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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223896
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hannu Alho, National Institute for Health and Welfare, Finland

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.

Condition or disease Intervention/treatment Phase
Gambling Opioid Naloxone Spray Drug: Naloxone hydrochloride 20mg/ml Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Pilot Study: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
max 8 mg/per day naloxone nasal spray
Drug: Naloxone hydrochloride 20mg/ml
Nasal spray
Other Name: Naloxone hyddochlodie

Active Comparator: Group B
max 16 mg/per day naloxone nasal spray
Drug: Naloxone hydrochloride 20mg/ml
Nasal spray
Other Name: Naloxone hyddochlodie




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 8 weeks ]
    Diary

  2. Adherence [ Time Frame: 8 weeks ]
    Case Report Form


Secondary Outcome Measures :
  1. Gambling expenditure [ Time Frame: 8 weeks ]
    Money



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223896


Locations
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Finland
National Institute for Heath and Welfare
Helsinki, Finland, 00271
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Investigators
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Principal Investigator: Hannu Alho, Prof. National Institute for Health and Welfare, Finland

Additional Information:
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Responsible Party: Hannu Alho, Research Professor, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT03223896     History of Changes
Other Study ID Numbers: 67016.02.01/2016
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Hannu Alho, National Institute for Health and Welfare, Finland:
antagonist
nasal
Additional relevant MeSH terms:
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Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents