Skip to main content
OpenTrials
Completed

NCT Number: NCT01528007

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Institute for Health and Welfare

Helsinki, Uusimaa, 00530, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone pharmacotherapy

Drug

Naltrexone 50mg when graving to gamble.

Placebo

Drug

Placebo pill with no active ingredients.

Primary outcomes

  1. PG-YBOCS.

    Time frame: Up to 21 weeks.

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

Secondary outcomes

  1. Alcohol use.

    Time frame: Up to 21 weeks.

    The investigators will ask the participants to fill in AUDIT questionnaire.

  2. Quality of life.

    Time frame: Up to 21 weeks.

    The investigators will ask the participants to fill in RAND 36 questionnaire.

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2012
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.