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

NCT03430180 | Unknown Phase 2 DMC FDA Drug

• 2 other identifiers: NalGamb2017-001946-93
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Conditions

Pathological Gambling; Gambling Disorder; Opioid Antagonist; Naloxone

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

• VAS (gambling craving)

  Baseline to Week 3, 6, 9 and 12

• Gambling severity (PGSI)

  Baseline to Week 6 and 12

• Gambling severity (DSM-5)

  Baseline to Week 6 and 12

• Gambling problems (NODS)

  Baseline to Week 3, 6, 9 and 12

• Gambling expenditure and frequency

  Baseline to Week 12

Other Outcomes (7)

• Number and proportion of subjects with adverse events

  Baseline to week 12 - daily

• Assessment of clinical laboratory parameters - Pregnancy test

  Screening to Week 6 and 12

• Assessment of vital signs - blood pressure, pulse, temperature

  Baseline to Week 6 and 12

Study Arms (2)

placebo nasal spray

PLACEBO COMPARATOR

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

Naloxone hydrochloride 40mg/ml nasal spray

ACTIVE COMPARATOR

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

Interventions

Naloxone hydrochloride DRUG

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.

Also known as: Naloxone 40mg/ml nasal spray when craving to gamble

Naloxone hydrochloride 40mg/ml nasal spray

Placebo DRUG

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.

Also known as: Placebo nasal spray with no active ingredients

placebo nasal spray

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Finnish Institute for Health and Welfare: lead

Study Sites (1)

National Institute for Health and Welfare

Helsinki, Uusimaa, 00270, Finland

Location

MeSH Terms

Conditions

Gambling

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Hannu Alho, Prof.

  Finnish Institute for Health and Welfare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research professor

Model Details: 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

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 12, 2018
• Study Start: February 22, 2018
• Primary Completion: August 30, 2019
• Study Completion: March 30, 2020
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)