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Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

This study is currently recruiting participants.
Verified February 2012 by National Institute for Health and Welfare, Finland
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: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pathological Gambling
 Drug: Naltrexone pharmacotherapy
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • PG-YBOCS. [ Time Frame: Up to 21 weeks. ] [ Designated as safety issue: No ]
    The investigators will interview PG-YBOCS questionnaire from the participants.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528007

Contacts
Contact: Hannu Alho, Professor +358206108123 hannu.alho@thl.fi
Contact: Tuuli Lahti, Adjunct Professor +358206103908 tuuli.lahti@thl.fi

Locations
Finland
National Institute for Health and Welfare Recruiting
Helsinki, Uusimaa, Finland, 00530
Contact: Hannu Alho, Professor     +358206108123     hannu.alho@thl.fi    
Contact: Tuuli Lahti, Adjunct Professor     +358206108908     tuuli.lahti@thl.fi    
Principal Investigator: Hannu Alho, Professor            
Sub-Investigator: Tuuli Lahti, Adjunct Professor            
Sub-Investigator: Sari Castren, M.Sc.            
Sub-Investigator: Sirpa Päivinen, CRA            
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Investigators
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
  More Information

No publications provided

Responsible Party: Hannu Alho, Professor, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01528007     History of Changes
Other Study ID Numbers: 03062010, 2010-021123-26
Study First Received: October 28, 2011
Last Updated: February 6, 2012
Health Authority: Finland: Finnish Medicines Agency
Finland: National Advisory Board on Health Care Ethics

Keywords provided by National Institute for Health and Welfare, Finland:
Pathological gambling
Treatment intervention

Additional relevant MeSH terms:
Gambling
Impulse Control Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013