NCT01528007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

2.7 years

First QC Date

October 28, 2011

Last Update Submit

December 4, 2013

Conditions

Pathological Gambling

Keywords

Pathological gamblingTreatment intervention

Outcome Measures

Primary Outcomes (1)

  • PG-YBOCS.

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

    Up to 21 weeks.

Secondary Outcomes (2)

  • Alcohol use.

    Up to 21 weeks.

  • Quality of life.

    Up to 21 weeks.

Study Arms (2)

Placebo pill.

PLACEBO COMPARATOR
Drug: Placebo

50mg Naltrexone when needed

ACTIVE COMPARATOR
Drug: Naltrexone pharmacotherapy

Interventions

Naltrexone pharmacotherapyDRUG

Naltrexone 50mg when graving to gamble.

50mg Naltrexone when needed
PlaceboDRUG

Placebo pill with no active ingredients.

Placebo pill.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pathological gambling (scores 5+ from SOGS-R and DSM-IV criteria)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Health and Welfare

Helsinki, Uusimaa, 00530, Finland

Location

Related Publications (2)

  • 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.

    PMID: 36130734DERIVED

  • 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.

    PMID: 26339899DERIVED

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Hannu Alho, Professor

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

  • Tuuli Lahti, Adjunct Professor

    Finnish Institute for Health and Welfare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2011

First Posted

February 7, 2012

Study Start

January 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations

FI(1)