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Trial registered on ANZCTR


Registration number
ACTRN12617000039381
Ethics application status
Approved
Date submitted
6/01/2017
Date registered
10/01/2017
Date last updated
5/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of flumazenil infusion in the treatment of alcohol withdrawal
Scientific title
The role of flumazenil infusion in the treatment of alcohol withdrawal
Secondary ID [1] 290275 0
Nil known
Universal Trial Number (UTN)
U1111-1188-3703
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol withdrawal syndrome 300508 0
Condition category
Condition code
Mental Health 300365 300365 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double-blind placebo-controlled randomised clinical trial of a 96-hour continuous subcutaneous infusion of flumazenil 16 mg (approx. 167mcg/hr) for the treatment of alcohol withdrawal syndrome.
Arm 1: 96-hour continuous subcutaneous infusion of flumazenil 16 mg (approx. 167mcg/hr) plus oral diazepam 10-20 mg hourly as required. The requirement for diazepam will be determined by patient carers using the CIWA-Ar scale as follows; no diazepam to be given for a score less than or equal to 7, diazepam 10 mg for a score between 8 and 14 inclusive and diazepam 20 mg for a score of 15 or higher.
Intervention code [1] 296079 0
Treatment: Drugs
Comparator / control treatment
Arm 2: 96-hour continuous subcutaneous infusion of flumazenil 16 mg (approx. 167mcg/hr) with oral placebo capsules as required
Arm 3: 96-hour continuous subcutaneous placebo infusion with oral diazepam 10-20 mg hourly as required
The requirement for diazepam will be determined by patient carers using the CIWA-Ar scale as follows; no diazepam to be given for a score less than or equal to 7, diazepam 10 mg for a score between 8 and 14 inclusive and diazepam 20 mg for a score of 15 or higher.
Placebo subcutaneous infusions contain 0.9% sodium chloride saline and placebo oral capsules contain microcrystalline cellulose.
Control group
Active

Outcomes
Primary outcome [1] 299827 0
Withdrawal symptom severity throughout alcohol detoxification, as assessed by CIWA-Ar.
Timepoint [1] 299827 0
Days 1, 2, 3 and 4 of treatment.
Secondary outcome [1] 328219 0
Length of time abstinent from alcohol after commencement of treatment, based on participant self-report.
Timepoint [1] 328219 0
12 weeks after the commencement of treatment.
Secondary outcome [2] 328220 0
Quantity of alcohol consumed post-treatment, based on participant self-report.
Timepoint [2] 328220 0
12 weeks after the commencement of treatment
Secondary outcome [3] 328221 0
Craving for alcohol during withdrawal, as assessed by the Brief Substance Craving Scale.
Timepoint [3] 328221 0
Days 1, 2, 3 and 4 of alcohol withdrawal treatment.
Secondary outcome [4] 328222 0
Post-alcohol withdrawal anxiety, as assessed by Spielberger's State and Trait Anxiety Index.
Timepoint [4] 328222 0
1, 2, 4, 8 and 12 weeks after the commencement of treatment
Secondary outcome [5] 328223 0
Post-alcohol withdrawal sleep quality, as assessed by a questionnaire consisting of 6 4-point NRS questions.
Timepoint [5] 328223 0
1, 2, 4, 8 and 12 weeks after the commencement of treatment.
Secondary outcome [6] 328226 0
Tissue reactivity at the infusion site, as assessed by an investigator using a 4-point NRS.
Timepoint [6] 328226 0
Days 1, 2, 3 and 4 of treatment.

Eligibility
Key inclusion criteria
Participants will be patients of Fresh Start Recovery Programme who are receiving naltrexone implant treatment for problematic alcohol use. To be included in the study, patients must score 22 or higher on the Alcohol Dependence Scale (Skinner & Allen, 1982) and have the desire to cease alcohol consumption.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they suffer epilepsy or have a history of seizures or fitting, are pregnant or are breastfeeding, are co-dependent on benzodiazepines, are under 18 years of age or are unable or unwilling to provide informed consent.

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)
Allocation will be concealed by using identical packaging for placebo and active treatments which are pre-labelled by an appointed person who does not have any other involvement in the trial or any contact with clinic patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple blocked randomisation with randomly selected block sizes was used. The randomisation sequence was created using an online randomisation service,
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size was determined by power calculations which were based on CIWA-Ar scores previously reported by studies of alcohol withdrawal treatment using diazepam and flumazenil.

Data from the study will be analysed using SPSS. 1-way between-subjects ANOVA with Tukey post-hoc analysis will be used to compare benzodiazepine/placebo consumption, CIWA-Ar scores, alcohol craving, sleep quality and anxiety between the three treatment groups at each time point and to compare differences across the duration of treatment and follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/02/2016
Date of last participant enrolment
Anticipated
1/10/2018
Actual
Date of last data collection
Anticipated
1/01/2019
Actual
Sample size
Target
45
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 14434 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 294649 0
Commercial sector/Industry
Name [1] 294649 0
Go Medical Industries Pty Ltd
Country [1] 294649 0
Australia
Funding source category [2] 294651 0
University
Name [2] 294651 0
The University of Western Australia
Country [2] 294651 0
Australia
Funding source category [3] 294652 0
Other
Name [3] 294652 0
Fresh Start Recovery Programme
Country [3] 294652 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Go Medical Industries Pty Ltd
Address
200 Churchill Ave, Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 293511 0
None
Name [1] 293511 0
Address [1] 293511 0
Country [1] 293511 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296091 0
Southcity Medical Centre Human Research Ethics Committee
Ethics committee address [1] 296091 0
Ethics committee country [1] 296091 0
Australia
Date submitted for ethics approval [1] 296091 0
24/03/2015
Approval date [1] 296091 0
08/09/2015
Ethics approval number [1] 296091 0
001/2015

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

Contacts
Principal investigator
Name 69482 0
A/Prof George O'Neil
Address 69482 0
Fresh Start Recovery Programme
65 Townshend Rd, Subiaco WA 6008
Country 69482 0
Australia
Phone 69482 0
+61 8 9381 1333
Fax 69482 0
Email 69482 0
[email protected]
Contact person for public queries
Name 69483 0
George O'Neil
Address 69483 0
Fresh Start Recovery Programme
65 Townshend Rd, Subiaco WA 6008
Country 69483 0
Australia
Phone 69483 0
+61 8 9381 1333
Fax 69483 0
Email 69483 0
[email protected]
Contact person for scientific queries
Name 69484 0
George O'Neil
Address 69484 0
Fresh Start Recovery Programme
65 Townshend Rd, Subiaco WA 6008
Country 69484 0
Australia
Phone 69484 0
+61 8 9381 1333
Fax 69484 0
Email 69484 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

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