Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention
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.
Drug: Naltrexone pharmacotherapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: No ]The investigators will interview PG-YBOCS questionnaire from the participants.
- Alcohol use. [ Time Frame: Up to 21 weeks. ] [ Designated as safety issue: No ]The investigators will ask the participants to fill in AUDIT questionnaire.
- Quality of life. [ Time Frame: Up to 21 weeks. ] [ Designated as safety issue: No ]The investigators will ask the participants to fill in RAND 36 questionnaire.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||January 2014 (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.
|Contact: Hannu Alho, Professoremail@example.com|
|Contact: Tuuli Lahti, Adjunct Professorfirstname.lastname@example.org|
|National Institute for Health and Welfare||Recruiting|
|Helsinki, Uusimaa, Finland, 00530|
|Contact: Hannu Alho, Professor +358206108123 email@example.com|
|Contact: Tuuli Lahti, Adjunct Professor +358206108908 firstname.lastname@example.org|
|Principal Investigator: Hannu Alho, Professor|
|Sub-Investigator: Tuuli Lahti, Adjunct Professor|
|Sub-Investigator: Sari Castren, M.Sc.|
|Sub-Investigator: Sirpa Päivinen, CRA|
|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|