RCT for Gambling and Naltrexone, Using Use Eye-tracking Analysis to Predict Treatment Response

NCT04738773 | Unknown Phase 2

• 1 other identifier: Gambling Natrexone ET
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to determine whether favorable response to naltrexone orally taken in treatment of GD can be predicted by patterns of visual scanning, assessed by eye-tracking technology before, at the start and throughout gambling treatment with naltrexone.

Conditions

Eye Tracking; Gambling Disorder; Naltrexone

Outcome Measures

Primary Outcomes (1)

• Gambling Follow up scale (GFS)

  Day 0 and day 84

Secondary Outcomes (6)

• Gambling Self-Assessment Scale (G-SAS)

  Day 0 and day 84

• Gamblers´ Beliefs Questionnaires (GBQ)

  Day 0 and day 84

• Timeline Follow-Back Method, (TFB)

  Day 0 and day 84

• Barratt Impulsiveness Scale, version 11

  Day 0 and day 84

• Social Adjustment Scale self-report version

  Day 0 and day 84

Other Outcomes (2)

• Locus of control scale internal- external

  Day 0,day 7, and day 84

• Eye Tracking

  Day 0, day 7 and day 84

Study Arms (2)

Patients receiving Naltrexone

ACTIVE COMPARATOR

Drug: Naltrexone

Patients receiving Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Naltrexone DRUG

On the active drug group, naltrexone will be prescribed on flexible dose mode, receiving 50mg per day on the first week, with an increase of 25mg each week until a maximum of 200 mg per day or as much as tolerated by the patient.

Patients receiving Naltrexone

Placebo DRUG

Placebo

Patients receiving Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and woman aged 21 to 60 years;
• Female patients should be:
• postmenopausal for at least one year, or;
• are surgically unable to become pregnant (undergoing bilateral hysterectomy or oophorectomy or tubal ligation or otherwise unable to become pregnant), or;
• be practicing an acceptable method of birth control (defined as hormonal contraceptives, spermicide plus barrier, a single vasectomized partner and / or intrauterine device);
• Have read and signed the informed consent form.

You may not qualify if:

• \. Hypersensitivity to naltrexone or contraindication of naltrexone use; 2. Exposure to another pharmacological drug in the last 30 days; 3. Pregnancy or lactation; 4. Kidney dysfunction: Creatine serum \> 133 mmol/L in men \> 124 mmol/L in women, which correspond \> 1,51 mg/dL e \> 1,41 mg/Dl; 5. Liver dysfunction (aspartate transaminase (AST) and alanine transaminase (ALT) \> 2times the upper limit of normal; 6. Cardiovascular disease, hypertension; 7. Lifetime history of bipolar disorder, Obsessive compulsive disorder, schizophrenia or any psychotic disorder, or depression (BDI\> 30 points), clinically significant suicidality; 8. Lifetime history of drug (except nicotine) or alcohol; 9. Hematologic or immunologic dysfunction; 10. Subjects receiving psychoactive drugs, except sporadic use of benzodiazepines; 11. Simultaneous participation in other GD-related; 12. Lack of reliable contact information; 13. Illiteracy of other condition that difficult reading and understanding the study questionnaires and orientations; 14. Not having a cellphone line;

Sponsors & Collaborators

• University of Sao Paulo: lead

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MeSH Terms

Conditions

Gambling

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

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

Central Study Contacts

Hermano Tavares

CONTACT

55-11-26617805; hermanoqt@gmail.com

Rache Takahashi

CONTACT

55 11 99517953; chel_est89@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 4, 2021
• Study Start: June 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 4, 2021

Record last verified: 2021-01