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Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00326807
Recruitment Status : Completed
First Posted : May 17, 2006
Last Update Posted : May 17, 2006
Sponsor:
Information provided by:
Centre for Addiction and Mental Health

Tracking Information
First Submitted Date  ICMJE May 15, 2006
First Posted Date  ICMJE May 17, 2006
Last Update Posted Date May 17, 2006
Study Start Date  ICMJE June 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2006)
  • Gambling Urge Questionnaire
  • Obsessive Compulsive Drinking Scale
  • Readiness to Change Questionnaire
  • Frequency of drinking/gambling
  • Amount of drinking/gambling
  • Money spent of gambling
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Trial of Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling
Brief Summary This study assessed whether naltrexone, an opioid antagonist, might be effective in reducing excessive gambling behavior in people who also drink heavily. The efficacy of naltrexone was evaluated in a randomized, double-blind, placebo-controlled trial. Fifty-two subjects who had significant problems with both gambling and alcohol received 11 weeks of either naltrexone or placebo.
Detailed Description With the growing popularity of gambling, there has been an increase in the number of individuals with problem gambling. As we learn more about the way we can help problem gamblers, there is a great interest developing effective medications for this problem. Although there is much to learn about the factors that lead to gambling problems, there is some research showing that one of the reasons why gambling may be so rewarding and difficult to stop is due to the release of endogenous opioids, a specific brain chemical that is associated with the feeling of pleasure. It is possible that medications known to affect the opioidergic neurotransmitter system which produces endogenous opioids may be beneficial in reducing pathological gambling. One such medication is naltrexone, an opioid antagonist, that has been shown to be effective in reducing alcohol consumption and approved for use in the treatment of alcohol dependence. This study assessed whether naltrexone might be effective in reducing excessive gambling behavior in people who also drink heavily. The efficacy of naltrexone was evaluated in a randomized, double-blind, placebo-controlled trial. Fifty-two subjects who had significant problems with both gambling and alcohol received 11 weeks of either naltrexone or placebo. Everyone also received 7 weeks of cognitive-behavioral counselling to help them reduce or stop drinking and gambling. Changes in alcohol and gambling behavior were measured at the beginning of treatment, at the end-of-treatment and 3, 6 and 12-months after treatment follow-up. The results showed that there were no significant differences between those who received placebo versus those who received naltrexone on any alcohol or gambling measure (i.e., frequency of drinking/ gambling, amount of drinking/ gambling, money spent of gambling, urges to drink/ gamble). However, treatment in general was effective as everyone, regardless of the treatment they received, were gambling and drinking significantly less at the end-of-treatment and during the year follow-up. The conclusion of the study was that naltrexone was not an effective treatment for concurrent alcohol use and gambling problems.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Concurrent Alcohol Dependence and Pathological Gambling
Intervention  ICMJE Drug: Naltrexone
Study Arms  ICMJE Not Provided
Publications *

*   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
Enrollment  ICMJE
 (submitted: May 15, 2006)
50
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • DSM-IV diagnosis of alcohol abuse and dependence
  • Diagnosis of pathological gambling
  • Drinking on at least 50% of the days in the preceding month
  • Gambling at least weekly in the month prior to assessment

Exclusion Criteria:

  • Dependence or abuse of any other psychoactive substances (except for nicotine dependence)
  • Concurrent diagnoses of any other psychiatric disorder,
  • Serious medical illness
  • Laboratory evidence of significant hepatocellular injury
  • Use of disulfiramuse and/or opioid-containing medications
  • Psychosocial crisis
  • Pregnancy
  • Inability to read or write English.
  • Poor motivation to change alcohol or gambling behavior
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 Canada,   Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00326807
Other Study ID Numbers  ICMJE 095/2001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tony Toneatto, PhD Centre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date May 2006

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