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Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

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ClinicalTrials.gov Identifier: NCT03983317
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Northern California Institute of Research and Education
Information provided by (Responsible Party):
Theranova, L.L.C.

Brief Summary:
This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD). This is a pilot investigation in which all participants will receive the active treatment.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Device: Empower Neuromodulation System Not Applicable

Detailed Description:
Alcohol use disorder (AUD) is a major public health concern, affecting over 16 million Americans. Peripheral nerve stimulation via acupuncture has been shown to directly decrease alcohol craving and self-administration. TheraNova has developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of AUD. In this study, we will conduct a cross-over, home-use study in participants with AUD. Participants will have a one-week control period with no treatment followed by two weeks of twice daily treatment with the Empower device. We will evaluate endpoints for safety and effectiveness.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants will have a one-week control period with no treatment followed by two weeks of twice daily Empower treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
No Intervention: Baseline
For the first week of the study, participants will not administer treatment with the Empower device. Participants will complete surveys to establish baseline values for each participant.
Experimental: Active treatment
Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment.
Device: Empower Neuromodulation System
Transcutaneous electrical nerve stimulation




Primary Outcome Measures :
  1. Obsessive compulsive drinking scale (OCDS) score [ Time Frame: 3 weeks ]
    Change in the obsessive compulsive drinking scale (OCDS) score. The OCDS is a 14-item, self-report questionnaire that measures alcohol-related craving. The OCDS has a minimum score of 0 (no craving) and a maximum score of 56 (severe craving).

  2. Adverse events [ Time Frame: 3 weeks ]
    Safety assessment via device-related adverse events


Secondary Outcome Measures :
  1. Alcohol craving score [ Time Frame: 3 weeks ]
    Change in alcohol craving intensity via 100-mm visual-analog scale (VAS). The VAS has a minimum score of 0 (no craving) and a maximum score of 100 (severe craving).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is male or female ≥ 21 year of age at Visit 1
  • Has a current diagnosis of alcohol use disorder per DSM-5 by clinician assessment
  • Endorses Criterion 4 in DSM-5
  • Has a desire to maintain abstinence or, if not abstinent, a desire to reduce or quit alcohol use
  • Has a breath alcohol concentration of 0.00% at enrollment
  • Is able to provide informed consent
  • Is able to understand spoken and written English
  • Is capable and willing to follow all study-related procedures

Exclusion Criteria:

  • Has been diagnosed with unstable psychosis, epilepsy, peripheral neuropathy, or nerve damage
  • Requires acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)
  • Has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
  • Has an electrically conductive metal object (e.g. jewelry) that cannot be removed from the palm and will directly contact the gel electrodes of the Empower Neuromodulation System
  • Will not, for the duration of the participation in the study, have a living situation that provides regular access to an electrical outlet.
  • Is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
  • Has a bleeding disorder, a history of deep vein thrombosis, or is on anticoagulation drugs
  • Has used an investigational drug/device therapy within the past 4 weeks
  • Is deemed unsuitable for enrollment in the study by the PI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983317


Contacts
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Contact: Michael Vice President 4159268616 clinicalstudy@theranova.com

Locations
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United States, California
NCIRE Not yet recruiting
San Francisco, California, United States, 94121
Contact: Brooke Clinical Research Coordinator    415-221-4810 ext 24495      
Principal Investigator: Steven Batki, MD         
Sponsors and Collaborators
Theranova, L.L.C.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Northern California Institute of Research and Education
Investigators
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Study Director: Michael Jaasma Theranova, L.L.C.

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Responsible Party: Theranova, L.L.C.
ClinicalTrials.gov Identifier: NCT03983317     History of Changes
Other Study ID Numbers: CRD-12-1176-01
R43AA027188-01 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Alcohol Drinking
Alcoholism
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders