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The Effect of Regular Naltrexone Dosing on Disordered Gamblers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02537197
Enrollment
35
Registered
2015-09-01
Start date
2016-04-30
Completion date
2022-05-26
Last updated
2022-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gambling

Brief summary

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.

Detailed description

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

Interventions

DRUGNaltrexone

Regular opioid antagonist dosing of disordered gamblers

Sponsors

Alberta Health services
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pre-post design, single treatment group

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Abstinence10-14 weeksNo self reports of gambling

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026