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Pathological GamblingPhase 2NalGambNCT03430180

Effects of Intranasal Naloxone on Gambling Urges and Craving in Gambling Disorder

A Phase 2 study testing Naloxone hydrochloride in people with Pathological Gambling and Gambling Disorder, run by Finnish Institute for Health and Welfare at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Primary objective: *To determine whether treatment with naloxone hydrochloride nasal spray reduces gambling urge symptoms in patients with gambling disorder The secondary objectives of the study are: To determine the effects of naloxone hydrochloride nasal spray on gambling severity, frequency and time, internet use… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Naloxone hydrochloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
1 siteFinland
Study dates
22 Feb 2018to 30 Mar 2020
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 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The Subject must satisfy the following criteria for entry into the study:
  • Aged 18 to 75 years, fluent in Finnish and able to read and understand the patient information sheet
  • Provide written, informed consent prior to any study specific procedure being conducted
  • Gambling problem at pre-screening (SOGS 5 or more points)
  • Moderate (6-7 criteria met) or severe (8-9 criteria met) GD (DSM-5) assessed by clinical interview with Medical Doctor (MD)
  • At least 4 weeks since completion of any other previous treatment for GD
  • At least 8 weeks since completion of any previous treatment with naltrexone or nalmefene
  • Willingness to comply with all study procedures and visit schedules

Who cannot join

  • The Subject will be excluded from the study if any of the following applies:
  • Two weeks or longer abstinence from gambling prior to randomisation
  • Known allergic reactions to naloxone or excipients of IMP and placebo
  • Current use of drugs (opiates, amphetamine, metamphetamine, cocaine, cannabis and benzodiazepines) (as assessed by saliva drug screen, DrugWipe-6)
  • Subject is taking any prohibited medication (opioid analgesics, any medication delivered to the nose)
  • Serious mental illness or severe Depression assessed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Disorders (SCID-I, DSM-5) and the Montgomery and Asberg Depression Rating Scale (MADRS) scores 24 points or more
Show all 18Show fewer
  • Clinically significant risk of suicide (Columbia-Suicide Severity Rating Scale (C-SSRC))
  • Women who are pregnant or breastfeeding at screening or Baseline
  • Serious kidney (P-Creatinine > 110 umol/ml) insufficiency
  • The Subject/patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
  • Liver cirrhosis or liver enzyme elevations, ASAT or ALAT >200 (by blood drop test),
  • Active HCV infection (saliva test, OralQuick-HCV)
  • The person that met the criteria of vulnerable person according to Finnish Medical Research Act No188/1999 7-10§
  • Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile must use effective contraception (either combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD], intrauterine hormone-releasing system [IUS], vasectomised partner, sexual abstinence (only considered an acceptable method of contraception when it is in line with the subjects' usual and preferred lifestyle), combination of male condom with either cap, diaphragm or sponge with spermicide [double barrier methods]), and willing and able to continue contraception for 1 month after the last administration of IMP. Women using oral contraception must have started using it at least 2 months prior to screening. Women are not considered to be of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). Or have had a surgical bilateral oophorectomy (with or without hysterectomy) or bilateral tubal ligation at least six weeks before the screening visit. In case of oophorectomy alone, the reproductive status of the woman should have been confirmed by follow up hormone level assessment.
  • Severe comorbidity (e.g., drug addiction, psychosis, diabetes)
  • Experimental agents must have been discontinued at least 8 weeks prior to screening for a period equivalent to 5 half-lives of the agent (whichever is longer)
  • Any diagnosed nasal conditions including abnormal nasal anatomy, nasal symptoms (i.e. blocked nose, nasal polyps etc.), or having product sprayed in to the nasal cavity prior to drug administration
  • Subject with concurrent disease considered by the investigator to be clinically significant in the context of the study.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • National Institute for Health and Welfare

    Helsinki, Uusimaa, 00270

Other trials in Finland

About this study

Official title: Double-blind, Placebo-controlled Randomised Study on the Efficacy of Naloxone Nasal Spray for the Treatment of Gambling Disorder

Primary objective:

*To determine whether treatment with naloxone hydrochloride nasal spray reduces gambling urge symptoms in patients with gambling disorder

The secondary objectives of the study are:

  • To determine the effects of naloxone hydrochloride nasal spray on gambling severity, frequency and time, internet use, self-efficacy, quality of life, alcohol consumption, depression
  • To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of gambling disorder
Read the detailed description

This is a 12 week, randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of naloxone hydrochloride nasal spray in gambling disorder. Anticipated number of participants are 126.

Treatment Group A: Naloxone hydrochloride 40mg/ml nasal spray Naloxone hydrochloride will be dosed at 4mg / dose (one spray of 0.1ml of the 40mg/ml formulation into one nostril) up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.

Treatment Group B: Placebo nasal spray One spray of 0.1ml of the placebo formulation in one nostril up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.

Safety parameters:

Study Subjects will be asked to report any changes in health via the daily questionnaire. This will be reviewed weekly and at each study Visit (including phone calls) and any adverse events will be documented in the eCRF. Changes in vital signs and outcome of routine blood analyses will be evaluated.

Adverse events (AEs) will be classified using a coding thesaurus (MedDRA).

Primary endpoint: Gambling symptoms (G-SAS) from Baseline to week 12. Gambling symptoms (G-SAS) from Baseline to week 12.

Being tested
Naloxone hydrochloride, Placebo
Medical subject headings
Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naloxone hydrochlorideDrug

    Also called Naloxone 40mg/ml nasal spray when craving to gamble

    Naloxone hydrochloride will be dosed at 4mg / dose (one spray of 0.1ml of the 40mg/ml formulation into one nostril) up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.

  • PlaceboDrug

    Also called Placebo nasal spray with no active ingredients

    One spray of 0.1ml of the placebo formulation in one nostril up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.

Study groups in NCT03430180
Study groupRoleWhat they receive
placebo nasal sprayPlacebo comparatorDrug: placebo nasal spray One spray of 0.1ml of the placebo formulation in one nostril up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.
Receives: Drug: Placebo
Naloxone hydrochloride 40mg/ml nasal sprayActive comparatorNaloxone hydrochloride will be dosed at 4mg / dose (one spray of 0.1ml of the 40mg/ml formulation into one nostril) up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.
Receives: Drug: Naloxone hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Gambling Symptom Assessment Scale (G-SAS) gambling symptom severity and change during the treatment - assessment

    The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. The G-SAS is not a diagnostic or screening instrument. Each 12-item scale has a score ranging from 0 - 4 (adjective anchors for 0 and 4 vary for each item). All items ask for an average symptom based on the past 7 days. Items 1 - 4 can be used to assess changes in craving symptoms. Total score ranges from 0 - 48: extreme = 41 - 48, severe = 31 - 40, moderate = 21 - 30, mild = 8 - 20.

    Measured: Baseline to week, 3, 6, 9 and week 12.

Secondary outcomes (10)

  1. VAS (gambling craving)

    The entire study for an individual participant will last 12 weeks. From baseline to weeks 3,6,9,and 12 craving of gambling will be assessed.

    Measured: Baseline to Week 3, 6, 9 and 12

  2. Gambling severity (PGSI)

    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 severity of gambling will be assessed.

    Measured: Baseline to Week 6 and 12

  3. Gambling severity (DSM-5)

    The entire study for an individual participant will last 12 weeks. From baseline to week 6, and 12 severity of gambling will be assessed.

    Measured: Baseline to Week 6 and 12

  4. Gambling problems (NODS)

    The entire study for an individual participant will last 12 weeks. From baseline to weeks 3,6,9,and 12 level of gambling problems will be assessed.

    Measured: Baseline to Week 3, 6, 9 and 12

  5. Gambling expenditure and frequency

    daily questionnaire / telephone operated (text messages) diary (daily use of sprays, number of doses, gambling expenditure and frequency and possible adverse events) and self-administration of IMP.

    Measured: Baseline to Week 12

  6. Abstinence of gambling (GASS)

    The entire study for an individual participant will last 12 weeks. From baseline to weeks 3,6,9,and 12 abstinence of gambling will be assessed.

    Measured: Baseline to Week 3, 6, 9 and 12

  7. Internet use (Internet disorder scale-9 short form)

    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 internet use will be assessed.

    Measured: Baseline to Week 6 and 12

  8. Quality of life (WHO: EUROHIS-8)

    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 quality of life will be assessed.

    Measured: Baseline to Week 6 and 12

  9. Alcohol consumption (AUDIT)

    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 graving of gambling will be assessed.

    Measured: Baseline to Week 6 and 12

  10. Depression (MADRS)

    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 mood will be assessed.

    Measured: Baseline to Week 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2018
  2. Study start22 Feb 2018
  3. Primary completion30 Aug 2019 (estimated)
  4. Study completion30 Mar 2020 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Treatment Group A: Naloxone hydrochloride 40mg/ml nasal spray Naloxone hydrochloride will be dosed at 4mg / dose (one spray of 0.1ml of the 40mg/ml formulation into one nostril) up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks. One spray of naloxone hydrochloride 40mg/ml nasal spray contains 4 mg naloxone hydrochloride in a formulation of benzalkonium chloride, sodium edetate, sodium chloride, hydrochloric acid and purified water. Treatment Group B: Placebo nasal spray One spray of 0.1ml of the placebo formulation in one nostril up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks. One spray of placebo nasal spray contains benzalkonium chloride, sodium edetate, sodium chloride, hydrochloric acid and purified water
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03430180
Sponsor's protocol ID
NalGamb
Other IDs
2017-001946-93, 2017
Acronym
NalGamb
Status last verified
Jul 2019
First submitted
30 Jan 2018
Last updated
16 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naloxone hydrochloride in people with Pathological Gambling and Gambling Disorder, 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 8 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 16 Jul 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

The Gambling Symptom Assessment Scale (G-SAS) gambling symptom severity and change during the treatment - assessment (time frame: Baseline to week, 3, 6, 9 and week 12.). 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 NCT03430180.

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 16 Jul 2019.

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