Clinical Trial Results:
Treating gambling disorder with as
needed administration of intranasal
naloxone: a pilot study to evaluate
acceptability, feasibility and outcomes
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Summary
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EudraCT number |
2016-001828-56 |
Trial protocol |
FI |
Global end of trial date |
30 May 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
28 May 2022
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First version publication date |
28 May 2022
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Other versions |
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Summary report(s) |
NalPilo results |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NalPilo
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Finnish Institute for Health and Welfare
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Sponsor organisation address |
PL 30, Mannerheimintie 166, Helsinki, Finland, 00271
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Public contact |
Sari Castrén, National Institute for Health and Welfare, sari.castren@thl.fi
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Scientific contact |
Sari Castrén, National Institute for Health and Welfare, +358 295248525, sari.castren@thl.fi
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Jan 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 May 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Pilot study, no control group
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Protection of trial subjects |
Close monitor of the subjects well being.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Aug 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
20
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Study participants were recruited by newspaper and online advertisements. Online advertisements were sent to organisations that offer treatment or support services to gamblers seeking help, including Helsinki Gambling Clinic, A-Clinic Foundation (offers treatments for addictions), Peluuri (national gambling helpline) and newspaper advertisements | |||||||||
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Pre-assignment
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Screening details |
The inclusion criteria were last-year gambling problem at prescreening (SOGS ≥5), age >18 years, able to provide written informed consent, criteria met for GD (Diagnostic and Statistical Manual of Mental Disorders, 5th editon (DSM-5))1 as assessed by clinician interview. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||
Blinding implementation details |
The subjects (n=20) were allocated (in an alternating
sequence) by the study physician 1:1 into two groups:
subjects in group A were instructed to take one dose into
one nostril (2mg naloxone), up to four times per day
(max. 8mg/day) with at least 2hours between each dose.
Subjects in group B were instructed to take one dose into
both nostrils (4mg naloxone), up to four times per day
(max. 16mg/day) with at least 2hours between each dose.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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group B | |||||||||
Arm description |
group B were instructed to take one dose into both nostrils (4mg naloxone), up to four times per day (max. 16mg/day) with at least 2hours between each dose. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Naloxone hydrocholoride nasal spay
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray, solution
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Routes of administration |
Intranasal use
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Dosage and administration details |
group A were instructed to take one dose into
one nostril (2mg naloxone), up to four times per day
(max. 8mg/day) with at least 2hours between each dose.
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Arm title
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group A | |||||||||
Arm description |
group A were instructed to take one dose into one nostril (2mg naloxone), up to four times per day (max. 8mg/day) with at least 2hours between each dose. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Naloxone hydrocholoride nasal spay
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Intranasal use
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Dosage and administration details |
group A were instructed to take one dose into
one nostril (2mg naloxone), up to four times per day
(max. 8mg/day) with at least 2hours between each dose.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
Eleven of the 20 subjects were female. The average age was 44 years (n=18) (median=47, range 18–74, Q1=40.25, Q3=55.50, IQR=15.25). Eleven of the subjects were married or cohabited, 9 had only a primary school education and 14 were working. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
group B
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Reporting group description |
group B were instructed to take one dose into both nostrils (4mg naloxone), up to four times per day (max. 16mg/day) with at least 2hours between each dose. | ||
Reporting group title |
group A
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Reporting group description |
group A were instructed to take one dose into one nostril (2mg naloxone), up to four times per day (max. 8mg/day) with at least 2hours between each dose. | ||
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End point title |
SOGS | |||||||||
End point description |
The SOGS (related to gambling behaviours
during the trial Scoring:
of the SOGS screen was as follows: (1) 0=noproblem
with gambling, 1–4 some problems with gambling, 5 or
more=probablepathological gambler
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End point type |
Primary
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End point timeframe |
8 weeks
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Statistical analysis title |
Statistical analysis | |||||||||
Statistical analysis description |
n, 18; t-test, male/female p value; Wilcoxon’s test: age, SOGS (last 12 months) (score: ≥5, probable pathological gambler),
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Comparison groups |
group B v group A
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Number of subjects included in analysis |
18
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | |||||||||
P-value |
< 0.01 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Parameter type |
Wilcoxon | |||||||||
Confidence interval |
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sides |
2-sided
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lower limit |
- | |||||||||
upper limit |
95 | |||||||||
| Notes [1] - SOGS, median; (first and third quartiles) All: 12.00; (10.00, 13.75) group A:12.00; (10.75, 14.25) group B:11.50; (10.0, 13.0) n, 18; t-test, male/female p value; Wilcoxon’s test: age, SOGS (last 12 months) (score: ≥5, probable pathological gambler), |
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End point title |
BDI | |||||||||
End point description |
, BDI (score: 1–9=nodepression; 10–
18=milddepression; 19–29=moderatedepression; 30–63=severedepression)
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End point type |
Secondary
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End point timeframe |
8 weeks
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Subjects were followed up 8 week period for any possible adverse events.
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Adverse event reporting additional description |
Pleas see the published article: Alho et al.
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Assessment type |
Systematic | |||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Group A
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Reporting group description |
18 subjects included in the final analysis 8 in group A and 10 in group B | |||||||||||||||||||||
Reporting group title |
Group B
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Reporting group description |
18 subjects were included in the final analysis 8 group A , 10 group B | |||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Other limitations of our study include lack of a placebo control, a small study size and the use of self-report. The small sample size also prevented us from detecting statistically significant differences between the groups. | |||
