NCT Number: NCT00326807
Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling
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.
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Centre for Addiction and Mental Health, Toronto, Ontario, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Gambling Urge Questionnaire
-
Obsessive Compulsive Drinking Scale
-
Readiness to Change Questionnaire
-
Frequency of drinking/gambling
-
Amount of drinking/gambling
-
Money spent of gambling
Sponsors and collaborators
Lead sponsor
Centre for Addiction and Mental Health
Other
Registry information
Official study title
A Randomized, Double-Blind, Placebo-Controlled Trial of Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling
Important dates
- Study start
- 2001
- Study completion
- 2004
- First posted
- May 17, 2006
- Registry last updated
- May 17, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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