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The Effect of Regular Naltrexone Dosing on Disordered Gamblers

Primary Purpose

Gambling

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Naltrexone
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Opioid Dependency Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Abstinence
No self reports of gambling

Secondary Outcome Measures

Full Information

First Posted
August 28, 2015
Last Updated
May 26, 2022
Sponsor
University of Calgary
Collaborators
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT02537197
Brief Title
The Effect of Regular Naltrexone Dosing on Disordered Gamblers
Official Title
The Effect of Regular Naltrexone Dosing on Disordered Gamblers: An Examination of Neural Activation, Gambling Urges, and Gambling Behaviour
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 26, 2022 (Actual)
Study Completion Date
May 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Pre-post design, single treatment group
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Revia
Intervention Description
Regular opioid antagonist dosing of disordered gamblers
Primary Outcome Measure Information:
Title
Abstinence
Description
No self reports of gambling
Time Frame
10-14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren R Christensen, PhD
Organizational Affiliation
University of Lethbridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Opioid Dependency Program
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2R0X7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Regular Naltrexone Dosing on Disordered Gamblers

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