GamblingPhase 2NALPILONCT03223896
Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
A Phase 2 study testing Naloxone hydrochloride 20mg/ml in people with Gambling and Opioid, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. Brief intervention. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Naloxone hydrochloride 20mg/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 14 Feb 2017to 30 Jun 2017
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- age over 18 years old
- South Oaks Gambling Scale (SOGS) 5 or over points
- possibility to keep a record with phone and send text messages
- fluent in Finnish Language
Who cannot join
- active drug use (specially opioids) current use - drugs screen
- nasal abnormality or mucosal irritability
- hepatitis c virus, kidney insufficiency
- psychosis, unstable mental health, risk suicide (Beck Depression Inventory)
- pregnancy and/or breast feeding
- persons according to Finnish Medical Law 188/1999 §7-10
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. Brief intervention.
Read the detailed description
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. No supportive therapy, but brief self-help booklet. Primary outcomes: adverse events, adherence and drop out analysis. Secondary outcome: gambling expenditure.
- Being tested
- Naloxone hydrochloride 20mg/ml
- Keywords
- antagonist, nasal
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone hydrochloride 20mg/mlDrug
Also called Naloxone hyddochlodie
Nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | max 8 mg/per day naloxone nasal spray Receives: Drug: Naloxone hydrochloride 20mg/ml |
| Group B | Active comparator | max 16 mg/per day naloxone nasal spray Receives: Drug: Naloxone hydrochloride 20mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Diary
Measured: 8 weeks
Adherence
Case Report Form
Measured: 8 weeks
Secondary outcomes (1)
Gambling expenditure
Money
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start14 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group A: max 8 mg/per day naloxone nasal spray Group B: max 16 mg/per day naloxone nasal spray
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hannu Alho, Finnish Institute for Health and Welfare
- Investigators
- Hannu Alho, Prof., Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223896
- Sponsor's protocol ID
- 67016.02.01/2016
- Acronym
- NALPILO
- Status last verified
- Sep 2019
- First submitted
- 21 Jun 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
PubMed 36130734
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
- ClinicalTrials.gov ID
- NCT03223896
- Acronym / sponsor ID
- NALPILO / 67016.02.01/2016
- Keywords
- antagonist, nasal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. Brief intervention.
Detailed description
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. No supportive therapy, but brief self-help booklet. Primary outcomes: adverse events, adherence and drop out analysis. Secondary outcome: gambling expenditure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A: max 8 mg/per day naloxone nasal spray Group B: max 16 mg/per day naloxone nasal spray
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Naloxone hydrochloride 20mg/mlmax 8 mg/per day naloxone nasal spray |
| Group B | Active comparator | Drug: Naloxone hydrochloride 20mg/mlmax 16 mg/per day naloxone nasal spray |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age over 18 years old
- South Oaks Gambling Scale (SOGS) 5 or over points
- possibility to keep a record with phone and send text messages
- fluent in Finnish Language
Key exclusion criteria (6 listed)
- active drug use (specially opioids) current use - drugs screen
- nasal abnormality or mucosal irritability
- hepatitis c virus, kidney insufficiency
- psychosis, unstable mental health, risk suicide (Beck Depression Inventory)
- pregnancy and/or breast feeding
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 |
|---|---|---|
| Naloxone hydrochloride 20mg/mlAlso: Naloxone hyddochlodieNasal spray | Drug | Group A, Group B |
Primary outcome
Adverse events
Time frame: 8 weeks
Diary
Adherence
Time frame: 8 weeks
Case Report Form
1 secondary outcome
Gambling expenditure
Time frame: 8 weeks
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 12 Sep 2019.
- Derived from this study: PubMed 36130734Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
- Open accès publication on the resultsLink provided by the sponsor.
- 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.
Hannu Alho, Prof. principal investigator
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naloxone hydrochloride 20mg/ml in people with Gambling and Opioid, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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 4 inclusion and 6 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 12 Sep 2019. 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 Finland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse events (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03223896, which also lists 1 linked publication.
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 12 Sep 2019.