GamblingPhase 1NCT02537197
The Effect of Regular Naltrexone Dosing on Disordered Gamblers
A Phase 1 study testing Naltrexone in people with Gambling, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gambling
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to 26 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Regular Naltrexone Dosing on Disordered Gamblers: An Examination of Neural Activation, Gambling Urges, and Gambling Behaviour
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.
Read the 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
- Conditions
- Gambling
- Being tested
- Naltrexone
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Revia
Regular opioid antagonist dosing of disordered gamblers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence
No self reports of gambling
Measured: 10-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startApr 2016
- Primary completion26 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post design, single treatment group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Darren Robert Christensen, University of Calgary
- Investigators
- Darren R Christensen, PhD, Principal investigator, University of Lethbridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537197
- Sponsor's protocol ID
- REB15-2025
- Status last verified
- May 2022
- First submitted
- 28 Aug 2015
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regular Naltrexone Dosing on Disordered Gamblers: An Examination of Neural Activation, Gambling Urges, and Gambling Behaviour
- ClinicalTrials.gov ID
- NCT02537197
- Acronym / sponsor ID
- REB15-2025
- Conditions
- Gambling
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- Apr 2016
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post design, single treatment group
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: NaltrexoneRegular 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: ReviaRegular opioid antagonist dosing of disordered gamblers | Drug | Treatment Group |
Primary outcome
Abstinence
Time frame: 10-14 weeks
No self reports of gambling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren R Christensen, PhD principal investigator
University of Lethbridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naltrexone in people with Gambling, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence (time frame: 10-14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.