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

Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling



Sponsors


Source

Centre for Addiction and Mental Health

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.

Overall Status

Completed

Start Date

2001-06-01

Completion Date

2004-06-01

Primary Completion Date

N/A

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Gambling Urge Questionnaire
Obsessive Compulsive Drinking Scale
Readiness to Change Questionnaire
Frequency of drinking/gambling
Amount of drinking/gambling
Money spent of gambling

Enrollment

50

Condition


Intervention

Intervention Type

Drug

Intervention Name



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

Gender

All

Minimum Age

18 Years

Maximum Age

65 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Tony Toneatto, PhD
Principal Investigator
Centre for Addiction and Mental Health

Location

Facility

Centre for Addiction and Mental Health
Toronto Ontario M5S 2S1 Canada
National Public Health Institute
Helsinki FIN-00101 Finland

Location Countries

Country

Canada

Finland



Verification Date

2006-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Keywords


Has Expanded Access

No

Condition Browse


Intervention Browse

Mesh Term

Ethanol

Naltrexone



Firstreceived Results Date

N/A

Reference

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.

PMID

16012278


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.

PMID

11093966


Citation

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

PMID

9494755


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.

PMID

9518986


Citation

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

PMID

7690585


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.

PMID

11386491



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Primary Purpose

Treatment

Masking

Double


Study First Submitted

May 15, 2006

Study First Submitted Qc

May 15, 2006

Study First Posted

May 17, 2006

Last Update Submitted

May 15, 2006

Last Update Submitted Qc

May 15, 2006

Last Update Posted

May 17, 2006


ClinicalTrials.gov processed this data on August 22, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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