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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT04596267
Eligibility Criteria:
Inclusion Criteria:
1. 21-55 years of age
2. Able to verify age with a state or federal picture identification
3. Exceeds safe weekly drinking limits during the 28 days prior to consent (average of 14 drinks for women or 21 drinks for men per week)
4. Reports at least one episode of binge drinking (\>3 drinks for women, \>4 drinks for men) in the 28 days prior consent.
5. Meets DSM-5 criteria for mild alcohol use disorder or greater severity.
6. Has a smartphone to complete medication exposure period study assessments.
Exclusion Criteria:
1. Seeking treatment for alcohol problems
2. Clinical Institute Withdrawal Assessment at ≥10
3. DSM-5 diagnosis of current major depression, bipolar disorder, schizophrenia, bulimia/anorexia, dementia, insomnia disorder or a substance use disorder other than alcohol, nicotine, marijuana or caffeine
4. If female, pregnant, nursing, have plans to become pregnant
5. If female, does not agree to use an accepted form of birth control
6. Has a medical contraindication to the use of pitolisant
7. Has medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated
8. Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS)
9. BMI is greater than 40 or less than 18
10. Impaired renal function (GFR \<80 mL/min)
11. Have a history of any clinically significant renal or hepatic disease
12. Child-Pugh Score equal to or greater than Class B (evaluated based on presence or absence of encephalopathy and ascites, INR, bilirubin, and albumin) \[https://www.mdcalc.com/child-pugh-score-cirrhosis-mortality\]
13. Have a clinically significant ECG as determined by the investigator or abnormal ECG heart rate (\<45 or \>100 bpm) or QTc interval corrected for heart rate using the Fridericia formula (QTcF) \> 450 msec
14. Have a history of cardiac arrhythmias or who for other reasons are at risk for developing Torsade de Pointes including those with bradycardia, hypokalemia, and congenital QT interval prolongation
15. Has received alcohol counseling or other non-pharmacologic intervention to treat AUD in the past 90 days
16. Has taken medications that are used to treat AUD in the past 90 days
17. Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, methamphetamines, oxycontin, barbiturates, or benzodiazepines.
18. Subject is taking a medication which will significantly alter drug metabolism (e.g., strong CYP2D6 inhibitors, strong CYP3A4 inducers, or H1 receptor antagonists that cross the blood barrier (e.g. diphenhydramine or meclizine).
19. Subject is known to be a poor CYP2D6 metabolizer.
20. Subject is unable to comfortably abstain from nicotine for a period of 8 hours.
21. Has Chronic Obstructive Pulmonary Disease (COPD), history of solid organ transplant, sickle cell disease, severe heart disease or other health condition for which exposure to COVID-19 represents an unreasonable risk as determined by the study staff physician using accepted COVID-19 guidance (e.g. Centers for Disease Control, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT04596267
Study Brief:
Protocol Section:
NCT04596267