Back to resultsTreatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray (NALPILO)
Primary Purpose
Gambling, Opioid, Naloxone
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Naloxone hydrochloride 20mg/ml
Sponsored by
About this trial
This is an interventional treatment trial for Gambling focused on measuring antagonist, nasal
Eligibility Criteria
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
Sites / Locations
- National Institute for Heath and Welfare
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
max 8 mg/per day naloxone nasal spray
max 16 mg/per day naloxone nasal spray
Outcomes
Primary Outcome Measures
Adverse events
Diary
Adherence
Case Report Form
Secondary Outcome Measures
Gambling expenditure
Money
Full Information
NCT ID
NCT03223896
First Posted
June 21, 2017
Last Updated
September 10, 2019
Sponsor
Finnish Institute for Health and Welfare
1. Study Identification
Unique Protocol Identification Number
NCT03223896
Brief Title
Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
Acronym
NALPILO
Official Title
Pilot Study: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Finnish Institute for Health and Welfare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling, Opioid, Naloxone, Spray
Keywords
antagonist, nasal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Group A: max 8 mg/per day naloxone nasal spray
Group B: max 16 mg/per day naloxone nasal spray
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
max 8 mg/per day naloxone nasal spray
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
max 16 mg/per day naloxone nasal spray
Intervention Type
Drug
Intervention Name(s)
Naloxone hydrochloride 20mg/ml
Other Intervention Name(s)
Naloxone hyddochlodie
Intervention Description
Nasal spray
Primary Outcome Measure Information:
Title
Adverse events
Description
Diary
Time Frame
8 weeks
Title
Adherence
Description
Case Report Form
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Gambling expenditure
Description
Money
Time Frame
8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu Alho, Prof.
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute for Heath and Welfare
City
Helsinki
ZIP/Postal Code
00271
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36130734
Citation
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.
Results Reference
derived
Links:
URL
https://bmjopen.bmj.com/content/9/8/e023728
Description
Open accès publication on the results
Learn more about this trial
Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
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