NCT03983317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

June 10, 2019

Results QC Date

September 25, 2020

Last Update Submit

November 12, 2020

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline week and Week 2 of the treatment phase

  • Number of Participants With Adverse Events

    Safety assessment via device-related adverse events

    Through study completion, an average of 3 weeks

Secondary Outcomes (2)

  • Decrease in Mean Alcohol Craving Intensity

    Baseline week and Week 2 of the treatment phase

  • Usability

    Study completion, at approximately 3 weeks

Study Arms (2)

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.

Device: Empower Neuromodulation System

Interventions

Empower Neuromodulation SystemDEVICE

Transcutaneous electrical nerve stimulation

Active treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NCIRE

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Vice President of Research and Development
Organization
TheraNova, LLC
clinicalstudy@theranova.com
415-926-8616

Study Officials

  • Michael Jaasma

    Theranova, L.L.C.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: All participants will have a one-week control period with no treatment followed by two weeks of twice daily Empower treatment.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 12, 2019

Study Start

May 20, 2019

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

November 18, 2020

Results First Posted

October 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)