Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01528007|
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : December 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pathological Gambling||Drug: Naltrexone pharmacotherapy Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
|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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|