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Effects of Intranasal Naloxone on Gambling Urges and Craving in Gambling Disorder (NalGamb)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03430180
Recruitment Status : Enrolling by invitation
First Posted : February 12, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hannu Alho, National Institute for Health and Welfare, Finland

Brief 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, self-efficacy, quality of life, alcohol consumption, depression
  • To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of gambling disorder

Condition or disease Intervention/treatment Phase
Pathological Gambling Gambling Disorder Opioid Antagonist Naloxone Drug: Naloxone hydrochloride Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled Randomised Study on the Efficacy of Naloxone Nasal Spray for the Treatment of Gambling Disorder
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo nasal spray
Drug: 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.
Drug: Placebo
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.
Other Name: Placebo nasal spray with no active ingredients

Active Comparator: 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.
Drug: Naloxone hydrochloride
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.
Other Name: Naloxone 40mg/ml nasal spray when craving to gamble




Primary Outcome Measures :
  1. 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. ]
    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.


Secondary Outcome Measures :
  1. VAS (gambling craving) [ Time Frame: Baseline to Week 3, 6, 9 and 12 ]
    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.

  2. Gambling severity (PGSI) [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 severity of gambling will be assessed.

  3. Gambling severity (DSM-5) [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. From baseline to week 6, and 12 severity of gambling will be assessed.

  4. Gambling problems (NODS) [ Time Frame: Baseline to Week 3, 6, 9 and 12 ]
    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.

  5. Gambling expenditure and frequency [ Time Frame: Baseline to Week 12 ]
    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.

  6. Abstinence of gambling (GASS) [ Time Frame: Baseline to Week 3, 6, 9 and 12 ]
    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.

  7. Internet use (Internet disorder scale-9 short form) [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 internet use will be assessed.

  8. Quality of life (WHO: EUROHIS-8) [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 quality of life will be assessed.

  9. Alcohol consumption (AUDIT) [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 graving of gambling will be assessed.

  10. Depression (MADRS) [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 mood will be assessed.


Other Outcome Measures:
  1. Number and proportion of subjects with adverse events [ Time Frame: Baseline to week 12 - daily ]
    The use of the 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.

  2. Assessment of clinical laboratory parameters - Pregnancy test [ Time Frame: Screening to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. At Screening and week 12 blood pregnancy test and week 6 urine pregnancy test

  3. Assessment of vital signs - blood pressure, pulse, temperature [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. Assessments at baseline, 6 and 12 vital signs ( blood pressure, pulse and temperature) will be assessed.

  4. Assessment of body height [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. Assessments at the baseline, week 6, and week 12. Body height will be assessed.

  5. Assessment of body weight [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. Assessment at baseline, 6, and 12 . Body weight will be assessed.

  6. Assessment and examination of nasal mucosa [ Time Frame: Baseline to Week 6 and 12 ]
    The entire study for an individual participant will last 12 weeks. Assessment at baseline, 6, and 12 nasal mucosa will be assessed using Nasal Irritation Scale (0= normal appearing mucosa, no bleeding to 5= Ulcerated lesions, bleeding with requires medical intervention). Assessment is performed by MD.

  7. Assessment of smell test [ Time Frame: Baseline to Week 12 ]
    The entire study for an individual participant will last 12 weeks. Assessments at baseline and week 12 smell will be assessed.Smell test will be conducted at Baseline and Week 12. NIH Toolbox Odour Identification Test: This validated smell identification test uses 'scratch and sniff' technology, and pictures for the multiple-choice options of 9 common smells. It is intended for a rapid research assessment of olfactory ability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria:

The Subject must satisfy the following criteria for entry into the study:

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

Exclusion Criteria:

  • Exclusion criteria:

The Subject will be excluded from the study if any of the following applies:

  1. Two weeks or longer abstinence from gambling prior to randomisation
  2. Known allergic reactions to naloxone or excipients of IMP and placebo
  3. Current use of drugs (opiates, amphetamine, metamphetamine, cocaine, cannabis and benzodiazepines) (as assessed by saliva drug screen, DrugWipe-6)
  4. Subject is taking any prohibited medication (opioid analgesics, any medication delivered to the nose)
  5. 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
  6. Clinically significant risk of suicide (Columbia-Suicide Severity Rating Scale (C-SSRC))
  7. Women who are pregnant or breastfeeding at screening or Baseline
  8. Serious kidney (P-Creatinine > 110 umol/ml) insufficiency
  9. The Subject/patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
  10. Liver cirrhosis or liver enzyme elevations, ASAT or ALAT >200 (by blood drop test),
  11. Active HCV infection (saliva test, OralQuick-HCV)
  12. The person that met the criteria of vulnerable person according to Finnish Medical Research Act No188/1999 7-10§
  13. 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.
  14. Severe comorbidity (e.g., drug addiction, psychosis, diabetes)
  15. 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)
  16. 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
  17. Subject with concurrent disease considered by the investigator to be clinically significant in the context of the study.

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): NCT03430180


Locations
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Finland
National Institute for Health and Welfare
Helsinki, Uusimaa, Finland, 00270
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Investigators
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Principal Investigator: Hannu Alho, Prof. National Institute for Health and Welfare, Finland

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Responsible Party: Hannu Alho, Research professor, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT03430180    
Other Study ID Numbers: NalGamb
2017-001946-93 ( EudraCT Number )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents