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The Effect of Regular Naltrexone Dosing on Disordered Gamblers

Sponsor
University of Calgary (Other)
Overall Status
Completed
CT.gov ID
NCT02537197
Collaborator
Alberta Health services (Other)
35
Enrollment
1
Location
1
Arm
73.8
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pre-post design, single treatment groupPre-post design, single treatment group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Regular Naltrexone Dosing on Disordered Gamblers: An Examination of Neural Activation, Gambling Urges, and Gambling Behaviour
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
May 26, 2022
Actual Study Completion Date :
May 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

Regular Naltrexone dosing (approximately 12 weeks): Initially, participants will be given seven 25mg oral naltrexone (ReVia, Generic Health, or similar) half tablets at intake (days 1-7). The Full dosing regimen will begin if no toxicity issues are present and consists of fourteen 50mg tablets (two per day; 100mg). If required, dosages can be stepped up or down. If adverse symptoms persist (or if gambling symptoms escalates), the participant will be removed from the study and given alternative treatments. Participants will receive the following week's medication at each Calgary Opioid Dependence Program visit. Pill counts will be made at each visit. Physicians will monitor the progress of participants from intake and adjust dosages up or down to control gambling behaviour.

Drug: Naltrexone
Regular opioid antagonist dosing of disordered gamblers
Other Names:
  • Revia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Abstinence [10-14 weeks]

      No self reports of gambling

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Opioid Dependency Program Calgary Alberta Canada T2R0X7

    Sponsors and Collaborators

    • University of Calgary
    • Alberta Health services

    Investigators

    • Principal Investigator: Darren R Christensen, PhD, University of Lethbridge

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Darren Robert Christensen, Principal Investigator, University of Calgary
    ClinicalTrials.gov Identifier:
    NCT02537197
    Other Study ID Numbers:
    • REB15-2025
    First Posted:
    Sep 1, 2015
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Gambling
    Naltrexone

    Study Results

    No Results Posted as of Jun 1, 2022