Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder

NCT04649892 | Unknown Phase 2 DMC

• 1 other identifier: Gaming Naltrexone Eye Tracking
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Videogame disorder; Gaming disorder; eye tracking; naltrexone; problematic videogame users

Outcome Measures

Primary Outcomes (2)

• 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.

  12 Weeks.

• 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.

  12 Weeks

Secondary Outcomes (10)

• Gaming Timeline Follow-Back Method (TFB)

  12 weeks

• Short Impulsive Behavior Scale (UPPS-P)

  12 weeks

• Social Adjustment Scale self-report version (SAS)

  12 weeks

• Global Clinical Scale

  12 weeks

• Rotter's Locus of Control Scale

  12 weeks

Study Arms (2)

Naltrexone

EXPERIMENTAL

A 12 week Naltrexone flexible dose administration plus 4 sessions of a psychoeducational intervention and 4 eye-tracking sessions

Drug: Naltrexone; Behavioral: Psychoeducational; Device: Eye-tracking

Placebo

PLACEBO COMPARATOR

A 12 week placebo matching tablets plus 4 sessions of a psychoeducational intervention and 4 eye-tracking sessions

Drug: Placebo; Behavioral: Psychoeducational; Device: Eye-tracking

Interventions

Naltrexone DRUG

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

Also known as: Active drug

Naltrexone

Placebo DRUG

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.

Also known as: Inactive drug

Placebo

Psychoeducational BEHAVIORAL

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

Naltrexone; Placebo

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.

Also known as: Tobii eye-tracker

Naltrexone; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be evaluated initially in a clinical interview by a specialized psychiatrist and then by a second interviewer who will use a semi-structured interview to check the DSM-5 criteria for Video Game Disorder (VGD) modeled in the standard format of Schedules for clinical assessment in neuropsychiatry (SCID). Only a specific subgroup of VGD will be included in our sample, which will be called VGDa, a sample that represent a framework of behavioral dependence in essence. Patients in this sample must necessarily have the following symptoms: salience, withdrawal, relapse, conflict, mood modification and fissure. The criteria to delimit this subgroup are listed below:
• Patients diagnosed with Internet Gaming Disorder according to DSM-5
• Patients who have a score of 4 or higher on the following questions on the IGDS9-SF scale (Internet Gaming Disorder Scale 9 - Short Form):
• Question 1: Salience assessment. Question 2: Abstinence assessment. Question 4: Relapse assessment. Question 6: Conflict assessment. Question 8: Mood modification assessment.
• Patients with craving according to the adaptation of the Gambling Follow-up Scale (GFS) described below.
• An adaptation of the GFS scale, originally used to evaluate patients with Gambling Disorder, was made in order to allow the evaluation of the craving symptom in a patient with VGD. It will only be used the fourth question on this scale as follows.
• "4) In the past 4 weeks, how was your desire to play?
• I felt an irresistible urge to play.
• I felt a strong desire to play, sometimes resistable, sometimes not.
• I felt a strong desire to play, but resistable most of the time.
• I felt a slight desire to play.
• I didn't feel like playing. " It will considered that the patient has craving if he answers this question by selecting items 1, 2 or 3.
• Patients must meet the following criteria before randomization:
• Have read and signed the informed consent form after the nature of the study has been fully explained and before carrying out any procedures related to the study;
• Age between 18 and 60 years old, inclusive;

You may not qualify if:

• \- Established contraindication to naltrexone (opioid dependence, in the process of opioid withdrawal or current use of opioid analgesics) or hypersensitivity to naltrexone;
• Pregnancy, breastfeeding or patients who intend to become pregnant during the study;
• Significant cardiovascular disease, including a history of myocardial infarction in the last 5 years, stroke, clinically significant heart valve disease, unstable angina, clinically abnormal ECG, arrhythmia or congestive heart failure, determining functional class III or IV (NYHA, 1964);
• Uncontrolled hypertension (defined as a diastolic blood pressure of 100 mm / Hg and / or a systolic blood pressure of 180 mm / Hg with or without medication). Hypertensive patients receiving medication should be receiving the same dose of the same antihypertensive medication for at least two months;
• History or current comorbidity with bipolar affective disorder, obsessive compulsive disorder, psychotic disorder, schizophrenia or severe depression, additionally verified through the Patient Health Questionnaire 9 (PQH-9\> 19), current suicide risk, or any other neuropsychiatric condition in severe cognitive impairment;
• Current or previous history (in the previous two years) of abuse / dependence on alcohol or other psychoactive substance (except nicotine);
• If at any moment the clinician responsible for the patient identifies suicidal ideation with risk of self-harm, or death;
• Clinically significant hematological or immunological disorder;
• Patients currently receiving psychotropic medications, except for the episodic use of benzodiazepines;
• Illiteracy, or any other condition that prevents the reading and understanding of the research instruments;
• Do not have a telephone line available for remote monitoring;
• Living alone, or not being able to present a family member capable of providing collateral information on gaming behavior;
• To be followed up in another therapeutic program.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

São Paulo, 05403-000, Brazil

Location

Related Links

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MeSH Terms

Interventions

Naltrexone; Bulk Drugs; Eye-Tracking Technology

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pharmaceutical Preparations; Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Hermano Tavares

  Associate

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Richard Clorado de Sa, Psychiatrist

CONTACT

+55-11-964163663; rafael8richard@gmail.com

Hermano Tavares, Professor

CONTACT

+55-11-26617805; hermanot@uol.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly allocated to two groups: 1. Naltrexone and brief psychoeducational intervention 2. Placebo and brief psychoeducational intervention This will be double-blind controlled study.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)