drugset / Trial / NCT04738773
RCT for Gambling and Naltrexone, Using Use Eye-tracking Analysis to Predict Treatment Response
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2021-06-01
- Primary completion
- 2022-07
- Completion
- 2023-12
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Nestler EJ. From neurobiology to treatment: progress against addiction. Nat Neurosci. 2002 Nov;5 Suppl:1076-9. doi: 10.1038/nn945.
- Background 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.
- Background Robinson TE, Berridge KC. Addiction. Annu Rev Psychol. 2003;54:25-53. doi: 10.1146/annurev.psych.54.101601.145237. Epub 2002 Jun 10.
- Background Robinson TE, Berridge KC. Incentive-sensitization and addiction. Addiction. 2001 Jan;96(1):103-14. doi: 10.1046/j.1360-0443.2001.9611038.x.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naltrexone | Small molecule | 200 mg | Oral |