Eye TrackingPhase 2NCT04738773
RCT for Gambling and Naltrexone, Using Use Eye-tracking Analysis to Predict Treatment Response
A Phase 2 study testing Naltrexone in people with Eye Tracking and Gambling Disorder, run by University of Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Tracking, Gambling Disorder, Naltrexone
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Eye Tracking, Gambling Disorder, Naltrexone
- Being tested
- Naltrexone, Placebo
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
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.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Naltrexone | Active comparator | Not described Receives: Drug: Naltrexone |
| Patients receiving Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gambling Follow up scale (GFS)
Measured: Day 0 and day 84
Secondary outcomes (6)
Gambling Self-Assessment Scale (G-SAS)
Measured: Day 0 and day 84
Gamblers´ Beliefs Questionnaires (GBQ)
Measured: Day 0 and day 84
Timeline Follow-Back Method, (TFB)
Measured: Day 0 and day 84
Barratt Impulsiveness Scale, version 11
Measured: Day 0 and day 84
Social Adjustment Scale self-report version
Measured: Day 0 and day 84
Clinical Global Impression (CGI)
Measured: Day 0 and day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Jun 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Eye TrackingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermano Tavares, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738773
- Sponsor's protocol ID
- Gambling Natrexone ET
- Status last verified
- Jan 2021
- First submitted
- 31 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21569055Anton 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.
PubMed 10553740Brevers 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.
PubMed 21688874Field 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.
PubMed 15072814Field 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.
PubMed 15071718Galetti 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.
PubMed 27828667Garbutt 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.
PubMed 24661324Grant 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.
PubMed 24871298Grant 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.
PubMed 18384246Hendershot 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.
PubMed 27411969Hodgins 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.
PubMed 15789185Kim 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.
PubMed 11552772Kim 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.
PubMed 11377409Lahti 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.
PubMed 21150845Lole 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.
PubMed 31446764
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04738773
- Acronym / sponsor ID
- Gambling Natrexone ET
- Conditions
- Eye Tracking, Gambling Disorder, Naltrexone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Naltrexone | Active comparator | Drug: Naltrexone |
| Patients receiving Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The inclusion criteria are:
Key exclusion criteria (1 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneOn 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. | Drug | Patients receiving Naltrexone |
| PlaceboPlacebo | Drug | Patients receiving Placebo |
Primary outcome
Gambling Follow up scale (GFS)
Time frame: Day 0 and day 84
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 21569055Altamirano 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: PubMed 10553740Anton 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: PubMed 21688874Brevers 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: PubMed 15072814Field 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: PubMed 15071718Field 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: PubMed 27828667Galetti 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: PubMed 24661324Garbutt 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: PubMed 24871298Grant 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: PubMed 18384246Grant 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: PubMed 27411969Hendershot 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: PubMed 15789185Hodgins 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: PubMed 11552772Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone in people with Eye Tracking and Gambling Disorder, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hermano Tavares (55-11-26617805, hermanoqt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gambling Follow up scale (GFS) (time frame: Day 0 and day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738773, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.