Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity

Oui Therapeutics

Status: Not yet enrolling

Conditions: Binge Eating; Obesity

Treatments: Device: OTX-401

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06454123

2023-Oui-001

1R41MH134704-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: OTX-401