Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04738773
Study type Interventional
Source University of Sao Paulo
Contact Hermano Tavares
Phone 55-11-26617805
Email hermanoqt@gmail.com
Status Not yet recruiting
Phase Phase 2
Start date June 1, 2021
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03614884 - Effectiveness of an Online Integrated Treatment for Problem Gambling and Tobacco Smoking N/A
Completed NCT03946098 - ICBTG in Routine Care N/A
Completed NCT03725735 - Emotion Regulation Group Treatment for Gambling Disorder - a Pilot Trial N/A
Not yet recruiting NCT05331612 - Blended Treatment for Problem Gambling and Gambling Disorder Combining Group Sessions and Online Modules N/A
Completed NCT03145792 - Online Coping Skills Counseling for Problem Gambling and Trauma N/A
Not yet recruiting NCT03280966 - Effects of Intranasal Naloxone on Gambling Urges in Gambling Disorder Phase 2
Recruiting NCT02953899 - Contingency Management as an Adjunct Treatment for Rural and Remote Disordered Gamblers N/A
Recruiting NCT05686772 - Prospective Multicenter Cohort Study Evaluating the Incidence and Risk Factors for Problem Gambling Among Young Adults With First-episode Psychosis
Recruiting NCT03336879 - Repetitive Transcranial Magnetic Stimulation in Gambling Disorder N/A
Recruiting NCT05413564 - Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations N/A
Recruiting NCT03669315 - Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation Phase 3
Recruiting NCT05833503 - Integrative Couple Treatment for Gambling/Substance Use Disorder N/A
Completed NCT03477799 - The Effect of Transcranial Direct Current Stimulation on Decision Making and Cognitive Flexibility in Gambling Disorder Phase 3
Active, not recruiting NCT03497247 - Mindfulness-Based Cognitive-Behavioral Therapy for Gambling Disorder N/A
Recruiting NCT04646421 - Responsible Gambling Telephone Intervention to High-risk Gamblers by a State-owned Gambling Operator in Sweden.
Completed NCT03354702 - Physical Activity Pathological Gamblers N/A
Completed NCT03287583 - SBIRT Intervention for Gambling Behaviors N/A
Not yet recruiting NCT04158037 - Don't Go There: A Geospatial mHealth App for Gambling Disorder N/A
Not yet recruiting NCT06467422 - Effects of Transcranial Temporal Interference Stimulation on Risky Decision-making and Impulse Control in Gambling Disorder N/A
Not yet recruiting NCT03493399 - Testing Interference-based Methods to Mitigate Gambling Craving - A Multiple Single Case Design N/A