A Post Marketing Study to Evaluate the Safety and Efficacy of Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use

NCT04659278 NA WITHDRAWN

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

Details

Lead sponsor	Endourage, LLC
Phase	NA
Status	WITHDRAWN
Start date	2025-09
Completion	2027-01-31

Conditions

• Alcohol Drinking
• Alcohol Use, Unspecified
• Alcohol Abstinence
• Alcohol-Related Disorders

Interventions

• Endourage 1200 mg OMD ™ Oral Mucosal Drops
• Isolate
• Placebo
• Peppermint Oil, masking flavor

Primary outcomes

• Anxiety scores — 112 days (4-months)
  Generalized Anxiety Disorder (GAD-7), measure for anxiety. Baseline scores will be compared to scores at end of study across arms. Change in anxiety scores from baseline to end of study will be measured. Range from 0-4 for minimal; 5-9 mild; 10-14 moderate; 15-21 severe. Changes will be compared across arms. Increased scores will indicate that study product was not effective in decreasing symptoms measured (anxiety).
• Depression scores — 112 days (4-months)
  Patient Health Questionnaire (PHQ-9), measure for depression. Change in depression scores from baseline to end of study. Total Score for Depression Severity will be compared across arms from baseline to end of study at 112-days. Score ranges from: 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. Increased scores indicate that study product is not effective in decreasing symptoms measured (depression).
• Alcohol craving scores — 112 days (4-months)
  The Alcohol Craving Questionnaire Short Form (ACQ-SF-R) will be compared from baseline to end of study. Changes in craving score will be measured in each arm of study. Scores from 1-7 (strongly disagree to strongly agree) is measured across 12 items and 4 sub-scales (\[1\] compulsivity, \[2\] expectancy, \[3\] purposefulness, and \[4\] emotionality). The sum of the raw scores for each factor will be calculated and compared from baseline to the end of study across arms. Increased scores indicate that study product is not effective in reducing cravings for alcohol.

Countries

United States