Predicting Response to Naltrexone With Eye Tracking in Gaming Disorder

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

Conditions

• Gaming Disorder

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.

Sponsors & Collaborators

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Hermano Tavares · Associate

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2026-12-31

Completion

2027-07-31

Countries

• Brazil

Study Locations