Neuromodulation System for Alcoholism

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

128 Participants Needed

Trial Summary

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 data supports the idea that Neuromodulation System for Alcoholism is an effective treatment?

The available research shows that cranial electrotherapy stimulation (CES), a type of neuromodulation, is effective in treating brain dysfunction associated with alcoholism. Studies have found that CES leads to significant improvements in brain function for alcoholic patients, reducing recovery time from months or years to just weeks. This suggests that CES can be a valuable part of rehabilitation programs for those struggling with alcohol addiction. Compared to other treatments like mobile apps or text-based interventions, CES has shown more concrete evidence of effectiveness in improving brain function. ^{1 2 3 4 5}

What data supports the effectiveness of the Empower Neuromodulation System treatment for alcoholism?

Research shows that cranial electrotherapy stimulation (CES), a type of neuromodulation, is effective in improving brain function in people with alcoholism. CES has been found to significantly reduce brain dysfunction symptoms in alcoholic patients, suggesting it could be a valuable part of treatment programs. ^{1 2 3 4 5}

What safety data is available for the Neuromodulation System for Alcoholism?

The provided research does not directly mention the Empower Neuromodulation System or similar devices specifically for alcoholism. However, it discusses related neuromodulation techniques like deep brain stimulation (DBS) of the nucleus accumbens, which has been found to be feasible and safe in patients with severe alcohol use disorder, showing reductions in cravings and addictive behavior without significant adverse events. Additionally, cranial electrotherapy stimulation (CES) is mentioned as a noninvasive therapy with a controversial effectiveness record, but no specific safety data is provided for the NEAT12 device. Overall, while there is some evidence supporting the safety of neuromodulation techniques in treating alcohol use disorder, specific safety data for the Empower Neuromodulation System is not available in the provided research. ^{6 7 8 9 10}

Is the Neuromodulation System for Alcoholism safe for humans?

Deep brain stimulation (DBS) of the nucleus accumbens has been found to be safe in patients with severe alcohol use disorder, with no significant adverse events reported. This suggests that similar neuromodulation systems may also be generally safe in humans. ^{6 7 8 9 10}

Is the Empower Neuromodulation System a promising treatment for alcoholism?

Yes, the Empower Neuromodulation System is a promising treatment for alcoholism. It uses advanced brain stimulation techniques to help people regain control over their alcohol intake, potentially reducing relapse rates and improving cognitive functions. This approach targets specific brain networks involved in addiction, offering a new way to support recovery. ^{2 11 12 13 14}

How is the Empower Neuromodulation System treatment different from other treatments for alcohol use disorder?

The Empower Neuromodulation System is unique because it uses neuromodulation, a technique that alters brain activity, to target specific brain networks involved in alcohol use disorder, such as the salience network. This approach is different from traditional treatments, which often rely on medication or therapy, and offers a novel way to potentially reduce relapse rates by directly influencing brain circuits associated with addiction. ^{2 11 12 13 14}

What is the purpose of this trial?

Multi-site, double-blinded, prospective, randomized, sham-controlled study

Research Team

KT Venkateswara-Rao, PhD

Principal Investigator

TheraNova, LLC

David Pennington, PhD

Principal Investigator

Northern California Institute of Research and Education

Eligibility Criteria

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 breath alcohol concentration of 0.02% or less at enrollment

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cranial electrotherapy stimulation treatment of cognitive brain dysfunction in chemical dependence. [2015]

2. Croatia pubmed.ncbi.nlm.nih.gov

The current perspective of neuromodulation techniques in the treatment of alcohol addiction: a systematic review. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Mobile Delivery of Treatment for Alcohol Use Disorders: A Review of the Literature. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Automated Reinforcement Management System (ARMS): focused phase I provider feedback. [2022]

6. United States 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. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Naltrexone depot formulations for opioid and alcohol dependence: a systematic review. [2021]

8. England 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the nucleus accumbens/ventral capsule for severe and intractable opioid and benzodiazepine use disorder. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of naltrexone and acamprosate in the treatment of alcohol dependence: a systematic review. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting the Salience Network: A Mini-Review on a Novel Neuromodulation Approach for Treating Alcohol Use Disorder. [2022]

12. Hungary pubmed.ncbi.nlm.nih.gov

[Invasive neuromodulation in the treatment of drug-resistant epilepsies]. [2015]

13. Spain pubmed.ncbi.nlm.nih.gov

[Surgical neuromodulation: new frontiers in neurosurgery]. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Auricular transcutaneous vagus nerve stimulation for alcohol use disorder: A chance to improve treatment? [2022]