Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

Phase 4

Completed

• Conditions: Pathological Gambling
• Interventions: Drug: Placebo; Drug: Naltrexone pharmacotherapy

• Registration Number: NCT01528007
• Lead Sponsor: Finnish Institute for Health and Welfare

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 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-04
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo pill.	Placebo	-
50mg Naltrexone when needed	Naltrexone pharmacotherapy	-

Primary Outcome Measures

Name	Time	Method
PG-YBOCS.	Up to 21 weeks.	The investigators will interview PG-YBOCS questionnaire from the participants.

Secondary Outcome Measures

Name	Time	Method
Alcohol use.	Up to 21 weeks.	The investigators will ask the participants to fill in AUDIT questionnaire.
Quality of life.	Up to 21 weeks.	The investigators will ask the participants to fill in RAND 36 questionnaire.

Trial Locations

Locations (1)

National Institute for Health and Welfare; 🇫🇮 Helsinki, Uusimaa, Finland