study. If you are currently taking AUD medications, you may need to stop before joining the trial.

What prior data suggests that the Empower Neuromodulation System is safe for treating alcoholism?

Research has shown that neuromodulation techniques, such as the Empower Neuromodulation System, have some evidence supporting their safety for treating alcohol use disorder. However, specific safety data for this system remains limited.

In earlier studies with similar devices, patients generally tolerated the treatment well. This system uses a wearable device with gel pads that adhere to the skin to provide gentle stimulation. While these devices are often considered safe, the specific details for the Empower Neuromodulation System are still under investigation.

For those considering joining a trial, early studies suggest the treatment is generally well-tolerated. However, it is crucial to ask questions and discuss any concerns with the study team before participating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for alcoholism typically involve medications like naltrexone, acamprosate, or disulfiram, which work by altering brain chemistry or creating adverse reactions to alcohol. However, the Empower Neuromodulation System offers a unique approach by using a functional stimulator system to modulate brain activity directly. Researchers are excited because this method targets specific brain regions associated with addiction, potentially offering a more precise and less invasive alternative to traditional medication. Additionally, the system's ability to be fine-tuned for individual needs could lead to more personalized and effective treatment plans.

What evidence suggests that the Empower Neuromodulation System is effective for alcoholism?

Research shows that the Empower Neuromodulation System might help treat alcohol use disorder by reducing cravings and drinking. Previous studies found that this system, which uses signals to stimulate nerves, can affect brain areas involved in craving and reward, crucial in alcohol dependence. In this trial, participants will join either an Active Treatment arm, where the Empower Neuromodulation System delivers functional stimulation, or a Sham Treatment arm, which uses the system in a way believed to have no benefit or harm. The treatment employs a small, battery-powered device with gel pads that send electrical signals to nerves. Early results suggest this can help lessen the urge to drink and ease withdrawal symptoms. While researchers continue to study this method, initial findings are promising for people dealing with alcoholism. ^{1 2 3 4 6}

Who Is on the Research Team?

David Pennington, PhD

Principal Investigator

Northern California Institute of Research and Education

KT Venkateswara-Rao, PhD

Principal Investigator

TheraNova, LLC

Are You a Good Fit for This Trial?

Adults over 21 with alcohol use disorder, drinking at moderate to very high risk levels, who want to reduce or quit alcohol. They must be sober during enrollment and women of childbearing age need a negative pregnancy test. Excluded are those needing medical detox, with recent changes in addiction therapy, metal implants interfering with the device, unstable psychiatric disorders, neurodegenerative diseases, other substance disorders (except nicotine/cannabis), pregnant/breastfeeding women or those not using birth control.

Inclusion Criteria

Individual has a desire to reduce or quit alcohol use

I am 21 years old or older.

Individual has a current diagnosis of alcohol use disorder per DSM-5 via M.I.N.I. assessment by clinician

Exclusion Criteria

Individual has an active implant and/or an implanted electrical or neurostimulator device (e.g., pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)

I experience numbness or tingling in my arm at least once a week.

Individual has a current substance use disorder (SUD) diagnosis other than alcohol, nicotine, or cannabis per DSM-5 via M.I.N.I. assessment by clinician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the active or sham neuromodulation treatment for alcohol use disorder

12 weeks

Weekly visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empower Neuromodulation System

Trial Overview The trial is testing the Empower Neuromodulation System on people with alcoholism. It's conducted across multiple sites where participants are randomly assigned to receive either the actual neuromodulation treatment or a sham (fake) treatment without knowing which one they're getting.

How Is the Trial Designed?

Group I: Active Treatment Active Control 1 Intervention

The Active Treatment will use a functional Stimulator system.

Group II: Sham Treatment Placebo Group 1 Intervention

The Sham Treatment (Placebo) will use a functional Stimulator system, but will provide a treatment in a location that is believed to have no benefit or harm to the subject.

Empower Neuromodulation System is already approved in United States for the following indications:

Approved in United States as Empower Neuromodulation System for:

• Alcohol Use Disorder (AUD)

Who Is Running the Clinical Trial?

Theranova, L.L.C.

Lead Sponsor

Trials

14

Recruited

540+

Published Research Related to This Trial

Neuromodulation is an emerging field that uses electrical, chemical, and mechanical methods to alter the functioning of the nervous system, offering reversible therapies for various conditions including pain, epilepsy, and psychiatric disorders.

