Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Pathological Gambling
• Intervention / Treatment: Drug: Placebo; Drug: Naltrexone pharmacotherapy

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00530
      • National Institute for Health and Welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol use.	The investigators will ask the participants to fill in AUDIT questionnaire.	Up to 21 weeks.
Quality of life.	The investigators will ask the participants to fill in RAND 36 questionnaire.	Up to 21 weeks.

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Estimate): December 5, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Pathological gambling; Treatment intervention
• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: 03062010; 2010-021123-26 (EudraCT Number)