The Effect of Regular Naltrexone Dosing on Disordered Gamblers

NCT02537197 | Completed Phase 1 DMC

• 1 other identifier: REB15-2025
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Gambling

Outcome Measures

Primary Outcomes (1)

• Abstinence

  No self reports of gambling

  10-14 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Interventions

Naltrexone DRUG

Regular opioid antagonist dosing of disordered gamblers

Also known as: Revia

Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (1)

Opioid Dependency Program

Calgary, Alberta, T2R0X7, Canada

Location

MeSH Terms

Conditions

Gambling

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Darren R Christensen, PhD

  University of Lethbridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre-post design, single treatment group

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: April 1, 2016
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)