RecruitingPhase 2NCT04649892

Predicting Response to Naltrexone With Eye Tracking in Gaming Disorder

Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder


Sponsor

University of Sao Paulo

Enrollment

40 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Eye-tracking, a drug called Naltrexone, and others for people with gaming disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNaltrexone group A

The patient undergoes an initial admission assessment, including an eye-tracking pattern analysis. During weeks 1 and 2, the patient starts naltrexone 50 mg orally once daily, with a new eye-tracking assessment 1 hour after the first dose. During weeks 3 and 4, an eye-tracking assessment is performed, the medication is switched to oral placebo once daily in the morning, and the assessment is repeated 1 hour after the first dose. During weeks 5 and 6 (washout), a new eye-tracking assessment is conducted and the placebo is maintained once daily. Finally, during weeks 7 to 12 (maintenance), the placebo is replaced by naltrexone 50 mg orally once daily in the morning for 6 weeks, with eye-tracking assessments performed every two weeks.

DRUGNaltrexone

The patient undergoes an initial admission assessment, including an eye-tracking pattern analysis. During weeks 1 and 2, the patient starts placebo orally once daily, with a new eye-tracking assessment 1 hour after the first dose. During weeks 3 and 4, an eye-tracking assessment is performed, the medication is switched to naltrexone 50 mg orally once daily in the morning, and the assessment is repeated 1 hour after the first dose. During weeks 5 and 6 (washout), a new eye-tracking assessment is conducted and the medication is switched back to placebo once daily in the morning. Finally, during weeks 7 to 12 (maintenance), the placebo is replaced by naltrexone 50 mg orally once daily in the morning for 6 weeks, with eye-tracking assessments performed every two weeks.

BEHAVIORALPsychoeducational

Participants will also attend to 4 sessions of psychoeducational intervention in weeks 2, 4, 6, and 8

DEVICEEye-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.


Locations(1)

Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

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NCT04649892


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