WithdrawnNot Applicable

Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use

Stopped: Study has been placed on hold

United States0Started 2025-09

Plain-language summary

This is the first clinical trial of Endourage OMD 1200 for persons desiring to reduce their alcohol consumption.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18 years of age or older who can provide informed consent
✓. Ability to read and write in the English language and follow study-related procedures
✓. Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name.
✓. If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal)

✕. Active illicit or non-prescribed drug use
✕. Concomitant use of benzodiazepines
✕. Concomitant use of Antabuse
✕. Documented history and active treatment for seizure disorder
✕. Transaminase elevation
✕. Hepatitis C infection (currently on therapy and/or any transaminitis elevation)
✕. Hepatitis B infection (currently on therapy and/or any transaminitis elevation)
✕. Any form of mental impairment that will/could hinder safe participation in the study

Anxiety scores

Timeframe: 112 days (4-months)

Depression scores

Timeframe: 112 days (4-months)

Alcohol craving scores

Timeframe: 112 days (4-months)

NCT IDNCT04659278

SponsorEndourage, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12