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

September 10, 2019 updated by: Hannu Alho, Finnish Institute for Health and Welfare

Pilot Study: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00271
        • National Institute for Heath and Welfare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
max 8 mg/per day naloxone nasal spray
Drug: Naloxone hydrochloride 20mg/ml
Nasal spray
Other Names:
  • Naloxone hyddochlodie
ACTIVE_COMPARATOR: Group B
max 16 mg/per day naloxone nasal spray
Drug: Naloxone hydrochloride 20mg/ml
Nasal spray
Other Names:
  • Naloxone hyddochlodie

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gambling expenditure
Time Frame: 8 weeks
Money
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Institute for Health and Welfare

Investigators

  • Principal Investigator: Hannu Alho, Prof., Finnish Institute for Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 14, 2017

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

June 30, 2017

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (ACTUAL)

July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67016.02.01/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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