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Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

Primary Purpose

Pathological Gambling

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Naltrexone pharmacotherapy
Placebo
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Gambling focused on measuring Pathological gambling, Treatment intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute for Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo pill.

50mg Naltrexone when needed

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Alcohol use.
The investigators will ask the participants to fill in AUDIT questionnaire.
Quality of life.
The investigators will ask the participants to fill in RAND 36 questionnaire.

Full Information

First Posted
October 28, 2011
Last Updated
December 4, 2013
Sponsor
Finnish Institute for Health and Welfare
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1. Study Identification

Unique Protocol Identification Number
NCT01528007
Brief Title
Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention
Official Title
Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Finnish Institute for Health and Welfare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
Keywords
Pathological gambling, Treatment intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo pill.
Arm Type
Placebo Comparator
Arm Title
50mg Naltrexone when needed
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone pharmacotherapy
Intervention Description
Naltrexone 50mg when graving to gamble.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill with no active ingredients.
Primary Outcome Measure Information:
Title
PG-YBOCS.
Description
The investigators will interview PG-YBOCS questionnaire from the participants.
Time Frame
Up to 21 weeks.
Secondary Outcome Measure Information:
Title
Alcohol use.
Description
The investigators will ask the participants to fill in AUDIT questionnaire.
Time Frame
Up to 21 weeks.
Title
Quality of life.
Description
The investigators will ask the participants to fill in RAND 36 questionnaire.
Time Frame
Up to 21 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu Alho, Professor
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tuuli Lahti, Adjunct Professor
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
Facility Information:
Facility Name
National Institute for Health and Welfare
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00530
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
36130734
Citation
Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
Results Reference
derived
PubMed Identifier
26339899
Citation
Kovanen L, Basnet S, Castren S, Pankakoski M, Saarikoski ST, Partonen T, Alho H, Lahti T. A Randomised, Double-Blind, Placebo-Controlled Trial of As-Needed Naltrexone in the Treatment of Pathological Gambling. Eur Addict Res. 2016;22(2):70-9. doi: 10.1159/000435876. Epub 2015 Sep 5.
Results Reference
derived

Learn more about this trial

Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

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