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Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

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ClinicalTrials.gov Identifier: NCT01528007
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : December 5, 2013
Sponsor:
Information provided by (Responsible Party):
Hannu Alho, National Institute for Health and Welfare, Finland

Tracking Information
First Submitted Date  ICMJE October 28, 2011
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date December 5, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
PG-YBOCS. [ Time Frame: Up to 21 weeks. ]
The investigators will interview PG-YBOCS questionnaire from the participants.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01528007 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
  • Alcohol use. [ Time Frame: Up to 21 weeks. ]
    The investigators will ask the participants to fill in AUDIT questionnaire.
  • Quality of life. [ Time Frame: Up to 21 weeks. ]
    The investigators will ask the participants to fill in RAND 36 questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention
Official Title  ICMJE Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pathological Gambling
Intervention  ICMJE
  • Drug: Naltrexone pharmacotherapy
    Naltrexone 50mg when graving to gamble.
  • Drug: Placebo
    Placebo pill with no active ingredients.
Study Arms  ICMJE
  • Placebo Comparator: Placebo pill.
    Intervention: Drug: Placebo
  • Active Comparator: 50mg Naltrexone when needed
    Intervention: Drug: Naltrexone pharmacotherapy
Publications * Kovanen L, Basnet S, Castrén 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528007
Other Study ID Numbers  ICMJE 03062010
2010-021123-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hannu Alho, National Institute for Health and Welfare, Finland
Study Sponsor  ICMJE National Institute for Health and Welfare, Finland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account National Institute for Health and Welfare, Finland
Verification Date December 2013

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