Alcohol Use Disorder
Conditions
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.
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.
Interventions
Transcutaneous electrical nerve stimulation
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Northern California Institute of Research and Education
Theranova, L.L.C.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will have a one-week control period with no treatment followed by two weeks of twice daily Empower treatment.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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 used an investigational drug/device therapy within the past 4 weeks * Is deemed unsuitable for enrollment in the study by the PI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Number of Alcoholic Drinks Consumed Per Day | 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 | Through study completion, an average of 3 weeks | Safety assessment via device-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Mean Alcohol Craving Intensity | Baseline week and Week 2 of the treatment phase | 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. |
| Usability | Study completion, at approximately 3 weeks | 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). |
Countries
United States
Participant flow
Pre-assignment details
Participants completed the Baseline Phase first, so participants who did not complete the Baseline Phase did not start the Treatment Phase.
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment For the first week of the study, participants did not administer treatment with the Empower device. In this one-week Baseline Phase, participants only completed surveys to establish baseline values. In the final two weeks of the study, participants self-administered treatment with the Empower device two times daily. Participants completed surveys over the two-week period to evaluate the effects of the Empower treatment.
Empower Neuromodulation System: Transcutaneous electrical nerve stimulation | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 5 |
Baseline characteristics
| Characteristic | Active Treatment |
|---|---|
| Age, Continuous | 58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 2 / 25 |
Outcome results
Primary
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.
Time frame: Baseline week and Week 2 of the treatment phase
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Change in Mean Number of Alcoholic Drinks Consumed Per Day | -1.1 Change in alcoholic drinks per day | Standard Deviation 1.7 |
p-value: 0.026t-test, 2 sided
Primary
Number of Participants With Adverse Events
Safety assessment via device-related adverse events
Time frame: Through study completion, an average of 3 weeks
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment | Number of Participants With Adverse Events | 0 Participants |
Secondary
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.
Time frame: Baseline week and Week 2 of the treatment phase
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Decrease in Mean Alcohol Craving Intensity | -13 Change in units on 100-mm VAS scale | Standard Deviation 17 |
p-value: 0.001t-test, 2 sided
Secondary
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).
Time frame: Study completion, at approximately 3 weeks
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Usability | 76 Score on the SUS survey scale | Standard Deviation 15 |