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Trial registered on ANZCTR


Registration number
ACTRN12611000545965
Ethics application status
Approved
Date submitted
12/05/2011
Date registered
30/05/2011
Date last updated
30/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial to assess the acceptability of a switch from Suboxone Registered Trademark (R) sublingual tablets to Suboxone(R) sublingual film.
Scientific title
A randomised controlled trial to assess the acceptability of a switch from Suboxone(R) sublingual tablets to Suboxone(R) sublingual film among patients participating in an opioid treatment program (OTP).
Secondary ID [1] 262173 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid dependency 257458 0
Opioid substitution therapy for opioid dependence 265847 0
Condition category
Condition code
Mental Health 257605 257605 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-randomisation
All participants receive their usual daily dose of Suboxone(R) as soluble buprenorphine/naloxone tablets (7 days open label)

Post-randomisation
Randomised to one of two arms (intervention or comparator).
Arm 1: Soluble sublingual buprenorphine/naloxone films at their usual daily dose (10 days double-blind double dummy placebo controlled followed by 14 days open label)

NB. The placebo for Arm 1 were matched soluble sublingual inactive films. If patients were randomised to Arm 1, they would receive both film and tablets in the double-blind phase, with the film being active and the tablets placebo. Conversely, if randomised to Arm 2, they would receive both film and tablets in the double-blind phase, with the tablets being active and the film placebo. Patients received only ONE active preparation at all times.
Intervention code [1] 256550 0
Treatment: Drugs
Comparator / control treatment
Pre-randomisation
All participants receive their usual daily dose of Suboxone(R) as soluble buprenorphine/naloxone tablets (7 days open label)

Post-randomisation
Randomised to one of two arms (intervention or comparator).
Arm 2: Soluble buprenorphine/naloxone tablets at their usual daily dose (10 days double-blind double dummy placebo controlled followed by 14 days open label)

NB. The placebo for Arm 1 were matched soluble sublingual inactive films. If patients were randomised to Arm 1, they would receive both film and tablets in the double-blind phase, with the film being active and the tablets placebo. Conversely, if randomised to Arm 2, they would receive both film and tablets in the double-blind phase, with the tablets being active and the film placebo. Patients received only ONE active preparation at all times.
Control group
Active

Outcomes
Primary outcome [1] 266741 0
Patient preferences and ratings of ease/convenience of use between Suboxone sublingual film and Suboxone tablets as measured by likert and visual analogue scales
Timepoint [1] 266741 0
Measured 31 days after randomisation.
Primary outcome [2] 266742 0
Dose effects of Suboxone sublingual film compared to Suboxone tablets as measured by visual analogue scales, as well as the subjective opiate withdrawal scale (SOWS) and the objective opiate withdrawal scale (OOWS)
Timepoint [2] 266742 0
Measured on day 0, day 5, day 17, day 24 and day 31 after randomisation.
Primary outcome [3] 266743 0
Adverse events on Suboxone sublingual film compared to Suboxone tablets using a self-report questionnaire. Examples of such adverse events are constipation, dry mouth and insomnia.
Timepoint [3] 266743 0
Measured on day 0, day 5, day 17, day 24 and day 31 after randomisation.
Secondary outcome [1] 276293 0
Ease of removing Suboxone sublingual film from the mouth post-administration. This task used matched placebo sublingual films, and the participants was asked whether all, some or none of the film could be removed after (i) 30 seconds and (ii) 1 minute in the mouth.
Timepoint [1] 276293 0
Measured on 31 days after randomisation
Secondary outcome [2] 276294 0
Time taken to dispense Suboxone sublingual film compared to Suboxone tablets. Participants were asked to indicate when they could no longer feel the tablet or film in their mouth, and the time from when it was administered was recorded in seconds.
Timepoint [2] 276294 0
Measured on 3 separate occasions during the final 14 days of the trial.

Eligibility
Key inclusion criteria
a) Opioid dependence according to the DSM IV-TR criteria,
b) Buprenorphine or buprenorphine/naloxone treatment (4-32mg/day) for at least 3 months
c) Stable Suboxone dose for at least 30 days.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Dependence to other psychoactive substances
b) Patients with concomitant severe, untreated medical or psychiatric conditions
c) Patients who cannot fulfil the requirements of the protocol (e.g. requirements for attendance)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265066 0
Commercial sector/Industry
Name [1] 265066 0
Reckitt Benckiser
Country [1] 265066 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Nicholas Lintzeris
Address
c/o The Langton Centre
591 South Dowling Street
Surry Hills
NSW 2010
Country
Australia
Secondary sponsor category [1] 264158 0
Individual
Name [1] 264158 0
Associate Professor Robert Ali
Address [1] 264158 0
Discipline of Pharmacology
The University of Adelaide
SA 5005
Country [1] 264158 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267059 0
Sydney South West Area Health Service (SSWAHS) Human Research Ethics Committee (RPA Zone)
Ethics committee address [1] 267059 0
Ethics committee country [1] 267059 0
Australia
Date submitted for ethics approval [1] 267059 0
Approval date [1] 267059 0
Ethics approval number [1] 267059 0
HREC/10/RPAH/7

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

Contacts
Principal investigator
Name 31217 0
Address 31217 0
Country 31217 0
Phone 31217 0
Fax 31217 0
Email 31217 0
Contact person for public queries
Name 14464 0
Stefanie Leung
Address 14464 0
c/o The Langton Centre
591 South Dowling Street
Surry Hills
NSW 2010
Country 14464 0
Australia
Phone 14464 0
+61295158972
Fax 14464 0
Email 14464 0
stefanie.leung@sydney.edu.au
Contact person for scientific queries
Name 5392 0
Stefanie Leung
Address 5392 0
c/o The Langton Centre
591 South Dowling Street
Surry Hills
NSW 2010
Country 5392 0
Australia
Phone 5392 0
+61295158972
Fax 5392 0
Email 5392 0
stefanie.leung@sydney.edu.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.