A Phase 2 interventional study of Naltrexone and Placebo in Eye Tracking, Gambling Disorder and Naltrexone, sponsored by University of Sao Paulo. Status unknown. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment
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.
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.
147 studies on the registry are indexed under Gambling; 35 are open to participants now.
This study's planned enrollment of 40 is below the median of 65 across 119 interventional studies indexed under Gambling.
Browse Gambling studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria are:
Female patients should be:
Exclusion Criteria:
Drug: Naltrexone
Drug: Placebo
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.
Placebo
Gambling Follow up scale (GFS)
Time frame: Day 0 and day 84
Gambling Self-Assessment Scale (G-SAS)
Time frame: Day 0 and day 84
Gamblers´ Beliefs Questionnaires (GBQ)
Time frame: Day 0 and day 84
Timeline Follow-Back Method, (TFB)
Time frame: Day 0 and day 84
Barratt Impulsiveness Scale, version 11
Time frame: Day 0 and day 84
Social Adjustment Scale self-report version
Time frame: Day 0 and day 84
Clinical Global Impression (CGI)
Time frame: Day 0 and day 84
Locus of control scale internal- external
Time frame: Day 0,day 7, and day 84
Eye Tracking
Time frame: Day 0, day 7 and day 84
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo