Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

Pathological Gambling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528007
• Other study ID #: 03062010
• Secondary ID: 2010-021123-26
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2011
• Last updated: December 4, 2013
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyFinland: National Advisory Board on Health Care Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gambling
• Pathological Gambling

Intervention

Drug:
• Naltrexone pharmacotherapy
Naltrexone 50mg when graving to gamble.
• Placebo
Placebo pill with no active ingredients.

Locations

Country	Name	City	State
Finland	National Institute for Health and Welfare	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PG-YBOCS.	The investigators will interview PG-YBOCS questionnaire from the participants.	Up to 21 weeks.	No
Secondary	Alcohol use.	The investigators will ask the participants to fill in AUDIT questionnaire.	Up to 21 weeks.	No
Secondary	Quality of life.	The investigators will ask the participants to fill in RAND 36 questionnaire.	Up to 21 weeks.	No