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

Finnish Institute for Health and Welfare20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gambling Opioid Naloxone Spray

Interventions

Naloxone hydrochloride 20mg/mlDRUG

Nasal spray

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Institute for Heath and Welfare

Helsinki, Finland

Outcomes

Primary Outcomes

Adverse events

Diary

Time frame: 8 weeks

Adherence

Case Report Form

Time frame: 8 weeks

Secondary Outcomes

Gambling expenditure

Money

Time frame: 8 weeks

Data from ClinicalTrials.gov

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