Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

Sponsor

Finnish Institute for Health and Welfare (Other)

Overall Status

Completed

CT.gov ID

NCT01528007

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pathological Gambling	Drug: Naltrexone pharmacotherapy Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo pill.	Drug: Placebo Placebo pill with no active ingredients.
Active Comparator: 50mg Naltrexone when needed	Drug: Naltrexone pharmacotherapy Naltrexone 50mg when graving to gamble.

Arm

Intervention/Treatment

Placebo Comparator: Placebo pill.

Drug: Placebo

Placebo pill with no active ingredients.

Active Comparator: 50mg Naltrexone when needed

Drug: Naltrexone pharmacotherapy

Naltrexone 50mg when graving to gamble.

Outcome Measures

Primary Outcome Measures

PG-YBOCS. [Up to 21 weeks.]
The investigators will interview PG-YBOCS questionnaire from the participants.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute for Health and Welfare	Helsinki	Uusimaa	Finland	00530

Sponsors and Collaborators

Finnish Institute for Health and Welfare

Investigators

Principal Investigator: Hannu Alho, Professor, Finnish Institute for Health and Welfare
Study Director: Tuuli Lahti, Adjunct Professor, Finnish Institute for Health and Welfare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hannu Alho, Professor, Finnish Institute for Health and Welfare

ClinicalTrials.gov Identifier:

NCT01528007

Other Study ID Numbers:

03062010
2010-021123-26

First Posted:

Feb 7, 2012

Last Update Posted:

Dec 5, 2013

Last Verified:

Dec 1, 2013

Keywords provided by Hannu Alho, Professor, Finnish Institute for Health and Welfare

Pathological gambling

Treatment intervention

Additional relevant MeSH terms:

Gambling

Naltrexone

Study Results

No Results Posted as of Dec 5, 2013