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 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT07040592
Eligibility Criteria:
Inclusion Criteria:
* diagnosed with HIV
* Receive care at the Atlanta VA Healthcare System
* Age 18 or over
* Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen
* Have evidence of significant alcohol use: PEth \> 20ng/ml
* Prescribed \>=5 medications
* Have cell phone or reliable contact number
* Can provide written informed consent
Exclusion Criteria:
* Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
* Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
* Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment)
* Untreated moderate to severe opioid use disorder
* Residence out of state
* Inability to read or understand English
* History of serious hypersensitivity or adverse reaction to study medication
* Taking potentially interactive medication(s) for diabetes
* BMI\<23
* Diagnosis of type 1 Diabetes
* Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, Severe gastrointestinal dysmotility, including gastroparesis, History of pancreatitis (does not pertain to patients for whom the cause of pancreatitis is known and no longer presents a risk), severe gallbladder disease
* Known Proliferative Diabetic Retinopathy, severe Non-Proliferative Diabetic Retinopathy, clinically significant Macular Edema, or Cystoid Macular Edema
* Already prescribed the pilot medication at the time of study recruitment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT07040592
Study Brief:
Protocol Section:
NCT07040592