Predicting Response to Naltrexone With Eye Tracking in Gaming Disorder

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Sao Paulo

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with Internet Gaming Disorder according to DSM-5

Patients with craving according to the adaptation of the Gambling Follow-up Scale (GFS) described below.

I felt an irresistible urge to play.

I felt a strong desire to play, sometimes resistable, sometimes not.

Disqualifiers

- Established contraindication to naltrexone (opioid dependence, in the process of opioid withdrawal or current use of opioid analgesics) or hypersensitivity to naltrexone;

Exposure to any other drug or experimental device in the 30 days prior to inclusion, except for occasional use of benzodiazepines;

Pregnancy, breastfeeding or patients who intend to become pregnant during the study;

Evidence of renal failure, defined as serum creatinine levels> 133 mmol / L in men and> 124 mmol / L in women, which correspond to> 1.51 mg / dl and> 1.41 mg / dl, respectively on Week 1 of inclusion;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Naltrexone group A

    Drug

    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.

  • Naltrexone

    Drug

    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.

  • Psychoeducational

    Behavioral

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

  • Eye-tracking

    Device

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 3 interventions
Group B: Group BExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adpated Internet Gaming Disorder Scale-Short Form (IGDS9-SF)

IGDS9-SF is 9 items scale in which the patient must answer how often he performs a certain behavior in the last 12 months, the score ranges from 9 to 45, patients with 21 points or more are diagnosed with Video Game Disorder according to the Brazilian validation carried out in 2020. As the IGDS9-SF is a diagnostic scale, the adaptations described below were necessary to use it to assess the response to the intervention: * Reduction of the time interval to which the scale questions refer, from 12 months to the last 12 weeks. * Adaptation of the text of each item in order to reflect the interaction with the video game and its repercussions in the last 12 weeks. To validate these changes, the investigators will perform a cross-validation with the Gambling Follow-up Scale adapted for video games described in the next item. The application of the adapted IGDS9-SF will occur at the beginning of the follow-up, before the intervention, and at the end of the intervention.

Time frame
12 Weeks.
2

Gambling Follow-Up Scale adapted to Videogames (Gaming Follow-up Scale)

The Gambling Follow-up Scale (GFS) is a self-administered scale of ten items for assessing pathological gamblers throughout treatment. For the use of GFS in this study, the third and fifth questions were excluded, which assessed the financial impact due to gambling, a rare situation in patients with Video Game Disorder (VGD). The eighth question were adapted in order to assess whether the patient had time to dedicate himself to his basic needs, a question that is more congruent to the psychopathology of VGD. And finally, the text of all the questions were adapted by exchanging the word gambling for video games. This adapted scale will be applied at the beginning of patient follow-up, before the intervention, being reapplied in 4 weeks and at the end of the intervention in the 12th week. To validate this adaptation, the investigators will do a cross-validation with the adapted IGDS9-SF scale described in the previous item.

Time frame
12 Weeks

Secondary outcomes

1

Gaming Timeline Follow-Back Method (TFB)

TFB is a retrospective interview technique designed to assess alcohol consumption. It has been used in a similar way to address other impulsive behaviors, for example, gambling. In this study it will be used to assess the patient's dedication to the video game. With this technique, the interviewer obtains information about the days and the amount of resources and time invested in the behavior. Initially, the interviewer identifies relevant dates for the patient in this period and uses them as markers that facilitate the recall of information. It helps and encourages the patient to recall, retrospectively, information about episodes of excessive gaming and write them down on a calendar sheet. Thus, a diary of the activity is obtained in the desired period.

Time frame
12 weeks
2

Short Impulsive Behavior Scale (UPPS-P)

The Short UPPS-P, like the original UPPS-P, is a Likert scale with 4 possible answers for each item (from Strongly Agree to Strongly Disagree). This scale takes the form of self-report and has 20 items, which then produce scores for the five factors of impulsivity. Each factor ranges from 4 to 16, being the lower values indicative of dysfunctionality. This brief version was successfully validated in English, successfully replicating the internal consistency and the correlations between the factors of the original scale with the benefit of saving about 66% of the time required for application.

Time frame
12 weeks
3

Social Adjustment Scale self-report version (SAS)

SAS is considered the most carefully developed social adjustment scale, showing the highest levels of reliability and validity. It is widely used and cited in the scientific literature, being useful to assess social adjustment in a wide variety of populations, both clinical and non-clinical. SAS allows an assessment of social adjustment in seven areas: work outside the home, work at home, studies, social life and leisure, relationship with family, spouse, children, home life and financial situation. It consists of 54 questions with 5 possible answers, with higher scores indicating greater impairment. In this study, it will be used to verify the effect of experimental treatment on social adjustment as a secondary outcome.

Time frame
12 weeks
4

Global Clinical Scale

The Global Clinical Scale will be used to assess global severity, considering the frequency and intensity of symptoms. It is applied by a trained person. Its score varies between 1 (normal, not sick) and 7 (extremely sick). The criterion used for improvement (positive response to treatment) is 1 = improved and 2 = greatly improved.

Time frame
12 weeks

Other outcomes

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