Alcohol Use DisorderNCT03983317
Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
A study testing Empower Neuromodulation System in people with Alcohol Use Disorder, run by Theranova, L.L.C. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Empower Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 26 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 used an investigational drug/device therapy within the past 4 weeks
- Is deemed unsuitable for enrollment in the study by the PI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Empower Neuromodulation System
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empower Neuromodulation SystemDevice
Transcutaneous electrical nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | 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. |
| Active treatment | Experimental | 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. Receives: Device: Empower Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Number of Alcoholic Drinks Consumed Per Day
Change in the self-reported average daily consumption over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Measured: Baseline week and Week 2 of the treatment phase
Number of Participants With Adverse Events
Safety assessment via device-related adverse events
Measured: Through study completion, an average of 3 weeks
Secondary outcomes (2)
Decrease in Mean Alcohol Craving Intensity
Change in self-reported average 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). We compared the average daily craving intensity over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Measured: Baseline week and Week 2 of the treatment phase
Usability
System Usability Scale (SUS) survey to evaluate usability. The SUS is a 10-item self-report survey (each question is answered on a 5-point Likert scale) which measures usability. An SUS score of 68 is considered average, whereas SUS=80 is the 90th percentile score ("excellent").
Measured: Study completion, at approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start20 May 2019
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Northern California Institute of Research and Education
- Responsible party
- Sponsor
- Investigators
- Michael Jaasma, Study director, Theranova, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983317
- Sponsor's protocol ID
- CRD-12-1176-01
- Other IDs
- R43AA027188-01
- Status last verified
- Nov 2020
- First submitted
- 10 Jun 2019
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients
- ClinicalTrials.gov ID
- NCT03983317
- Acronym / sponsor ID
- CRD-12-1176-01
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Northern California Institute of Research and Education
- Study start
- 20 May 2019 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will have a one-week control period with no treatment followed by two weeks of twice daily Empower treatment.
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –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. |
| Active treatment | Experimental | Device: Empower Neuromodulation SystemParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empower Neuromodulation SystemTranscutaneous electrical nerve stimulation | Device | Active treatment |
Primary outcome
Change in Mean Number of Alcoholic Drinks Consumed Per Day
Time frame: Baseline week and Week 2 of the treatment phase
Change in the self-reported average daily consumption over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Number of Participants With Adverse Events
Time frame: Through study completion, an average of 3 weeks
Safety assessment via device-related adverse events
2 secondary outcomes
Decrease in Mean Alcohol Craving Intensity
Time frame: Baseline week and Week 2 of the treatment phase
Usability
Time frame: Study completion, at approximately 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Jaasma study director
Theranova, L.L.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empower Neuromodulation System in people with Alcohol Use Disorder, run by Theranova, L.L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Number of Alcoholic Drinks Consumed Per Day (time frame: Baseline week and Week 2 of the treatment phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.