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Trial registered on ANZCTR


Registration number
ACTRN12614000161628
Ethics application status
Approved
Date submitted
31/01/2014
Date registered
10/02/2014
Date last updated
10/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A study exploring the ease with which placebo Suboxone sublingual films can be removed from the mouth after specified times, when administered stacked on top of each other compared to spaced out around the mouth.
Scientific title
An open-label study in Suboxone maintained clients exploring the effect of a stacked versus spaced oral administration of placebo Suboxone sublingual films on the ability to remove all or some of the films from the mouth after specified times.
Secondary ID [1] 284015 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid dependence 291052 0
Condition category
Condition code
Mental Health 291396 291396 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will adopt a repeated measures crossover design with two conditions: film stacking and film spacing. The ease with which the film can be removed from the mouth, following dosing, will be examined. Participants will be provided with placebo film (equivalent in number to their usual dose denomination) and will be asked to try to remove the film following its administration. This will be repeated at various time points: 15 seconds, 30 seconds and 1 minute following administration. Hence, each subject will undergo six different dosing conditions (except for the patients on 1 Suboxone Film where stacking cannot occur, with only 3 conditions). Patients will be asked to estimate the proportion of the film removed on each occasion (none, partial, whole). All sessions will be conducted in a random order design, with 6 subjects required for those receiving one Film, and 12 subjects for each number of multiple films being administered (2,3 or 4), for a total of 42 subjects.

For the stacking conditions, participants will be instructed to administer the film by stacking (i.e. with more than 1 film, the participants will be asked to make the multiple films overlap). For the spaced (side by side) conditions, participants will be instructed to follow specific placement of the films in their mouth (i.e. maximum of 2 films to be placed side-by-side under the tongue and other films buccally on each cheek). Participants will be required to wait 15 minutes between each testing application and have a drink (30ml) of water immediately prior to administering film on each occasion. Hence each session should take approximately 3 hours per participant.
Intervention code [1] 288701 0
Other interventions
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291388 0
Subjective estimate of amount of film able to be removed from the participant's mouth (ie. none, some, all) following sublingual (and buccal where applicable) administration
Timepoint [1] 291388 0
15 seconds, 30 seconds, 1 minute following administration of the last film
Primary outcome [2] 291389 0
Subjective estimate of amount of film able to be removed from the participant's mouth (none, some, all) following administration, when multiple films are stacked sublingually compared to when the films are spaced around the mouth (ie. side by side sublingually and buccally).
Timepoint [2] 291389 0
15 seconds, 30 seconds, 1 minute following administration of the last film
Secondary outcome [1] 306654 0
Nil
Timepoint [1] 306654 0
Nil

Eligibility
Key inclusion criteria
a) In Suboxone Film treatment (2-32mg/day) for at least 1 month
b) Aged 18 years or over
c) Confirmed as not pregnant with urine HCG (for female participants)
d) Able to give written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Participants who, in the opinion of the investigators, cannot fulfil the requirements of the protocol
b) Participants with concomitant severe, untreated medical or psychiatric conditions (as confirmed by treating clinician).

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)
All participants are tested with matched placebo films, not active films. The number of films tested with is consistent with the number of films the participants normally receive with their usual active treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
A total of 42 Suboxone patients will be recruited for this study, with approximately 21 patients targeted for each study site (2 sites in total). This sample size is based upon the number of clients receiving Suboxone film at both sites and provides a representative sample of this subset of clients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288646 0
Commercial sector/Industry
Name [1] 288646 0
Reckitt Benckiser Pty Ltd.
Country [1] 288646 0
Australia
Primary sponsor type
Government body
Name
South Eastern Sydney Local Health District
Address
District Executive Unit
Locked Mail Bag 21
TAREN POINT NSW 2229
Country
Australia
Secondary sponsor category [1] 287357 0
Individual
Name [1] 287357 0
Associate Professor Nicholas Lintzeris
Address [1] 287357 0
c/o The Langton Centre
591 South Dowling Street
Surry Hills
NSW 2010
Country [1] 287357 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Participants will be provided with placebo film (equivalent in number to their usual Suboxone film dose denomination) and will be asked to try to remove the film following its administration sublingually. This will be repeated at various time points following administration (ie. 15 seconds, 30 seconds and 1 minute), under 2 different conditions. That is, the adherence of the film in the mouth (and subsequently ability to remove the film(s)) will be explored when multiple films are stacked as well as when spaced.
Trial website
Trial related presentations / publications
Public notes
Reckitt Benckiser Pty Ltd is funding this study, in part, via award of an untied educational grant to the Chief Investigator.

Contacts
Principal investigator
Name 45950 0
A/Prof Nicholas Linzteris
Address 45950 0
c/o The Langton Centre
591 South Dowling Street
Surry Hills
NSW 2010
Country 45950 0
Australia
Phone 45950 0
+61293328703
Fax 45950 0
Email 45950 0
[email protected]
Contact person for public queries
Name 45951 0
Stefanie Leung
Address 45951 0
c/o The Langton Centre
591 South Dowling Street
Surry Hills
NSW 2010
Country 45951 0
Australia
Phone 45951 0
+61293328794
Fax 45951 0
Email 45951 0
[email protected]
Contact person for scientific queries
Name 45952 0
Stefanie Leung
Address 45952 0
c/o The Langton Centre
591 South Dowling Street
Surry Hills
NSW 2010
Country 45952 0
Australia
Phone 45952 0
+61293328794
Fax 45952 0
Email 45952 0
[email protected]

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.