Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT03582150
Eligibility Criteria:
Inclusion Criteria:
* Male or female Subject between the ages of 21-75 years old
* Meeting DSM-V criteria for alcohol use disorder and needing medically supervised detoxification based on medical history and pattern of alcohol use delineated by timeline follow back method.
* Has 24/7 easy access to a hospital. This is to ensure easy admission to a higher level of care if indicated.
* Willing to use the Soberlink Device to provide blood alcohol concentration (BAC)
* Willing to use the blood pressure cuff to provide blood pressure and pulse (BPPT) measurement
* Willing to sign an informed consent
Exclusion Criteria:
* BAC above the legal driving limit at the time of screening
* Developing symptoms or history of symptoms of severe withdrawal syndrome such as fever, disorientation, drenching sweats, severe tachycardia, or severe hypertension
* History of delirium tremens or seizures
* Co-morbid medical or psychiatric history requiring inpatient admission for careful monitoring
* Subject unwilling to respond to redirection when blood pressure and heart rate warning signs are triggered
* Does not have an iPhone, iPod, iPad, or Apple Watch with iOS 7.0 or later, or does not have an Android phone or tablet with Android 4.4 or later
* Unable or unwilling to properly use the monitoring devices, or find the monitoring devices an obstruction to comply with treatment
* Subject that is non-English speaking
* Subject that is a child, adolescent, or cognitively impaired
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT03582150
Study Brief:
Protocol Section:
NCT03582150