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Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

Primary Purpose

Concurrent Alcohol Dependence and Pathological Gambling

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Naltrexone
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concurrent Alcohol Dependence and Pathological Gambling focused on measuring naltrexone, alcohol, gambling, concurrent

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Addiction and Mental Health
  • National Public Health Institute

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 15, 2006
Last Updated
May 15, 2006
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT00326807
Brief Title
Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial of Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concurrent Alcohol Dependence and Pathological Gambling
Keywords
naltrexone, alcohol, gambling, concurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Naltrexone
Primary Outcome Measure Information:
Title
Gambling Urge Questionnaire
Title
Obsessive Compulsive Drinking Scale
Title
Readiness to Change Questionnaire
Title
Frequency of drinking/gambling
Title
Amount of drinking/gambling
Title
Money spent of gambling

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Toneatto, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
Facility Name
National Public Health Institute
City
Helsinki
ZIP/Postal Code
FIN-00101
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16012278
Citation
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. doi: 10.1097/01.jcp.0000172071.81258.04.
Results Reference
background
PubMed Identifier
11093966
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. doi: 10.1093/alcalc/35.6.587.
Results Reference
background
PubMed Identifier
9494755
Citation
Crockford DN, el-Guebaly N. Naltrexone in the treatment of pathological gambling and alcohol dependence. Can J Psychiatry. 1998 Feb;43(1):86. No abstract available.
Results Reference
background
PubMed Identifier
9518986
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. doi: 10.2105/ajph.88.3.467.
Results Reference
background
PubMed Identifier
7690585
Citation
Gianoulakis C. Endogenous opioids and excessive alcohol consumption. J Psychiatry Neurosci. 1993 Jul;18(4):148-56.
Results Reference
background
PubMed Identifier
11386491
Citation
Heinala P, Alho H, Kiianmaa K, Lonnqvist 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. doi: 10.1097/00004714-200106000-00006.
Results Reference
background
PubMed Identifier
36130734
Citation
Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
Results Reference
derived
Links:
URL
http://camh.net
Description
institution link

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Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

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