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

NCT ID: NCT06454123

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Binge Eating Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

OTX-401

Intervention Type DEVICE

Evidence-based treatments for obesity and binge eating

Interventions

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OTX-401

Evidence-based treatments for obesity and binge eating

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Oui Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Brian Keenaghan

Role: CONTACT

2037254024

Other Identifiers

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1R41MH134704-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-Oui-001

Identifier Type: -

Identifier Source: org_study_id

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