The therapy is divided into non-invasive methods (like transcranial magnetic stimulation) and invasive methods (such as deep brain stimulation), highlighting a range of options for treating neurological and psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Invasive neuromodulation in the treatment of drug-resistant epilepsies]. Erőss, L., Entz, L., Fabó, D.[2015]

Auricular transcutaneous vagus nerve stimulation (atVNS) may serve as an effective add-on treatment for alcohol use disorder (AUD) by directly stimulating brain areas that regulate neurotransmitters affected by alcohol, potentially improving cognitive control and aiding in maintaining abstinence.

AtVNS can be easily integrated into daily life as it is a noninvasive technique that can be worn like an earpiece, making it a convenient option for patients who struggle with traditional treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular transcutaneous vagus nerve stimulation for alcohol use disorder: A chance to improve treatment? Konjusha, A., Colzato, L., Ghin, F., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a neuromodulation treatment for alcohol use disorder (AUD), particularly by targeting the salience network in the brain, which is linked to addiction and relapse.

Stimulation of specific brain areas, such as the anterior insula and dorsal anterior cingulate cortex, may enhance the effectiveness of rTMS in reducing relapse rates in individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting the Salience Network: A Mini-Review on a Novel Neuromodulation Approach for Treating Alcohol Use Disorder. Padula, CB., Tenekedjieva, LT., McCalley, DM., et al.[2022]

Current research on neuromodulation techniques like tDCS and rTMS for treating alcohol addiction shows only modest clinical effects, indicating that while there is potential, the efficacy is not yet well-established.

There is a lack of studies on other techniques such as VNS and ECT in alcohol-dependent patients, highlighting the need for more comprehensive research to better understand their potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current perspective of neuromodulation techniques in the treatment of alcohol addiction: a systematic review. Herremans, SC., Baeken, C.[2018]

The NEAT12 device, which uses cranial electrotherapy stimulation (CES) techniques, appears to positively influence brain activity in a 42-year-old male patient recovering from alcohol dependence, particularly by upregulating activity in the Cingulate Gyrus, a region associated with substance use disorders.

Pre- and post-treatment qEEG analysis showed significant changes in brain wave patterns, including a decrease in delta waves and an increase in alpha waves, suggesting that NEAT12 may help normalize electrical activity in the brain during protracted abstinence from alcohol, indicating potential as an anti-craving therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Electroencephalography Analysis (qEEG) of Neuro-Electro-Adaptive Therapy 12™ [NEAT12] Up-Regulates Cortical Potentials in an Alcoholic during Protracted Abstinence: Putative Anti-Craving Implications. Waite, RL., Oscar-Berman, M., RBraverman, E., et al.[2019]

Deep brain stimulation (DBS) targeting the Nucleus Accumbens/Ventral anterior internal capsule was found to be safe for a participant with severe treatment refractory opioid and benzodiazepine use disorders, with no serious adverse events reported over a 12-month follow-up.

DBS significantly reduced substance cravings, particularly for benzodiazepines, and showed trends toward improved executive functions and heart rate variability, suggesting potential benefits for treating substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the nucleus accumbens/ventral capsule for severe and intractable opioid and benzodiazepine use disorder. Mahoney, JJ., Haut, MW., Hodder, SL., et al.[2022]

A double-blind study involving 60 inpatients demonstrated that cranial electrotherapy stimulation (CES) is effective in treating brain dysfunction related to alcoholism and other chemical dependencies, with no observed placebo effect.

CES may serve as a valuable addition to rehabilitation programs for individuals with addiction, positively impacting cognitive areas not typically addressed by standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranial electrotherapy stimulation treatment of cognitive brain dysfunction in chemical dependence. Schmitt, R., Capo, T., Frazier, H., et al.[2015]

Mobile phone systems for treating alcohol-use disorders (AUDs) are categorized into four groups, with comprehensive recovery management systems showing the strongest theoretical support and longest-lasting effects.

While text-messaging applications may offer some benefits, they are likely not sufficient as standalone interventions for AUDs, highlighting the need for more robust and evidence-based solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Delivery of Treatment for Alcohol Use Disorders: A Review of the Literature. Quanbeck, A., Chih, MY., Isham, A., et al.[2022]

Cranial electrotherapy stimulation (CES) was found to significantly improve brain dysfunction in alcoholic patients, particularly on two subscales of the Revised Beta Examination that are linked to brain health.

