Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01528007

Enrollment

100

Registered

2012-02-07

Start date

2011-01-31

Completion date

2013-09-30

Last updated

2013-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pathological Gambling

Keywords

Pathological gambling, Treatment intervention

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.

Interventions

DRUGNaltrexone pharmacotherapy

Naltrexone 50mg when graving to gamble.

DRUGPlacebo

Placebo pill with no active ingredients.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
PG-YBOCS.	Up to 21 weeks.	The investigators will interview PG-YBOCS questionnaire from the participants.

Secondary

Measure	Time frame	Description
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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026