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RECRUITING
NCT04649892
PHASE2

Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder

Sponsor: University of Sao Paulo

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-07-01

Completion Date

2027-07

Last Updated

2026-07-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Naltrexone 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.

DRUG

Naltrexone

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.

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.

Locations (1)

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

São Paulo, São Paulo, Brazil