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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
35
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.
University of California, San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
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
Time frame: 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
Time frame: Week 12
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.
Time frame: Week 12
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
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12