Status:
UNKNOWN
RCT for Gambling and Naltrexone, Using Use Eye-tracking Analysis to Predict Treatment Response
Lead Sponsor:
University of Sao Paulo
Conditions:
Eye Tracking
Gambling Disorder
Eligibility:
All Genders
21-60 years
Phase:
PHASE2
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04738773
Start Date
June 1 2021
End Date
December 1 2023
Last Update
February 4 2021
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