Skip to main content
OpenTrials
Completed

NCT Number: NCT02537197

The Effect of Regular Naltrexone Dosing on Disordered Gamblers

This study examines the effect of regular naltrexone dosing on disordered gamblers. Gamblers will also be scanned pre- and post-treatment where we will investigate the functional changes to tasks designed to engage brain region associated with gambling and addiction. These changes will be correlated with treatment outcomes and urge scores.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Opioid Dependency Program

Calgary, Alberta, T2R0X7, Canada

About this study

This study will investigate the effects of regular dosing of naltrexone for the treatment of disordered gambling. It will also examine the changes of neurological functioning to tasks associated with addiction. Converging evidence suggests that disordered gambling shares similarities with substance dependence and disordered alcohol use. Naltrexone is a medication that is used to reduce the cravings and euphoria from opioids and alcohol use and some studies have shown that it also has efficacy as a treatment for problematic gambling. Pilot data suggest the prefrontal cortex is activated for a healthy subject during a delay-discounting task, possibly indicating some consideration of the delayed value of a hypothetical money amount. If discounting rates can be correlated with treatment outcomes and neurological activation, these tasks may provide a new predictive tool for treatment outcome. However, no previous study has examined the neurological changes from pharmacological treatments of gambling. This study will provide data on the differences between pre- and post-treatment of regular naltrexone dosing for disordered gamblers

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-70 years of age.
  • Provide written consent.
  • Evidence of Disordered Gambling (DSM-V; American Psychiatric Association, 2013)
  • Seeking treatment for disordered gambling, referrals, or responding to information about the study presented in the media.
  • Primarily Video Lottery Terminal gamblers (to standardize gamblers and as we are using stimuli in the gambling stimuli task that is similar to video lottery terminals displays so gamblers will be familiar with these images).
  • Attendance at Alberta Health Service Evening Gambling Intensive Program (EGRIP) or similar
  • English speaking

Exclusion criteria

  • Evidence of a current significant medical illness, or unmanaged psychiatric or neurological disorder.
  • Positive urine specimen to drugs of abuse.
  • History of a traumatic brain injury or loss of consciousness (10 minutes or more).
  • History of evidence of claustrophobia
  • Left handed.
  • Any condition or circumstance that prohibit imaging sessions such as metal implants.
  • Contraindications to clinical doses of naltrexone.
  • History or evidence of allergic reactions to naltrexone administration (i.e., rash, itching/swelling, severe dizziness, or trouble breathing).
  • Concurrent use of additional alcohol dependence medication e.g. disulfiram.
  • Evidence of current illicit opioid use
  • Use of medications containing opioids/opiates
  • Uncorrected visual impairment
  • Evidence of brain abnormalities from structural scans
  • Evidence of heart, liver or kidney failure.
  • Failure to attend weekly EGRIP counselling sessions or similar
  • Pregnant

Other Requirements:

  • If sexually active must use contraception
  • Cannot make ovum or sperm donation during study and six-months thereafter

Treatment and study plan

Naltrexone

Drug

Regular opioid antagonist dosing of disordered gamblers

Other names: Revia

Primary outcomes

  1. Abstinence

    Time frame: 10-14 weeks

    No self reports of gambling

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

The Effect of Regular Naltrexone Dosing on Disordered Gamblers: An Examination of Neural Activation, Gambling Urges, and Gambling Behaviour

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Sep 1, 2015
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.