Clinical trial NCT01528007: Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention
Official title: Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pathological Gambling
Keywords: Pathological gambling
Treatment intervention
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
First posted: 2012-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PG-YBOCS.
timeFrame: Up to 21 weeks.
Secondary outcomes:
measure: Alcohol use.
timeFrame: Up to 21 weeks.
measure: Quality of life.
timeFrame: Up to 21 weeks.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Institute for Health and Welfare
state: Uusimaa
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Hannu Alho, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Finnish Institute for Health and Welfare
name: Tuuli Lahti, Adjunct Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.