search
Back to results

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
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Tracking

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The inclusion criteria are:

    1. Men and woman aged 21 to 60 years;
    2. 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);
    3. 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

    First Posted
    January 31, 2021
    Last Updated
    February 3, 2021
    Sponsor
    University of Sao Paulo
    search

    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
    Citations:
    PubMed Identifier
    21569055
    Citation
    Altamirano LJ, Fields HL, D'Esposito M, Boettiger CA. Interaction between family history of alcoholism and Locus of Control in the opioid regulation of impulsive responding under the influence of alcohol. Alcohol Clin Exp Res. 2011 Nov;35(11):1905-14. doi: 10.1111/j.1530-0277.2011.01535.x. Epub 2011 May 13.
    Results Reference
    background
    PubMed Identifier
    10553740
    Citation
    Anton RF, Moak DH, Waid LR, Latham PK, Malcolm RJ, Dias JK. Naltrexone and cognitive behavioral therapy for the treatment of outpatient alcoholics: results of a placebo-controlled trial. Am J Psychiatry. 1999 Nov;156(11):1758-64. doi: 10.1176/ajp.156.11.1758.
    Results Reference
    background
    PubMed Identifier
    21688874
    Citation
    Brevers D, Cleeremans A, Bechara A, Laloyaux C, Kornreich C, Verbanck P, Noel X. Time course of attentional bias for gambling information in problem gambling. Psychol Addict Behav. 2011 Dec;25(4):675-82. doi: 10.1037/a0024201. Epub 2011 Jun 20.
    Results Reference
    background
    PubMed Identifier
    15072814
    Citation
    Field M, Mogg K, Bradley BP. Cognitive bias and drug craving in recreational cannabis users. Drug Alcohol Depend. 2004 Apr 9;74(1):105-11. doi: 10.1016/j.drugalcdep.2003.12.005.
    Results Reference
    background
    PubMed Identifier
    15071718
    Citation
    Field M, Mogg K, Zetteler J, Bradley BP. Attentional biases for alcohol cues in heavy and light social drinkers: the roles of initial orienting and maintained attention. Psychopharmacology (Berl). 2004 Oct;176(1):88-93. doi: 10.1007/s00213-004-1855-1. Epub 2004 Apr 8.
    Results Reference
    background
    PubMed Identifier
    27828667
    Citation
    Galetti AM, Tavares H. Development and validation of the Gambling Follow-up Scale, Self-Report version: an outcome measure in the treatment of pathological gambling. Braz J Psychiatry. 2017 Jan-Mar;39(1):36-44. doi: 10.1590/1516-4446-2016-1911. Epub 2016 Nov 7.
    Results Reference
    background
    PubMed Identifier
    24661324
    Citation
    Garbutt JC, Greenblatt AM, West SL, Morgan LC, Kampov-Polevoy A, Jordan HS, Bobashev GV. Clinical and biological moderators of response to naltrexone in alcohol dependence: a systematic review of the evidence. Addiction. 2014 Aug;109(8):1274-84. doi: 10.1111/add.12557. Epub 2014 May 23.
    Results Reference
    background
    PubMed Identifier
    24871298
    Citation
    Grant LD, Bowling AC. Gambling Attitudes and Beliefs Predict Attentional Bias in Non-problem Gamblers. J Gambl Stud. 2015 Dec;31(4):1487-503. doi: 10.1007/s10899-014-9468-z.
    Results Reference
    background
    PubMed Identifier
    18384246
    Citation
    Grant JE, Kim SW, Hartman BK. A double-blind, placebo-controlled study of the opiate antagonist naltrexone in the treatment of pathological gambling urges. J Clin Psychiatry. 2008 May;69(5):783-9. doi: 10.4088/jcp.v69n0511.
    Results Reference
    background
    PubMed Identifier
    27411969
    Citation
    Hendershot CS, Wardell JD, Samokhvalov AV, Rehm J. Effects of naltrexone on alcohol self-administration and craving: meta-analysis of human laboratory studies. Addict Biol. 2017 Nov;22(6):1515-1527. doi: 10.1111/adb.12425. Epub 2016 Jul 14.
    Results Reference
    background
    PubMed Identifier
    15789185
    Citation
    Hodgins DC. Implications of a brief intervention trial for problem gambling for future outcome research. J Gambl Stud. 2005 Spring;21(1):13-9. doi: 10.1007/s10899-004-1917-7.
    Results Reference
    background
    PubMed Identifier
    11552772
    Citation
    Kim SW, Grant JE. An open naltrexone treatment study in pathological gambling disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):285-9. doi: 10.1097/00004850-200109000-00006.
    Results Reference
    background
    PubMed Identifier
    11377409
    Citation
    Kim SW, Grant JE, Adson DE, Shin YC. Double-blind naltrexone and placebo comparison study in the treatment of pathological gambling. Biol Psychiatry. 2001 Jun 1;49(11):914-21. doi: 10.1016/s0006-3223(01)01079-4.
