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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06454123
Other study ID # 2023-Oui-001
Secondary ID 1R41MH134704-01
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date June 2025

Study information

Verified date June 2024
Source Oui Therapeutics, Inc.
Contact Brian Keenaghan
Phone 2037254024
Email brian@ouitherapeutics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.


Description:

This single-arm, open-label clinical trial will test the feasibility, usability, acceptability, and preliminary efficacy of a digital therapeutic in reducing binge eating and weight in 30 adults with comorbid recurrent binge eating and obesity.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. English speaking male or female patients, 18-70 years 2. Patients with recurrent binge eating (=12 episodes in 3 months) and obesity (BMI =30) 3. Understand written and spoken English 4. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher 5. Willing and able to complete enrollment procedures 6. Able to understand the nature of the study and provide written informed consent Exclusion Criteria: 1. Patients with active psychosis 2. Patients who are acutely intoxicated at the time of enrollment 3. Currently enrolled in other treatment studies for the symptoms and behaviors targeted 4. Patients who are cognitively impaired 5. Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the digital therapeutic

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OTX-401
Evidence-based treatments for obesity and binge eating

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Oui Therapeutics, Inc. National Institute of Mental Health (NIMH)

Outcome

Type Measure Description Time frame Safety issue
Primary System Usability Sale (SUS) The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability. Week 12
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