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The Effect of Regular Naltrexone Dosing on Disordered Gamblers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537197
Recruitment Status : Recruiting
First Posted : September 1, 2015
Last Update Posted : April 9, 2020
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Darren Robert Christensen, University of Calgary

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
Gambling Drug: Naltrexone 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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 : April 2016
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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 Name: Revia




Primary Outcome Measures :
  1. Abstinence [ Time Frame: 10-14 weeks ]
    No self reports of gambling



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537197


Contacts
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Contact: Darren R Christensen, PhD 403-329-5124 darren.christensen@uleth.ca
Contact: Ron Lim, MD 403-297-5118 ronlim1@shaw.ca

Locations
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Canada, Alberta
Opioid Dependency Program Recruiting
Calgary, Alberta, Canada, T2R0X7
Contact: Ron Lim, MD    403-297-5118    ronlim1@shaw.ca   
Contact: Darren Christensen, PhD    403-329-5124    darren.christensen@uleth.ca   
Sponsors and Collaborators
University of Calgary
Alberta Health Services
Investigators
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Principal Investigator: Darren R Christensen, PhD University of Lethbridge
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Responsible Party: Darren Robert Christensen, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT02537197    
Other Study ID Numbers: REB15-2025
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents