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Completed

NCT Number: NCT03223896

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

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.

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Key information

Conditions

Gambling Behavior Disruptive, Impulse Control, and Conduct Disorders Mental Disorders Naloxone Opioid Risk-Taking Spray

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute for Heath and Welfare

Helsinki, 00271, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naloxone hydrochloride 20mg/ml

Drug

Nasal spray

Other names: Naloxone hyddochlodie

Primary outcomes

  1. Adverse events

    Time frame: 8 weeks

    Diary

  2. Adherence

    Time frame: 8 weeks

    Case Report Form

Secondary outcomes

  1. Gambling expenditure

    Time frame: 8 weeks

    Money

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Registry information

Official study title

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

Acronym: NALPILO

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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