RCT for Gambling and Naltrexone, Using Use Eye-tracking Analysis to Predict Treatment Response
Primary Purpose
Eye Tracking, Gambling Disorder, Naltrexone
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Eye Tracking
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria are:
- 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.
Exclusion Criteria:
- 1. 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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Patients receiving Naltrexone
Patients receiving Placebo
Arm Description
Outcomes
Primary Outcome Measures
Gambling Follow up scale (GFS)
Secondary Outcome Measures
Gambling Self-Assessment Scale (G-SAS)
Gamblers´ Beliefs Questionnaires (GBQ)
Timeline Follow-Back Method, (TFB)
Barratt Impulsiveness Scale, version 11
Social Adjustment Scale self-report version
Clinical Global Impression (CGI)
Full Information
NCT ID
NCT04738773
First Posted
January 31, 2021
Last Updated
February 3, 2021
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04738773
Brief Title
RCT for Gambling and Naltrexone, Using Use Eye-tracking Analysis to Predict Treatment Response
Official Title
Double Blind 12-week Controlled Experiment With Two Groups of Pathological Gamblers, One Taking Active Drug (Naltrexone) and the Other Receiving Placebo.Patters Patterns of Visual Tracking Will be Acessed on Both Groups Prior and During Tratment in Order to Predict Treatment Response
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
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
5. Study Description
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.
Detailed Description
The study will be a double blind 12-week controlled trial with two groups, one taking active drug (naltrexone) and the other receiving placebo. Patients on both groups will be assessed for GD symptoms and severity, major comorbid psychiatric disorders and related psychopathology (impulsivity, craving and locus of control), and eye-tracking patterns prior to and one hour after the administration of the first dose, one week after and at treatment completion.
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.
On the first day of evaluation patients will first be interviewed to check GD diagnosis and screen other medical conditions that may exclude patients from the trial. The selected individuals will be randomly assigned to either naltrexone or placebo group; After that they will answer several questionnaires and have the first eye tracking assessment. Each individual will receive either placebo or naltrexone and be assessed 1 hour after drug administration.
After the first week patients will have the third eye tracking assessment, as well as several questionnaires On the next weeks patients will be constantly monitored for side effects and gambling symptoms.
On the twelfth week patients will have the fourth and last eye tracking assessment During the 12-week trial both groups will have psychoeducational sessions, on weeks 2,4,6 and 8. During sessions patients have access to audio-visual material and receive Self-help material, this intervention is based on Hodgins proposal (Hodgins DC et al, 2005).
Adherence will be verified by counting pills consumed by the patient. In the weeks without face-to-face medical assessment, patients will be evaluated by telephone interview to monitor adverse effects of medication. If the evaluator identifies a worrying adverse reaction, the patient will be advised to anticipate the face-to-face interview.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Tracking, Gambling Disorder, Naltrexone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients receiving Naltrexone
Arm Type
Active Comparator
Arm Title
Patients receiving Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Gambling Follow up scale (GFS)
Time Frame
Day 0 and day 84
Secondary Outcome Measure Information:
Title
Gambling Self-Assessment Scale (G-SAS)
Time Frame
Day 0 and day 84
Title
Gamblers´ Beliefs Questionnaires (GBQ)
Time Frame
Day 0 and day 84
Title
Timeline Follow-Back Method, (TFB)
Time Frame
Day 0 and day 84
Title
Barratt Impulsiveness Scale, version 11
Time Frame
Day 0 and day 84
Title
Social Adjustment Scale self-report version
Time Frame
Day 0 and day 84
Title
Clinical Global Impression (CGI)
Time Frame
Day 0 and day 84
Other Pre-specified Outcome Measures:
Title
Locus of control scale internal- external
Time Frame
Day 0,day 7, and day 84
Title
Eye Tracking
Time Frame
Day 0, day 7 and day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria are:
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.
Exclusion Criteria:
1. 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hermano Tavares
Phone
55-11-26617805
Email
hermanoqt@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rache Takahashi
Phone
55 11 99517953
Email
chel_est89@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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RCT for Gambling and Naltrexone, Using Use Eye-tracking Analysis to Predict Treatment Response
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