NCT00326807

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2001

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
Last Updated

May 17, 2006

Status Verified

May 1, 2006

First QC Date

May 15, 2006

Last Update Submit

May 15, 2006

Conditions

Concurrent Alcohol Dependence and Pathological Gambling

Keywords

naltrexonealcoholgamblingconcurrent

Outcome Measures

Primary Outcomes (6)

  • Gambling Urge Questionnaire

  • Obsessive Compulsive Drinking Scale

  • Readiness to Change Questionnaire

  • Frequency of drinking/gambling

  • Amount of drinking/gambling

  • Money spent of gambling

Interventions

NaltrexoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

National Public Health Institute

Helsinki, FIN-00101, Finland

Location

Related Publications (7)

  • 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.

    PMID: 16012278BACKGROUND

  • 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.

    PMID: 11093966BACKGROUND

  • 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.

    PMID: 9494755BACKGROUND

  • 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.

    PMID: 9518986BACKGROUND

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

    PMID: 7690585BACKGROUND

  • 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.

    PMID: 11386491BACKGROUND

  • 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.

    PMID: 36130734DERIVED

Related Links

MeSH Terms

Conditions

Gambling

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Tony Toneatto, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

June 1, 2001

Study Completion

June 1, 2004

Last Updated

May 17, 2006

Record last verified: 2006-05

Locations

CA(1)FI(1)