Clinical Trial: Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary:

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.


Sponsor: National Institute for Health and Welfare, Finland

Current Primary Outcome: PG-YBOCS. [ Time Frame: Up to 21 weeks. ]

The investigators will interview PG-YBOCS questionnaire from the participants.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: National Institute for Health and Welfare, Finland

Dates:
Date Received: October 28, 2011
Date Started: January 2011
Date Completion:
Last Updated: December 4, 2013
Last Verified: December 2013