Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder

December 19, 2020 updated by: Hermano Tavares, University of Sao Paulo
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a double blind controlled study in which the investigators will select a specific sample of individuals diagnosed with a video game disorder representing a picture of genuine dependence on this technology. The sample will be submitted to the use of naltrexone over a period of 12 weeks and it wiil be assessed whether there was a response to this intervention and whether that response can be predicted through attentional bias analysis using the Eye Tracking device.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-000
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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?

  1. I felt an irresistible urge to play.
  2. I felt a strong desire to play, sometimes resistable, sometimes not.
  3. I felt a strong desire to play, but resistable most of the time.
  4. I felt a slight desire to play.
  5. 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;

  • Female patients must be:

    1. In post-menopause for at least one year, or;
    2. Being surgically incapable of becoming pregnant (undergoing bilateral hysterectomy or oophorectomy or tubal ligation or otherwise being unable to become pregnant), or;
    3. Be practicing an acceptable method of birth control (defined as: hormonal contraceptives, spermicide plus barrier, a single vasectomized partner and / or intrauterine device).
    4. If a patient with the potential to become pregnant is practicing an acceptable method of birth control (as mentioned above), she must have a negative urine pregnancy test at the enrollment stage, as well as, at baseline, before receiving the study drug.

Exclusion Criteria:

  • - 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;
  • Evidence of clinically significant liver failure (defined as AST or ALT> 2 times the upper limit of normal) in Week 1 of inclusion;
  • 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;
  • Evidence of uncontrolled thyroid disorders, including hyper or hypothyroidism or abnormal TSH level. Patients who are known to have thyroid hormone replacement need to have had a stable dose for at least three months prior to inclusion and a normal TSH level upon inclusion
  • 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.

The Mini International Neuropsychiatric Interview (MINI) will be used to verify the psychiatric exclusion diagnoses. This is a structured diagnostic interview, with quick application - approximately 45 minutes - compatible with the DSM-IV criteria. Its objective is the verification and standardization of the main Psychiatric Disorders of Axis 1 of DSM IV. It is performed by clinicians after rapid training (1 to 3 hours). The translated and adapted Brazilian version showed globally satisfactory reliability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Naltrexone
A 12 week Naltrexone flexible dose administration plus 4 sessions of a psychoeducational intervention and 4 eye-tracking sessions
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
Other Names:
  • Active drug
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.
Other Names:
  • Tobii eye-tracker
PLACEBO_COMPARATOR: Placebo
A 12 week placebo matching tablets plus 4 sessions of a psychoeducational intervention and 4 eye-tracking sessions
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.
Other Names:
  • Tobii eye-tracker
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.
Other Names:
  • Inactive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adpated Internet Gaming Disorder Scale-Short Form (IGDS9-SF)
Time Frame: 12 Weeks.

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)
Time Frame: 12 Weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gaming Timeline Follow-Back Method (TFB)
Time Frame: 12 weeks

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.
12 weeks
Short Impulsive Behavior Scale (UPPS-P)
Time Frame: 12 weeks
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.
12 weeks
Social Adjustment Scale self-report version (SAS)
Time Frame: 12 weeks
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.
12 weeks
Global Clinical Scale
Time Frame: 12 weeks
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.
12 weeks
Rotter's Locus of Control Scale
Time Frame: 12 weeks
The prediction analysis in this study will be based on individual variation characteristics, more specifically on the internal-external control locus trait, for this the Rotter scale translated and adapted to Brazilian Portuguese will be used. It consists of 29 questions with 2 possible answers, with higher scores indicating External Locus of Control and lower scores indicating Internal Locus of Control
12 weeks
Eye tracking
Time Frame: 12 weeks

The purpose of this intervention is to carry out assessments of the visual tracking patterns and verify their correlation with the clinical response of the individuals who underwent the intervention.

The slide shows projected in the test will consist of neutral and video game related images. Each attempt will contain two images (video games and neutrals) and will last for 8 seconds, with 25 attempts in total. Each of the four eye tracking sessions will contain an exclusive slide show (that is, new images each time) and the order of presentation will be random. The dependent variables that will be measured will include: total number of fixations, average length of stay and duration of the first fixation in a video game figure.
12 weeks
Mini International Neuropsychiatric Interview (MINI)
Time Frame: 12 weeks
Compared with several reference criteria, in different contexts (psychiatric units and primary care centers), this structured diagnostic interview showed psychometric qualities similar to more complex standardized diagnostic interviews and allows a reduction of at least 50% in the evaluation time, with duration 15 to 30 minutes. It will be used in this study to describe and control DSM-IV Axis 1 psychiatric disorders. MINI has a translated and adapted version for Brazil and will be used in this study to control psychiatric comorbidities.
12 weeks
PHQ-9 Patient Health Questionnaire
Time Frame: 12 weeks

PHQ-9 is one of the most studied psychometric assessment tools for assessing depression in medicine. It is part of a more comprehensive and entirely self-administered test, the PHQ, developed with the aim of screening for frequent mental disorders in the context of primary care such as depression, alcohol use anxiety, somatoform disorders and eating disorders.

PHQ-9 consists of nine questions, which correspond to the DSM-5's nine diagnostic criteria for depression. Each item receives a score from 0 to 3, indicating the frequency of the presence of symptoms in the last two weeks. The total score ranges from 0 to 27 and represents the sum of the responses of the nine items.
12 weeks
Beck Anxiety Inventory (BAI)
Time Frame: 12 weeks

The Beck Anxiety Inventory is a self-administered scale composed of 21 questions that measure the intensity of anxiety symptoms in the last week (0 = absent to 3 = severe) through descriptive statements and does not aim at diagnostic aspects. The proposed cut-off note for the Portuguese version, in samples from psychiatric patients, suggests:

<10 = minimum; 10-19 = light 20-30 = moderate; 31-63 = severe. This scale will be used in this study to control the associated anxious symptoms.
12 weeks
Ugvalg for Kliniske Undersgelser (UKU) scale of side effects
Time Frame: 12 weeks
The UKU is a detailed scale for assessing drug side effects comprising the following 4 groups of psychic, neurological, autonomic and other side effects. Each item is evaluated on a scale from zero (absent) to 3 (severe). For each item, the causal relationship with the medication in use (unlikely, possible and probable) is marked. There is also an item of global assessment of the interference of side effects on the patient's daily performance (0 = no side effects, 3 = side effects markedly interfering with performance). There is also another item that assesses the consequence of interference: from 0 = no action to 3 = discontinuation of medication.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Hermano Tavares, Associate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (ACTUAL)

December 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 19, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gaming Naltrexone Eye Tracking

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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