Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000058471
Ethics application status
Approved
Date submitted
22/08/2006
Date registered
18/01/2007
Date last updated
18/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acceptability, safety and tolerability of combined methadone-naloxone - Intra muscular (IM) challenge
Scientific title
Does intra muscular methadone nalxone in a 50:1 ratio precipitate withdrawal among opioid dependent individuals
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid dependence 1552 0
Condition category
Condition code
Mental Health 1651 1651 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receive 3 injections:
IM Saline adminsitered at baseline, 10mg/.2mg methadone naloxone administered IM at 20 minutes and if no objective signs of withdrawal are observed at 50 minutes, a further 20mg/.4mg methadone naloxone administered IM.
Intervention code [1] 1320 0
Other interventions
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2278 0
Opioid Withdrawal Score (OOWS)
Timepoint [1] 2278 0
At 5, 15, 30 and 60 minutes
Primary outcome [2] 2279 0
Pupil size (mm)
Timepoint [2] 2279 0
At 5, 15, 30 and 60 minutes
Secondary outcome [1] 3985 0
Subjective Opioid Withdrawal Score (SOWS)
Timepoint [1] 3985 0
At 5, 15, 30 and 60 minutes
Secondary outcome [2] 3986 0
Profile of Mood States (POMS) Score
Timepoint [2] 3986 0
At 5, 15, 30 and 60 minutes
Secondary outcome [3] 3987 0
Morphine Benzedrine Group (MBG) Score
Timepoint [3] 3987 0
At 5, 15, 30 and 60 minutes

Eligibility
Key inclusion criteria
Opioid dependent; in treatment for >2mths; on methadone dose of >20mg; stabilised on current dose for >4 weeks; Able to provide voluntary informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Considered unwilling, unable or unlikely to comply with the study protocol;Lactating and pregnant women; Active psychotic illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1798 0
Commercial sector/Industry
Name [1] 1798 0
Biomed Pty Ltd
Country [1] 1798 0
Primary sponsor type
Hospital
Name
The Langton Centre
Address
Country
Australia
Secondary sponsor category [1] 1617 0
Commercial sector/Industry
Name [1] 1617 0
Biomed Pty Ltd
Address [1] 1617 0
Country [1] 1617 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3359 0
The Langton Centre approved By SESIAHS HREC
Ethics committee address [1] 3359 0
Ethics committee country [1] 3359 0
Australia
Date submitted for ethics approval [1] 3359 0
Approval date [1] 3359 0
25/10/2005
Ethics approval number [1] 3359 0
05/270

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27927 0
Address 27927 0
Country 27927 0
Phone 27927 0
Fax 27927 0
Email 27927 0
Contact person for public queries
Name 10509 0
Associate Professor James Bell
Address 10509 0
591 South Dowling Street
Surry Hills NSW 2010
Country 10509 0
Australia
Phone 10509 0
+61 2 93328777
Fax 10509 0
+61 2 93328700
Email 10509 0
James.Bell@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 1437 0
Anni Ryan
Address 1437 0
591 South Dowling Street
Surry Hills NSW 2010
Country 1437 0
Australia
Phone 1437 0
+61 2 93328777
Fax 1437 0
+61 2 93328700
Email 1437 0
Anni.Ryan@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.