Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention
|Pathological Gambling||Drug: Naltrexone pharmacotherapy Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial|
- PG-YBOCS. [ Time Frame: Up to 21 weeks. ]The investigators will interview PG-YBOCS questionnaire from the participants.
- Alcohol use. [ Time Frame: Up to 21 weeks. ]The investigators will ask the participants to fill in AUDIT questionnaire.
- Quality of life. [ Time Frame: Up to 21 weeks. ]The investigators will ask the participants to fill in RAND 36 questionnaire.
|Study Start Date:||January 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo pill.||
Placebo pill with no active ingredients.
|Active Comparator: 50mg Naltrexone when needed||
Drug: Naltrexone pharmacotherapy
Naltrexone 50mg when graving to gamble.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528007
|National Institute for Health and Welfare|
|Helsinki, Uusimaa, Finland, 00530|
|Principal Investigator:||Hannu Alho, Professor||National Institute for Health and Welfare, Finland|
|Study Director:||Tuuli Lahti, Adjunct Professor||National Institute for Health and Welfare, Finland|