Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
NALPILO
Pilot Study: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2017
CompletedFirst Submitted
Initial submission to the registry
June 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedSeptember 12, 2019
September 1, 2019
5 months
June 21, 2017
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse events
Diary
8 weeks
Adherence
Case Report Form
8 weeks
Secondary Outcomes (1)
Gambling expenditure
8 weeks
Study Arms (2)
Group A
ACTIVE COMPARATORmax 8 mg/per day naloxone nasal spray
Group B
ACTIVE COMPARATORmax 16 mg/per day naloxone nasal spray
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute for Heath and Welfare
Helsinki, 00271, Finland
Related Publications (1)
Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
PMID: 36130734DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hannu Alho, Prof.
Finnish Institute for Health and Welfare
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
June 21, 2017
First Posted
July 21, 2017
Study Start
February 14, 2017
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
September 12, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share