Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

Finnish Institute for Health and Welfare

Status and phase: Completed; Phase 4

Conditions: Pathological Gambling

Treatments: Drug: Naltrexone pharmacotherapy; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01528007

03062010

2010-021123-26 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo pill.

Placebo Comparator group

Treatment:

Drug: Placebo

50mg Naltrexone when needed

Active Comparator group

Treatment:

Drug: Naltrexone pharmacotherapy