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Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

NCT ID: NCT01528007

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Pathological Gambling

Keywords

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Pathological gambling Treatment intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo pill.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill with no active ingredients.

50mg Naltrexone when needed

Group Type ACTIVE_COMPARATOR

Naltrexone pharmacotherapy

Intervention Type DRUG

Naltrexone 50mg when graving to gamble.

Interventions

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Naltrexone pharmacotherapy

Naltrexone 50mg when graving to gamble.

Intervention Type DRUG

Placebo

Placebo pill with no active ingredients.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hannu Alho

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hannu Alho, Professor

Role: PRINCIPAL_INVESTIGATOR

Finnish Institute for Health and Welfare

Tuuli Lahti, Adjunct Professor

Role: STUDY_DIRECTOR

Finnish Institute for Health and Welfare

Locations

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National Institute for Health and Welfare

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 36130734 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26339899 (View on PubMed)

Other Identifiers

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2010-021123-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

03062010

Identifier Type: -

Identifier Source: org_study_id