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

F

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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