Eye-tracking test may predict which gamers benefit from naltrexone

NCT ID NCT04649892

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Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 22, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether eye-tracking patterns can predict how well naltrexone reduces symptoms of videogame disorder. Forty adults with the condition receive naltrexone and placebo in a crossover design, with eye-tracking assessments before and after each dose. The goal is to see if a simple eye test could guide personalized treatment for gaming addiction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naltrexone, an opioid receptor blocker taken orally
What this could lead to
If eye tracking can predict who responds to naltrexone, it could point toward a personalized treatment for gaming disorder.
What could go wrong
This is a small, early-phase trial with only 40 participants. Naltrexone may not reduce gaming symptoms, and eye-tracking predictions may not prove reliable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Contacts and locations

Locations

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

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

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