    Results Reference
    background
    PubMed Identifier
    21150845
    Citation
    Lahti T, Halme JT, Pankakoski M, Sinclair D, Alho H. Treatment of pathological gambling with naltrexone pharmacotherapy and brief intervention: a pilot study. Psychopharmacol Bull. 2010;43(3):35-44.
    Results Reference
    background
    PubMed Identifier
    31446764
    Citation
    Lole L, Li E, Russell AM, Greer N, Thorne H, Hing N. Are sports bettors looking at responsible gambling messages? An eye-tracking study on wagering advertisements. J Behav Addict. 2019 Sep 1;8(3):499-507. doi: 10.1556/2006.8.2019.37. Epub 2019 Aug 26.
    Results Reference
    background
    PubMed Identifier
    29385164
    Citation
    McGrath DS, Meitner A, Sears CR. The specificity of attentional biases by type of gambling: An eye-tracking study. PLoS One. 2018 Jan 31;13(1):e0190614. doi: 10.1371/journal.pone.0190614. eCollection 2018.
    Results Reference
    background
    PubMed Identifier
    17047667
    Citation
    Mitchell JM, Tavares VC, Fields HL, D'Esposito M, Boettiger CA. Endogenous opioid blockade and impulsive responding in alcoholics and healthy controls. Neuropsychopharmacology. 2007 Feb;32(2):439-49. doi: 10.1038/sj.npp.1301226. Epub 2006 Oct 18.
    Results Reference
    background
    PubMed Identifier
    12403990
    Citation
    Nestler EJ. From neurobiology to treatment: progress against addiction. Nat Neurosci. 2002 Nov;5 Suppl:1076-9. doi: 10.1038/nn945.
    Results Reference
    background
    PubMed Identifier
    8837932
    Citation
    O'Brien CP, Volpicelli LA, Volpicelli JR. Naltrexone in the treatment of alcoholism: a clinical review. Alcohol. 1996 Jan-Feb;13(1):35-9. doi: 10.1016/0741-8329(95)02038-1.
    Results Reference
    background
    PubMed Identifier
    12185211
    Citation
    Robinson TE, Berridge KC. Addiction. Annu Rev Psychol. 2003;54:25-53. doi: 10.1146/annurev.psych.54.101601.145237. Epub 2002 Jun 10.
    Results Reference
    background
    PubMed Identifier
    11177523
    Citation
    Robinson TE, Berridge KC. Incentive-sensitization and addiction. Addiction. 2001 Jan;96(1):103-14. doi: 10.1046/j.1360-0443.2001.9611038.x.
    Results Reference
    background
    PubMed Identifier
    30171914
    Citation
    Ruddock HK, Field M, Jones A, Hardman CA. State and trait influences on attentional bias to food-cues: The role of hunger, expectancy, and self-perceived food addiction. Appetite. 2018 Dec 1;131:139-147. doi: 10.1016/j.appet.2018.08.038. Epub 2018 Aug 29.
    Results Reference
    background
    PubMed Identifier
    11139409
    Citation
    Sinclair JD. Evidence about the use of naltrexone and for different ways of using it in the treatment of alcoholism. Alcohol Alcohol. 2001 Jan-Feb;36(1):2-10. doi: 10.1093/alcalc/36.1.2.
    Results Reference
    background
    PubMed Identifier
    9054347
    Citation
    Schultz W, Dayan P, Montague PR. A neural substrate of prediction and reward. Science. 1997 Mar 14;275(5306):1593-9. doi: 10.1126/science.275.5306.1593.
    Results Reference
    background
    PubMed Identifier
    24824822
    Citation
    Vitaro F, Hartl AC, Brendgen M, Laursen B, Dionne G, Boivin M. Genetic and environmental influences on gambling and substance use in early adolescence. Behav Genet. 2014 Jul;44(4):347-55. doi: 10.1007/s10519-014-9658-6. Epub 2014 May 14.
    Results Reference
    background
    PubMed Identifier
    1345133
    Citation
    Volpicelli JR, Alterman AI, Hayashida M, O'Brien CP. Naltrexone in the treatment of alcohol dependence. Arch Gen Psychiatry. 1992 Nov;49(11):876-80. doi: 10.1001/archpsyc.1992.01820110040006.
    Results Reference
    background
    PubMed Identifier
    9340756
    Citation
    Wickelgren I. Getting the brain's attention. Science. 1997 Oct 3;278(5335):35-7. doi: 10.1126/science.278.5335.35. No abstract available.
    Results Reference
    background
    PubMed Identifier
    25583563
    Citation
    Wilcockson TDW, Pothos EM. Measuring inhibitory processes for alcohol-related attentional biases: introducing a novel attentional bias measure. Addict Behav. 2015 May;44:88-93. doi: 10.1016/j.addbeh.2014.12.015. Epub 2014 Dec 27.
    Results Reference
    background
    PubMed Identifier
    25747926
    Citation
    Yau YH, Potenza MN. Gambling disorder and other behavioral addictions: recognition and treatment. Harv Rev Psychiatry. 2015 Mar-Apr;23(2):134-46. doi: 10.1097/HRP.0000000000000051.
    Results Reference
    background
    PubMed Identifier
    36130734
    Citation
    Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs