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Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder

NCT04649892 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-12-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Hermano Tavares · Associate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04649892 on ClinicalTrials.gov