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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021123-26 | EudraCT Number |
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The aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as combined with CBT-intervention in the treatment of pathological gambling (PG). The study period is 2011-2014 during which one hundred Pathological Gamblers will be recruited to participate to this placebo-controlled double-blind trial.
All participants have to be able to read and understand the patient information sheet and sign the informed consent. All participants are free to stop being in the study whenever they wanted. The patients are not paid or reimbursed for participation.
The study periods is 21 weeks during which the participant's have 8 appointments with the researchers. During the meetings research data will be collected and the participant is having Controlled Behavioral Therapy (CBT) consulting from a trained therapist. At the study visits, the subjects are given written instructions for the proper use of naltrexone and advised to take 50 mg naltrexone approximately one hour before gambling or feeling urges to gamble (and to refrain from taking naltrexone at other times). In this study the maximal daily dose is 50mg of naltrexone. The medication is free for the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo pill. | Placebo Comparator |
| |
| 50mg Naltrexone when needed | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone pharmacotherapy | Drug | Naltrexone 50mg when graving to gamble. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PG-YBOCS. | The investigators will interview PG-YBOCS questionnaire from the participants. | Up to 21 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol use. | The investigators will ask the participants to fill in AUDIT questionnaire. | Up to 21 weeks. |
| Quality of life. | The investigators will ask the participants to fill in RAND 36 questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannu Alho, Professor | Finnish Institute for Health and Welfare | Principal Investigator |
| Tuuli Lahti, Adjunct Professor | Finnish Institute for Health and Welfare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Health and Welfare | Helsinki | Uusimaa | 00530 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36130734 | Derived | 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. | |
| 26339899 | Derived | Kovanen L, Basnet S, Castren S, Pankakoski M, Saarikoski ST, Partonen T, Alho H, Lahti T. A Randomised, Double-Blind, Placebo-Controlled Trial of As-Needed Naltrexone in the Treatment of Pathological Gambling. Eur Addict Res. 2016;22(2):70-9. doi: 10.1159/000435876. Epub 2015 Sep 5. |
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| ID | Term |
|---|---|
| D005715 | Gambling |
| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| D001519 | Behavior |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D001523 | Mental Disorders |
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| Placebo |
| Drug |
Placebo pill with no active ingredients. |
|
| Up to 21 weeks. |