Clinical Trial Results:
Feasibility, efficacy and acceptability of injected buprenorphine as treatment for opiate users who persist in injecting illicit heroin through opiate maintenance treatment
Summary
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EudraCT number |
2011-001088-28 |
Trial protocol |
GB |
Global end of trial date |
10 Jan 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Apr 2020
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First version publication date |
23 Apr 2020
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Other versions |
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Summary report(s) |
Cancelled Before Active Statement |
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 |
BRIO
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
South London and Maudsley NHS Foundation Trust
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Sponsor organisation address |
Denmark Hill, London, United Kingdom, SE5 8AZ
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Public contact |
Professor John Strang, South London and Maudsley NHS Foundation Trust, 0044 02078480819, john.strang@kcl.ac.uk
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Scientific contact |
Professor John Strang, South London and Maudsley NHS Foundation Trust, 0044 02078480819, john.strang@kcl.ac.uk
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Sponsor organisation name |
King's College London
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Sponsor organisation address |
The Strand, London, United Kingdom, WC2R 2LS
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Public contact |
Professor John Strang, King's College London, 44 02078480819, john.strang@kcl.ac.uk
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Scientific contact |
Professor John Strang, King's College London, 44 02078480819, john.strang@kcl.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 |
10 Jan 2020
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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 |
10 Jan 2020
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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 trial aims to examine the safety, acceptability, and physiological responses to high dose injectable buprenorphine, for subjects not responding to their current maintenance treatment. The key outcomes are as follows:
- Feasibility, of recruiting and maintaining subjects with a daily injection (IV/IM) of buprenorphine (successful retention outcome defined as 60+ %)
- Reduction or cessation of injecting street heroin (successful outcome defined as 50% of urine tests negative for illicit heroin (i.e. morphine) in weeks 14-26)
- Safety (of daily IV/IM injection of buprenorphine (assessed by observations of IMP administration, laboratory testing, cardio respiratory monitoring, and adverse events)
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Protection of trial subjects |
N/A
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Jan 2020
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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: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
99999
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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 |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial | ||||||
Pre-assignment
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Screening details |
N/A | ||||||
Period 1
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Period 1 title |
Whole trial period (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
N/A open label
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Arms
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Arm title
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Injectable Buprenorphine | ||||||
Arm description |
Subjects will be inducted onto injectable buprenorphine according to the following regime: • Week 1- buprenorphine ampoules 3mg per day • Week 2- buprenorphine ampoules 6mg per day • Week 4- buprenorphine ampoules 9mg per day | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Temgesic
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Investigational medicinal product code |
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Other name |
Buprenorphine
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular and intravenous use
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Dosage and administration details |
9 mg milligram(s) per day
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Investigational medicinal product name |
Suboxone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Sublingual tablet
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Routes of administration |
Sublingual use
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Dosage and administration details |
24 mg milligram(s) per day
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Baseline characteristics reporting groups
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Reporting group title |
Whole trial period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Injectable Buprenorphine
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Reporting group description |
Subjects will be inducted onto injectable buprenorphine according to the following regime: • Week 1- buprenorphine ampoules 3mg per day • Week 2- buprenorphine ampoules 6mg per day • Week 4- buprenorphine ampoules 9mg per day |
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End point title |
feasibility, of recruiting and maintaining (successful retention outcome defined as 60+%) subjects with a daily injection (IV/IM) of buprenorphine [1] | ||||||
End point description |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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End point type |
Primary
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End point timeframe |
N/A
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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 statistical analyses have been specified for this primary end point |
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Notes [2] - N/A |
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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 |
N/A
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
0
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Frequency threshold for reporting non-serious adverse events: 0% | |||
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: No subjects were enrolled in the trial hence results are not available |
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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. | |||
No subjects were enrolled in the trial hence results are not available |