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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03223896
Other study ID # 67016.02.01/2016
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 14, 2017
Est. completion date June 30, 2017

Study information

Verified date September 2019
Source National Institute for Health and Welfare, Finland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 ยง7-10

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Naloxone hydrochloride 20mg/ml
Nasal spray

Locations

Country Name City State
Finland National Institute for Heath and Welfare Helsinki

Sponsors (1)

Lead Sponsor Collaborator
National Institute for Health and Welfare, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events Diary 8 weeks
Primary Adherence Case Report Form 8 weeks
Secondary Gambling expenditure Money 8 weeks
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