Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multi-site, double-blinded, prospective, randomized, sham-controlled study
To evaluate the safety and effectiveness of the Empower Neuromodulation System in alcohol use disorder (AUD) patients. The primary safety endpoint will be device-related serious adverse events. The primary effectiveness endpoint will be responder rate at 12 weeks, where a responder is defined as a subject who experiences at least a one level reduction in the WHO risk level for daily alcohol consumption from Baseline to Week 12 as measured via the 28-day Timeline Follow-back (TLFB). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Active Comparator | The Active Treatment will use a functional Stimulator system. |
|
| Sham Treatment | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empower Neuromodulation System | Device | The Empower Neuromodulation System is designed to provide transcutaneous stimulation to the branches of a spinal nerve. The system comprised of three key components: (A) The Stimulator, (B) the Empower smartphone app, and (C) the Gel Patch. The smartphone application is used to coordinate treatment and record participant responses. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint: Frequency of device-related Serious AEs (SAEs) | The primary safety endpoint will be comparing the frequency of device-related Serious AEs (SAEs) between the Active and Sham Treatment groups, where device-related SAEs include probably and possibly device-related serious adverse events | Week 12 |
| Primary Effectiveness Endpoint: Change in WHO risk level via 28-day TLFB | The primary effectiveness endpoint is the responder rate at Week 12, where a responder is a study subject who experiences ≥1 level reduction in the WHO risk level from Baseline to Week 12 via the 28-day Timeline Follow-back (TLFB), and responder rate is the percentage of participants in a treatment group who are responders | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alcohol Craving Intensity via the Penn Alcohol Craving Survey (PACS) | Change in alcohol craving intensity. The change in alcohol craving intensity as assessed via the Penn Alcohol Craving Survey (PACS) from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. The scale has a range of 0-30 where a higher score indicates more severe cravings. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Effectiveness - Responder Rate Week 6 | Responder rate at Week 6. The percentage of responders at 6 weeks will be compared between the Active and Sham Treatment groups. | Week 6 |
| Exploratory Effectiveness - Drink reduction Week 12 via TLFB |
Inclusion Criteria:
A candidate for this study must meet ALL of the following inclusion criteria:
Exclusion Criteria:
A candidate will be excluded from the study if ANY of the following conditions are met:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| KT Venkateswara-Rao, PhD | TheraNova, LLC | Principal Investigator |
| David Pennington, PhD | Northern California Institute of Research and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Yale University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Multi-center, double-blinded, prospective, randomized, sham-controlled study
Not provided
Not provided
Site staff are blinded to the subject's assigned Arm.
|
| Change in Heavy Drinking Days (HDD) via 28-day TLFB | Change in heavy drinking days (HDD). The change in HDD as assessed via the 28-day Timeline Follow-Back (TLFB) from Baseline to Week 12 will be compared between the Active and Sham Treatment groups, where a HDD is defined as 5 or more drinks for men and 4 or more drinks for women in one calendar day | Week 12 |
| Change in Alcohol Related Problems via SIP | Change in alcohol-related problems. The change in alcohol-related problems as assessed via the Short Index of Problems (SIP) from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. The total score has a range of 0-15 where a higher total indicates more problems. | Week 12 |
| Change in Alcohol Consumption via PEth analysis | Change in phosphatidylethanol (PEth)-based evaluation of alcohol consumption. The change in alcohol consumption as assessed via PEth analysis from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. | Week 12 |
| Change in Alcohol Craving Intensity via daily self reports | Change in daily alcohol craving intensity. The change in daily alcohol craving intensity as assessed via daily self-reports on the Empower app (100-point Visual Analog Scale (VAS)) from Week 1 to Week 12 will be compared between the Active and Sham Treatment groups. The scale range is 0-100, where the higher rating indicates higher level of alcohol cravings. | Week 12 |
| Improvement in Clinician Assessment of Illness via CGI | Improvement in clinician assessment of illness. The clinician assessment of improvement in illness as assessed via Clinical Global Impression (CGI) at Week 12 will be compared between the Active and Sham Treatment groups. | Week 12 |
Change in alcoholic drinks consumed at Week 12. The change in average alcoholic drinks consumed per day as assessed via the 28-day TLFB from Baseline to Week 12 will be compared between the Active and Sham Treatment groups.
