Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

This study has been completed.
Sponsor:
Information provided by:
Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00326807
First received: May 15, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Concurrent Alcohol Dependence and Pathological Gambling
Drug: Naltrexone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Gambling Urge Questionnaire
  • Obsessive Compulsive Drinking Scale
  • Readiness to Change Questionnaire
  • Frequency of drinking/gambling
  • Amount of drinking/gambling
  • Money spent of gambling

Estimated Enrollment: 50
Study Start Date: June 2001
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326807

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Finland
National Public Health Institute
Helsinki, Finland, FIN-00101
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Tony Toneatto, PhD Centre for Addiction and Mental Health
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00326807     History of Changes
Other Study ID Numbers: 095/2001
Study First Received: May 15, 2006
Last Updated: May 15, 2006
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
naltrexone
alcohol
gambling
concurrent

Additional relevant MeSH terms:
Alcoholism
Gambling
Alcohol-Related Disorders
Chemically-Induced Disorders
Impulse Control Disorders
Mental Disorders
Substance-Related Disorders
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014