Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hannu Alho, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT01528007
First received: October 28, 2011
Last updated: December 4, 2013
Last verified: December 2013

October 28, 2011
December 4, 2013
January 2011
September 2013   (final data collection date for primary outcome measure)
PG-YBOCS. [ Time Frame: Up to 21 weeks. ] [ Designated as safety issue: No ]
The investigators will interview PG-YBOCS questionnaire from the participants.
Same as current
Complete list of historical versions of study NCT01528007 on ClinicalTrials.gov Archive Site
  • Alcohol use. [ Time Frame: Up to 21 weeks. ] [ Designated as safety issue: No ]
    The investigators will ask the participants to fill in AUDIT questionnaire.
  • Quality of life. [ Time Frame: Up to 21 weeks. ] [ Designated as safety issue: No ]
    The investigators will ask the participants to fill in RAND 36 questionnaire.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pathological Gambling
  • Drug: Naltrexone pharmacotherapy
    Naltrexone 50mg when graving to gamble.
  • Drug: Placebo
    Placebo pill with no active ingredients.
  • Placebo Comparator: Placebo pill.
    Intervention: Drug: Placebo
  • Active Comparator: 50mg Naltrexone when needed
    Intervention: Drug: Naltrexone pharmacotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01528007
03062010, 2010-021123-26
No
Hannu Alho, National Institute for Health and Welfare, Finland
National Institute for Health and Welfare, Finland
Not Provided
Principal Investigator: Hannu Alho, Professor National Institute for Health and Welfare, Finland
Study Director: Tuuli Lahti, Adjunct Professor National Institute for Health and Welfare, Finland
National Institute for Health and Welfare, Finland
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP