Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray (NALPILO)

Finnish Institute for Health and Welfare

Status and phase: Completed; Phase 2

Conditions: Gambling; Naloxone; Opioid; Spray

Treatments: Drug: Naloxone hydrochloride 20mg/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT03223896

67016.02.01/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group A

Active Comparator group

Description:

max 8 mg/per day naloxone nasal spray

Treatment:

Drug: Naloxone hydrochloride 20mg/ml

Group B

Active Comparator group

Description:

max 16 mg/per day naloxone nasal spray

Treatment:

Drug: Naloxone hydrochloride 20mg/ml