Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial

Conditions
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Pathological Gambling

Intervention / Treatment
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* Drug: Naltrexone pharmacotherapy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathological gambling (scores 5+ from SOGS-R and DSM-IV criteria) Exclusion Criteria: acute hepatitis severe liver or kidney dysfunction suicide risk or severe depression or other untreated mental health problem participation to other gambling research at the same time the use of drugs (especially opiates) pregnancy prisoners retarded and mentally ill patients were also excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo pill.<br> | Drug: Placebo<br>* Placebo pill with no active ingredients.<br>|
| Active Comparator: 50mg Naltrexone when needed<br> | Drug: Naltrexone pharmacotherapy<br>* Naltrexone 50mg when graving to gamble.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PG-YBOCS. | The investigators will interview PG-YBOCS questionnaire from the participants. | Up to 21 weeks. | 

Secondary Outcome Measures

| Outcome Measure | 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. | Up to 21 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pathological gambling, Treatment intervention