Treatment of Gambling Disorder With Fast Acting Opiate An... | NCT03223896

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

NCT03223896

Sponsor

Finnish Institute for Health and Welfare

Status

Completed

Last Update Posted

Sep 12, 2019Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Gambling
Opioid
Naloxone
Spray

Interventions

Naloxone hydrochloride 20mg/ml

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2017Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Jun 21, 2017

First Submission Date that Met QC Criteria

Jul 14, 2017

First Posted Date

Jul 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2019

Last Update Posted Date

Sep 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hannu Alho, Research Professor, Finnish Institute for Health and WelfarePrincipal Investigator

Lead Sponsor

Finnish Institute for Health and WelfareOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	max 8 mg/per day naloxone nasal spray	Drug: Naloxone hydrochloride 20mg/ml
Group B	Active Comparator	max 16 mg/per day naloxone nasal spray	Drug: Naloxone hydrochloride 20mg/ml

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naloxone hydrochloride 20mg/ml	Drug	Nasal spray	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	Diary	8 weeks
Adherence	Case Report Form	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Gambling expenditure	Money	8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hannu Alho, Prof.	Finnish Institute for Health and Welfare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute for Heath and Welfare		Helsinki		00271	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36130734	Derived	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.

ID	Term
D012309	Risk-Taking
D001519	Behavior
D007174	Disruptive, Impulse Control, and Conduct Disorders
D001523	Mental Disorders

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds