Concurrent Alcohol Dependence and Pathological GamblingNCT00326807
Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling
A study testing Naltrexone in people with Concurrent Alcohol Dependence and Pathological Gambling, run by Centre for Addiction and Mental Health at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Concurrent Alcohol Dependence and Pathological Gambling
- What is being tested?
- Naltrexone
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2001to Jun 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Inability to read or write English.
- Poor motivation to change alcohol or gambling behavior
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of 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.
Read the 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.
- Being tested
- Naltrexone
- Keywords
- naltrexone, alcohol, gambling, concurrent
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Gambling Urge Questionnaire
Obsessive Compulsive Drinking Scale
Readiness to Change Questionnaire
Frequency of drinking/gambling
Amount of drinking/gambling
Money spent of gambling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startJun 2001
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Concurrent Alcohol Dependence and Pathological GamblingStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Investigators
- Tony Toneatto, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326807
- Sponsor's protocol ID
- 095/2001
- Status last verified
- May 2006
- First submitted
- 15 May 2006
- Last updated
- 17 May 2006
- Results posted
- No
Publications
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.
PubMed 16012278Chick 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.
PubMed 11093966Crockford 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.
PubMed 9494755Feigelman 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.
PubMed 9518986Gianoulakis C. Endogenous opioids and excessive alcohol consumption. J Psychiatry Neurosci. 1993 Jul;18(4):148-56.
PubMed 7690585Heinala 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.
PubMed 11386491Dowling 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.
PubMed 36130734
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling
- ClinicalTrials.gov ID
- NCT00326807
- Acronym / sponsor ID
- 095/2001
- Keywords
- naltrexone, alcohol, gambling, concurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jun 2001
- Study completion
- Jun 2004
- First posted
- 17 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone | Drug | – |
Primary outcome
Gambling Urge Questionnaire
Obsessive Compulsive Drinking Scale
Readiness to Change Questionnaire
Frequency of drinking/gambling
Amount of drinking/gambling
Money spent of gambling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2006.
- Background: PubMed 16012278Anton 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.
- Background: PubMed 11093966Chick 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.
- Background: PubMed 9494755Crockford 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.
- Background: PubMed 9518986Feigelman 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.
- Background: PubMed 7690585Gianoulakis C. Endogenous opioids and excessive alcohol consumption. J Psychiatry Neurosci. 1993 Jul;18(4):148-56.
- Background: PubMed 11386491Heinala 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.
- Derived from this study: PubMed 36130734Dowling 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.
- institution linkLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Toneatto, PhD principal investigator
Centre for Addiction and Mental Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone in people with Concurrent Alcohol Dependence and Pathological Gambling, run by Centre for Addiction and Mental Health at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gambling Urge Questionnaire. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00326807, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2006.