Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614001239651
Ethics application status
Approved
Date submitted
5/11/2014
Date registered
26/11/2014
Date last updated
23/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Reduction from 2mg Suboxone film using Buprenorphine only tablets for people in opioid substitution treatment trying to cease treatment.
Scientific title
A Pilot feasibility study of a randomised double blind dose reduction from 2mg Buprenorphine-Naloxone maintenance treatment using Buprenorphine only Temgesic sublingual tablet in a group of people in opioid substitution treatment.
Secondary ID [1] 283995 0
Nil known
Universal Trial Number (UTN)
U1111-1152-7253
Trial acronym
DETOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
opioid dependence 291034 0
Condition category
Condition code
Mental Health 291373 291373 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an exploratory pilot study that aims to examine whether the subjective and objective measures of withdrawal proposed are sensitive enough to discriminate withdrawal, when there is a 0.2, 0.4, 0.6, 0.8 or 1mg reduction from 2mg of Buprenorphine only sublingual tablets (SL; under the tongue), by using the measurements of withdrawal proposed below, in order to provide data for a robust power analysis for a larger study. The trial design involves a randomised 1-way crossover design in three phases over a 21-day period once participants have been transferred from 2mg once daily BNX film to 2mg once daily of Buprenorphine only SL tablets: (1) Phase 1: a baseline phase of Buprenorphine only tablet treatment (2mg equivalent dose) (7 days) followed by (2) Phase 2: a double-blind treatment (experimental) phase (7 days) where participants dose will be reduced to a minimum of 1mg through a combination of active and placebo dosing; and, (3) Phase 3 (7 days): a stabilisation phase where participants will be returned to 2mg Buprenorphine only tablets. Participants will undergo each reduction and will therefore complete Phases 2 and 3 five times during the study (taking 13 weeks to complete). We will monitor adherence by daily saliva testing throughout the experimental phase.
Intervention code [1] 288685 0
Treatment: Drugs
Comparator / control treatment
200 micrograms (0.2mg) Temgesic (Buprenorphine only) sublingual tablets and microcellulose placebo equivelant tablets
Control group
Dose comparison

Outcomes
Primary outcome [1] 291368 0
We aim to examine whether the subjective and objective measures of withdrawal proposed (COWS, SOWS, ARCI WOW191, and pupillometry) are sensitive enough to discriminate withdrawal, when there is a 0.2, 0.4, 0.6, 0.8 or 1mg reduction from 2mg of Buprenorphine only sublingual tablets (SL), in order to provide data for a robust power analysis for a larger study. This is an exploratory study that aims to confirm those measures sensitive enough to enable us to conduct between group differences and to enable calculation of sample size required in future larger study, as such descriptive statistical analysis will be conducted
Timepoint [1] 291368 0
3 months from commencement
Secondary outcome [1] 306614 0
Nil
Timepoint [1] 306614 0
Nil

Eligibility
Key inclusion criteria
a) Expressed desire to end BNX film treatment
b) Currently on BNX film treatment (2mg/day)
c) Aged greater than or equal to 18 years
d) Urine test free of opioids in the previous month
e) Enrolled in BNX film treatment for at least 90 days prior to the study
f) Has not missed more than 2 doses per week for the previous month
g) Negative pregnancy test
h) Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Pregnancy;
j) Participants who cannot fulfil the requirements of the protocol (e.g. requirements for daily attendance) or are in a situation that, in the opinion of the site investigator, may interfere with participation in the study (e.g. pending imprisonment); or
k) Major physical or psychological condition or treatment, judged by clinical team to contraindicate study participation
l) Dependence to other psychoactive substances that require detoxification, including heroin, amphetamines, cocaine, benzodiazepine and/or alcohol (except nicotine)
m) Those who are participating or planning to participate (in the next month) in any other clinical study in which medication(s) are being delivered
n) Those who are taking anticholinergic medications, anticonvulsants, tricyclic antidepressants, phenothiazines, stimulants and sympathomimetics.

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)
Potential participants will be drawn from those who have requested cessation from buprenorphine-naloxone sublingual film treatment. Allocation is concealed with the use of central randomisation by computer by the Trial pharmacist and the use of sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There will be 5 participants and 5 different conditions and the Trial pharmacist will randomly allocate a condition to each participant using an online randomisation program. The Trial pharmacist will be the only person aware of allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is an exploratory study that aims to confirm those measures sensitive enough to enable us to conduct between group differences and to enable calculation of sample size required in future larger study, as such descriptive statistical analysis will be conducted.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2015
Actual
20/10/2015
Date of last participant enrolment
Anticipated
30/04/2016
Actual
20/10/2015
Date of last data collection
Anticipated
30/07/2016
Actual
27/12/2015
Sample size
Target
5
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 288626 0
University
Name [1] 288626 0
University of Adelaide
Country [1] 288626 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Robert Ali
Address
University of Adelaide,
School of Health Sciences,
Department of Pharmacology.
Frome Rd
Adelaide
South Australia 5005
Country
Australia
Secondary sponsor category [1] 288850 0
None
Name [1] 288850 0
Address [1] 288850 0
Country [1] 288850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290484 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 290484 0
The Flats G5 – Rooms 3 and 4
Flinders Drive
Flinders Medical Centre,
Bedford Park SA 5042
Ethics committee country [1] 290484 0
Australia
Date submitted for ethics approval [1] 290484 0
29/01/2014
Approval date [1] 290484 0
24/10/2014
Ethics approval number [1] 290484 0
63.14

Summary
Brief summary
Buprenorphine-Naloxone (BNX) sublingual film is the preferred preparation for buprenorphine substitution treatment of opioid dependence. However, the smallest dose available in the BNX film preparation is 2mg. Experience with buprenorphine has shown that some patients who wish to taper and cease buprenorphine find the transition from 2mg to zero difficult due to severity of withdrawal symptoms, and therefore continue in maintenance treatment (Winstock, Lintzeris, & Lea, 2011). In order to investigate these concerns we propose to use Temgesic sublingual tablets which are Buprenorphine only tablets however they are available in 200 microgram (0.2mg) tablets, and as such allow for smaller dose reductions than Subutex tablets which are only available at 400 microgram (0.4mg).
This pilot study specifically aims to provide subjective and objective measures of withdrawal, when there is a 1mg reduction from 2mg of Temgesic sublingual tablets (SL), by using the measurements of withdrawal proposed below, in order to conduct a power analysis to determine the number of participants required for a larger pilot study.
Trial website
Trial related presentations / publications
Public notes
This is a pilot feasability study

Contacts
Principal investigator
Name 45886 0
A/Prof Robert Ali
Address 45886 0
University of Adelaide
School of Medical Sciences
Department of Pharmacology
Frome Rd
Adelaide
SA 5005
Country 45886 0
Australia
Phone 45886 0
+61 8 8313 8057
Fax 45886 0
+61 8 8313 8059
Email 45886 0
[email protected]
Contact person for public queries
Name 45887 0
Dr Nancy White
Address 45887 0
University of Adelaide
School of Medical Sciences
Department of Pharmacology
Frome Rd
Adelaide
SA 5005
Country 45887 0
Australia
Phone 45887 0
+61 8 8313 8058
Fax 45887 0
+61 8 8313 8059
Email 45887 0
[email protected]
Contact person for scientific queries
Name 45888 0
A/Prof Robert Ali
Address 45888 0
University of Adelaide
School of Medical Sciences
Department of Pharmacology
Frome Rd
Adelaide
SA 5005
Country 45888 0
Australia
Phone 45888 0
+61 8 8313 8057
Fax 45888 0
+61 8 8313 8059
Email 45888 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.