Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

Concurrent Alcohol Dependence and Pathological Gambling Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial of Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326807
• Other study ID #: 095/2001
• Status: Completed
• Phase: N/A
• First received: May 15, 2006
• Last updated: May 15, 2006
• Start date: June 2001
• Est. completion date: June 2004

Study information

• Verified date: May 2006
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Concurrent Alcohol Dependence and Pathological Gambling
• Gambling

Intervention

Drug:
• Naltrexone

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Finland	National Public Health Institute	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Countries where clinical trial is conducted

Canada,  Finland, 

References & Publications (6)

Anton RF, Moak DH, Latham P, Waid LR, Myrick H, Voronin K, Thevos A, Wang W, Woolson R. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005 Aug;25(4):349-57. — View Citation

Chick J, Anton R, Checinski K, Croop R, Drummond DC, Farmer R, Labriola D, Marshall J, Moncrieff J, Morgan MY, Peters T, Ritson B. A multicentre, randomized, double-blind, placebo-controlled trial of naltrexone in the treatment of alcohol dependence or abuse. Alcohol Alcohol. 2000 Nov-Dec;35(6):587-93. — View Citation

Crockford DN, el-Guebaly N. Naltrexone in the treatment of pathological gambling and alcohol dependence. Can J Psychiatry. 1998 Feb;43(1):86. — View Citation

Feigelman W, Wallisch LS, Lesieur HR. Problem gamblers, problem substance users, and dual-problem individuals: an epidemiological study. Am J Public Health. 1998 Mar;88(3):467-70. — View Citation

Gianoulakis C. Endogenous opioids and excessive alcohol consumption. J Psychiatry Neurosci. 1993 Jul;18(4):148-56. Review. — View Citation

Heinälä P, Alho H, Kiianmaa K, Lönnqvist J, Kuoppasalmi K, Sinclair JD. Targeted use of naltrexone without prior detoxification in the treatment of alcohol dependence: a factorial double-blind, placebo-controlled trial. J Clin Psychopharmacol. 2001 Jun;21(3):287-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gambling Urge Questionnaire
Primary	Obsessive Compulsive Drinking Scale
Primary	Readiness to Change Questionnaire
Primary	Frequency of drinking/gambling
Primary	Amount of drinking/gambling
Primary	Money spent of gambling

External Links

•   institution link