Clinical Trial Results:
A randomised double blind placebo controlled pilot trial of oxytocin efficacy in treating detoxified opioid dependent individuals
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Summary
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EudraCT number |
2014-002708-26 |
Trial protocol |
GB |
Global end of trial date |
06 Oct 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Mar 2019
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First version publication date |
07 Mar 2019
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Other versions |
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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 |
CRC341
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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 |
University of surrey
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Sponsor organisation address |
Stag Hill Campus, Guildford, United Kingdom, GU2 7XH
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Public contact |
RIGO, University of Surrey, +44 01483 689783, RIGO@surrey.ac.uk
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Scientific contact |
RIGO, University of Surrey, +44 01483 689783, RIGO@surrey.ac.uk
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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 |
05 Feb 2019
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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 |
06 Oct 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective will be to investigate the efficacy of oxytocin (Syntocinon) in retaining post-detoxification opioid (e.g. heroin) dependent individuals in inpatient rehabilitation programme and in preventing relapse to opioids (e.g. heroin) or other drug use.
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Protection of trial subjects |
No participants completed the protocol of this study, the study was terminated due to IMP going out of date and no funds for new IMP
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Background therapy |
n/a | ||
Evidence for comparator |
n/a | ||
Actual start date of recruitment |
06 Apr 2015
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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 |
United Kingdom: 3
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Worldwide total number of subjects |
3
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EEA total number of subjects |
3
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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) |
3
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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 |
Only one participant was recruited and dosed, they left the trial before they could complete. Recruitment was difficult due tot he nature of the participants condition, and overly burdensome protocol and strict exclusion criteria. | |||||||||
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Pre-assignment
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Screening details |
n/a | |||||||||
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Period 1
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Period 1 title |
Active phase (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor | |||||||||
Blinding implementation details |
Blinding was carried out by a statistician, sealed in envelopes and stored with the unblended monitor.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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placebo arm | |||||||||
Arm description |
Placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
placebo
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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 |
Nasal use
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Dosage and administration details |
No active sunstance one spray into the nasal cavity
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Arm title
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IMP Arm | |||||||||
Arm description |
Subjects allocated into IMP arm | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Syntocin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal drops, suspension
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Routes of administration |
Nasal use
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Dosage and administration details |
5UI sprayed directly into the nasal cavity
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End points reporting groups
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Reporting group title |
placebo arm
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Reporting group description |
Placebo | ||
Reporting group title |
IMP Arm
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Reporting group description |
Subjects allocated into IMP arm | ||
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End point title |
reduction in lapsinginto opiod dependency [1] | |||||||||
End point description |
it was hoped participants would not return to opioid dependency
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End point type |
Primary
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End point timeframe |
ongoing
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No Participants completed the trial. No statistical analysis was possible. |
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| Notes [2] - no participants completed the protocol [3] - No Participants completed the protocol |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
6 months
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Adverse event reporting additional description |
n/a no subjects passed the whole protocol. No SAEs
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
21
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| Frequency threshold for reporting non-serious adverse events: 1% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There was no adverse events as we had no participants last more than one day in the trial. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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01 Mar 2015 |
Change of IMP supplier |
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01 Nov 2015 |
New IMP Supplier |
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01 Sep 2016 |
Removal of saliva cortisol measurement |
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01 May 2017 |
Change in inclusion criteria, participant added who are currently taking antidepressants - previously excluded. |
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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. | |||
| No Participant completed the trial so no data was attained | |||