CES may reduce the recovery time for reversible brain dysfunctions in alcoholics from months or years to just weeks, suggesting it could be a valuable treatment option for enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confirming evidence of an effective treatment for brain dysfunction in alcoholic patients. Smith, RB.[2019]

The Automated Reinforcement Management System (ARMS) aims to enhance treatment for alcohol use disorders (AUD) by providing a customizable and integrated contingency management tool that can be accessed remotely via smartphones, making it particularly beneficial for patients in rural areas.

Provider feedback highlighted the importance of individualized treatment and suggested improvements for ARMS, such as increasing accessibility and enhancing bi-directional communication, to ensure it effectively supports both providers and patients in managing AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Reinforcement Management System (ARMS): focused phase I provider feedback. Smith, CL., Rodin, NM., Hwang, JY., et al.[2022]

Deep brain stimulation (DBS) targeting the nucleus accumbens (NAc) in six patients with severe alcohol use disorder (AUD) led to significant reductions in cravings, alcohol consumption, and alcohol-related compulsivity over 12 months, demonstrating its potential as a safe and effective treatment.

Improvements in compulsive drinking behaviors were linked to reduced glucose metabolism in the NAc and decreased functional connectivity between the NAc and the visual association cortex, suggesting a mechanism by which NAc-DBS may help mitigate the effects of alcohol-related cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the nucleus accumbens in the treatment of severe alcohol use disorder: a phase I pilot trial. Davidson, B., Giacobbe, P., George, TP., et al.[2023]

Naltrexone is an effective treatment for opioid dependence, blocking the effects of opioids and reducing cravings, with mild side effects and no abuse potential, making it a suitable pharmacotherapy.

While its effectiveness in alcohol dependence is moderate, compliance with naltrexone, especially in injectable or implant forms that provide longer-lasting release, shows promise in improving treatment outcomes for alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone depot formulations for opioid and alcohol dependence: a systematic review. Lobmaier, PP., Kunøe, N., Gossop, M., et al.[2021]

Acamprosate significantly improves abstinence rates and cumulative abstinence duration in individuals with alcohol dependence, making it particularly effective for achieving complete abstinence.

Naltrexone effectively reduces relapse rates in the short term but does not significantly increase abstinence rates; it is better suited for programs focused on controlled drinking. Both medications are generally safe and well-tolerated, but compliance remains a challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of naltrexone and acamprosate in the treatment of alcohol dependence: a systematic review. Bouza, C., Angeles, M., Muñoz, A., et al.[2018]

Surgical neuromodulation involves using implantable devices to modify nerve signal transmission, which can help treat chronic pain, spasticity, epilepsy, and other neurological conditions, highlighting its therapeutic potential.

This approach encourages neurosurgeons to adopt advanced neuroengineering techniques, moving beyond traditional surgical methods to restore lost neurological functions, thus opening new avenues for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical neuromodulation: new frontiers in neurosurgery]. Robaina Padrón, FJ.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05948605

Study Details | NCT05948605 | EMPOWER AUD Pivotal Trial The primary effectiveness endpoint will be responder rate at 12 weeks, where a responder is defined as a subject who experiences at least a one level reduction ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03983317

Pilot Evaluation of the Empower Neuromodulation System ... This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD). This is a ...

3. sbir.gov sbir.gov/awards/193650

Award | SBIR We, thus, hypothesize that peripheral nerve stimulation can be an effective treatment for AUD through its direct effects on craving, reward, and withdrawal.

4. reporter.nih.gov reporter.nih.gov/project-details/10266674

burnett, daniel rogers The Empower Neuromodulation System consists of standard, inexpensive TENS gel electrodes and a small, battery- powered signal generator. The goal of this ...

5. withpower.com withpower.com/trial/neuromodulation-system-for-alcoholism-7b638

Neuromodulation System for Alcoholism · Info for Participants ... Empower Neuromodulation System will have tolerable side effects & efficacy for patients with Alcohol Use Disorder, Alcoholism, Alcoholism and Alcohol ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05948605/empower-aud-pivotal-trial

EMPOWER AUD Pivotal Trial | Clinical Research Trial Listing To evaluate the safety and effectiveness of the Empower Neuromodulation System in alcohol use disorder (AUD) patients. The primary safety ...