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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT03089320
Eligibility Criteria:
Inclusion Criteria:
* Be HIV-infected.
* Recent significant alcohol consumption as determined by a PEth greater than 20 ng/ml.
* Able to provide informed consent.
* Meet any of the following criteria for unhealthy alcohol use:
* At-risk Drinking - greater than 14 drinks per week or greater than 4 drinks per occasion in men and greater than 7 drinks per week or greater than 3 drinks per occasion in women and those over 65.161
* Medical condition impacted by alcohol as evidenced by one of the following: 1) detectable HIV viral load (\>200 copies/ml),) tobacco use disorder and smoking more than 5 cigarettes per day, 3) detectable HCV virus, 4) liver fibrosis with a FIB-4 \>1.45) Patient Health Questionnaire (PHQ-9, validated measure for depression) score greater than 9, or 6) current (at least 30 day supply in the past 60 days) prescription for a psychoactive medication that interacts with alcohol-including benzodiazepines, opioids, antipsychotics, antidepressants, sleeping medications and muscle relaxants.
* Alcohol Use Disorder - Meet DSM-5 criteria for alcohol use disorder, not in remission
Exclusion Criteria:
No subject may:
* Be acutely suicidal, or with a psychiatric condition that affects his/her ability to provide informed consent or participate in counseling interventions (e.g. psychotic, dementia, delusional).
* Be currently enrolled in formal treatment for alcohol (excluding mutual-help, e.g. Alcoholics Anonymous)
* Have medical conditions that would preclude completing or be of harm during the course of the study.
* Be a pregnant or nursing woman or women who do not agree to use a reliable form of birth control.
* Have a current diagnosis of or be in remission for a gambling disorder given the gaming nature of CM.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03089320
Study Brief:
Protocol Section:
NCT03089320