NCT04649892

Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

It is a double blind controlled study to test the hypothesis that it's possible to predict the response to naltrexone in Videogame Disorder with the use of Eye Tracking device, during a period of 12 weeks

Detailed description

This will be a double blind controlled study in which the investigators will select a specific sample of individuals diagnosed with a video game disorder representing a picture of genuine dependence on this technology. The sample will be submitted to the use of naltrexone over a period of 12 weeks and it wiil be assessed whether there was a response to this intervention and whether that response can be predicted through attentional bias analysis using the Eye Tracking device.

Conditions

• Gaming Disorder

Interventions

Type	Name	Description
DRUG	Naltrexone	Patients will receive daily doses of Naltrexone, starting at 50mg and increasing 25mg per week until reaching 200mg or the maximum tolerated by the patient
DRUG	Placebo	Patients will receive daily doses placebo matching tablets for the 12 weeks of the study. Throughout this period, possible adverse effects will be monitored weekly.
BEHAVIORAL	Psychoeducational	Participants will also attend to 4 sessions of psychoeducational intervention in weeks 2, 4, 6, and 8
DEVICE	Eye-tracking	The attentional bias of the participants will be assessed using the Eye-tracking device in 4 moments throughout the study: * Before taking the first dose of naltrexone or placebo. * One hour after taking the first dose of naltrexone or placebo. * One week after continuous and daily use of naltrexone or placebo. * At the end of the intervention, after 12 weeks of continuous and daily use of naltrexone or placebo.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-12-02
• Last updated: 2020-12-22

Locations

1 site across 1 country: Brazil