| Week 12 |
| Exploratory Effectiveness - % Drink change Week 12 via TLFB | Percent reduction in alcoholic drinks consumed at Week 12. The percent change in average alcoholic drinks consumed per day as assessed via the 28-day TLFB from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. | Week 12 |
| Exploratory Effectiveness - Drinks change at Week 6 | Change in alcoholic drinks consumed at Week 6. The change in average alcoholic drinks consumed per day as assessed via the 28-day TLFB from Baseline to Week 6 will be compared between the Active and Sham Treatment groups. | Week 6 |
| Exploratory Effectiveness - Drink change Week 12 via App | Change in alcoholic drinks consumed at Week 12. The change in average alcoholic drinks consumed per day as assessed via the daily self-reports on the Empower app from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. | Week 12 |
| Exploratory Effectiveness - % Drink change Week 12 via App | Percent change in alcoholic drinks consumed at Week 12. The percent change in average alcoholic drinks consumed per day as assessed via the daily self-reports on the Empower app from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. | Week 12 |
| Exploratory Effectiveness - Drink change Week 6 via App | Change in alcoholic drinks consumed at Week 6. The change in average alcoholic drinks consumed per day as assessed via the daily self-reports on the Empower app from Baseline to Week 6 will be compared between the Active and Sham Treatment groups. | Week 6 |
| Exploratory Effectiveness - Change in HDD at Week 6 via TLFB | Change in HDD at Week 6. The change in HDD as assessed via the 28-day TLFB from Baseline to Week 6 will be compared between the Active and Sham Treatment groups. | Week 6 |
| Exploratory Effectiveness - Abstinence at Week 12 via TLFB | Abstinence at Week 12. The percent of subjects who are abstinent at Week 12 as assessed via the 28-day TLFB at Week 12 will be compared between the Active and Sham Treatment groups. | Week 12 |
| Exploratory Effectiveness - Alcohol consumption at Week 6 via PEth | Change in PEth-based evaluation of alcohol consumption at Week 6. The change in alcohol consumption as assessed via PEth analysis from Baseline to Week 6 will be compared between the Active and Sham Treatment groups. | Week 6 |
| Exploratory Effectiveness - Alcohol craving reduction at Week 6 via PACS | Change in alcohol craving intensity at Week 6. The change in alcohol craving intensity as assessed via the Penn Alcohol Craving Scale (PACS) from Baseline to Week 6 will be compared between the Active and Sham Treatment groups. The scale has a range of 0-30 where a higher score indicates more severe cravings. | Week 6 |
| Exploratory Effectiveness - Alcohol craving at Week 12 via PACS | Percent change in alcohol craving intensity at Week 12. The percent change in alcohol craving intensity as assessed via the PACS from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. The scale has a range of 0-30 where a higher score indicates more severe cravings. | Week 12 |
| Exploratory Effectiveness - Alcohol craving change at Week 6 via VAS | Change in daily alcohol craving intensity at Week 6. The change in daily alcohol craving intensity as assessed via daily self-reports on the Empower app (100-point Visual Analog Scale (VAS)) from Week 1 to Week 6 will be compared between the Active and Sham Treatment groups. For each subject, the average craving score per day will be calculated for each study week from the daily surveys, and the average score for Week 1 will be compared against the average score for Week 6. The scale range is 0-100, where the higher rating indicates higher level of alcohol cravings. | Week 6 |
| Exploratory Effectiveness - Alcohol craving % change at Week 12 via VAS | Percent reduction in daily alcohol craving intensity at Week 12. The percent change in daily alcohol craving intensity as assessed via daily self-reports on the Empower app (100-point Visual Analog Scale (VAS)) from Week 1 to Week 12 will be compared between the Active and Sham Treatment groups. For each subject, the average craving score per day will be calculated for each study week from the daily surveys. The scale range is 0-100, where the higher rating indicates higher level of alcohol cravings. | Week 12 |
| Exploratory Effectiveness - Change in alcohol-related problems at Week 6 via SIP | Change in alcohol-related problems at Week 6. The change in alcohol-related problems as assessed via the SIP from Baseline to Week 6 will be compared between the Active and Sham Treatment groups. The total score has a range of 0-15 where a higher total indicates more problems. | Week 6 |
| Exploratory Effectiveness - Change in anxiety at Week 12 via BAI | Change in anxiety at Week 12. The change in anxiety as assessed via the Beck Anxiety Inventory (BAI) from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. The total score has a range of 0-63 where a higher total indicates more severe anxiety. | Week 12 |
| Exploratory Effectiveness - Change in depression at Week 12 via PHQ-9 | Change in depression at Week 12. The change in depression as assessed via the Patient Health Questionnaire (PHQ-9) from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. The questionnaire scoring ranges from 0-27 where the higher number indicates higher level of depression. | Week 12 |
| Exploratory Effectiveness - Satisfaction with treatment at Week 12 via VAS | Satisfaction with treatment. Satisfaction with treatment as assessed via 100-mm Visual Analog Scale (VAS) at Week 12 will be compared between the Active and Sham Treatment groups. The scale range is 0-100, where the higher rating indicates higher level of satisfaction with the device and phone app. | Week 12 |
| Exploratory Effectiveness - System Usability at Week 12 via SUS | Usability. System usability as assessed via the SUS at Week 12 will be compared between the Active and Sham Treatment groups. Scores from the Active Treatment group will also be compared against benchmarks for average score (SUS=68) and excellent score (SUS=80). | Week 12 |
| New Haven |
| Connecticut |
| 06516 |
| United States |