Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000424909
Ethics application status
Approved
Date submitted
16/03/2020
Date registered
30/03/2020
Date last updated
30/03/2020
Date data sharing statement initially provided
30/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing for phosphatidylethanol (PEth) in red blood cells as a measure of past alcohol exposure.
Scientific title
Testing for phosphatidylethanol (PEth) in red blood cells as a measure of past alcohol exposure in normal human volunteers.
Secondary ID [1] 300624 0
None
Universal Trial Number (UTN)
U1111-1248-6407
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption 316389 0
Condition category
Condition code
Diet and Nutrition 314651 314651 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in "Study 2" of this trial will voluntarily abstain from alcohol continuously for 4 weeks, over which time five blood specimens will be collected to track the disappearance of phosphatidylethanol from blood. The blood specimens will be collected at baseline and at 7 (+/- 1), 14 (+/- 1), 21 (+/- 1) and 28 (+/- 1) days. That is the only intervention in this study.
There is no intervention in other part of the trial ("Study 1"). There is no drug administration in any arm of the trial. Participants will not receive any other non-drug intervention. Participants will be going about their normal daily lives throughout their participation in the trial, except for the need to attend for initial screening checking and for blood collections. The importance of completing the drinking diary accurately is emphasised in the patient information and consent process for Study 1. The importance of reporting deviations from abstinence is also emphasised in the patient information and consent process for Study 2. Adjunctive methods of checking participant adherence, such as tablet counts, cannot be applied where dosing (alcohol intake) is at the participant's discretion.
Intervention code [1] 316938 0
Lifestyle
Comparator / control treatment
One study arm (Study 1, Substudy a) measures erythrocyte phosphatidylethanol concentrations in habitual non-drinkers of alcohol (one visit for data and blood collection) and in people who do customarily drink alcohol (two visits for data and blood collection, a week apart).
A second arm of Study 1 (Substudy b) measures erythrocyte phosphatidylethanol concentrations in drinkers of alcohol, who are keeping a quantitative diary of alcohol consumption. Participants will choose the arm of Study 1 that they want to join, The dependence of phosphatidylethanol concentration on alcohol consumption and demographic and health data will be tested in statistical analysis of all Study 1 participants. There is a "Dose comparison" involved in the analysis of Study 1 (both subgroups), determining relationships between diarised alcohol consumption (including nil consumption in non-drinker subgroup of Study 1a) and measured phosphatidylethanol concentration.
A third arm (Study 2) measures erythrocyte phosphatidylethanol concentrations in another group of customary alcohol drinkers, before and during a four-week period of voluntary alcohol abstinence. Entry into this study will be by participant choice. The disappearance of phosphatidylethanol from blood during alcohol abstinence will be tracked. All participants will be regarded as subject to the same intervention. Study 2 follows a single group over time. All are subject to the same intervention, that is, voluntarily going from regular drinkers to abstainers for a month. Comparing phosphatidylethanol between the still-drinking state with the non-drinking state is a within-subject dose comparison, The outcome measure (phosphatidylethanol) is time-dependent as well as dose-dependent. Time dependence has to be properly described for the test to become useful in estimating historical alcohol intake in clinical application, The relationship between the decline in phosphatidylethanol concentration and the covariates time, demographic data and health data will be determined in statistical analysis.
Control group
Dose comparison

Outcomes
Primary outcome [1] 322972 0
phosphatidylethanol concentrations in erythrocytes
Timepoint [1] 322972 0
In habitual non-drinkers: one observation time only, a single blood collection.
For customary drinkers, blood collection and measurement of phosphatidylethanol at up to four time points (days 0, 7, 14 and 21),
For the voluntary abstainer arm, one blood collection and measurement before the period of abstinence, then weekly blood collection and measurements for 4 weeks during the period of abstinence.
Secondary outcome [1] 380403 0
Carbohydrate deficient transferrin in serum
Timepoint [1] 380403 0
In habitual non-drinkers: one observation time only, a single blood collection.
For customary drinkers, blood collection and measurement of phosphatidylethanol at up to four time points (days 0, 7, 14 and 21),
For the voluntary abstainer arm, one blood collection and measurement before the period of abstinence, then weekly blood collection and measurements for 4 weeks during the period of abstinence.

Eligibility
Key inclusion criteria
Men or non-pregnant women over 18 years will be recruited. A purpose of the research is to gain population-level information. Alcohol consumption is pervasive, so recruitment is not restricted, save for the exclusions mentioned below.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy,
Recent (last year) history of using other recreational drugs,
History of active alcohol-related illness,
Active psychiatric illness that might compromise data collection
Medical conditions that might affect handling of alcohol (specifically, advanced liver disease). Liver function impairment that is evidenced only by elevated serum concentrations of liver enzymes is not an exclusion.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Two arms (customary abstainers and customary alcohol drinkers) of the study do not involve any intervention, just a visit to check eligibility and visits to collect blood specimens.
Volunteers for the third arm of the study will be customary alcohol drinkers who voluntarily abstain for a month. Allocation to groups is therefore by choice and there is no concealment.
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
Other
Other design features
Assignment to treatment groups is by participant choice.
Non-drinkers choose to enter Substudy a of Study 1, which is the only choice for non-drinkers. Habitual drinkers can also choose to enter Substudy a of Study 1. For them, that is continue alcohol consumption as usual and two data/blood collections a week apart, Alternatively, drinkers can choose to enter Substudy b of Study 1 (continue alcohol consumption as usual, 3 weeks of data/blood collection) or Study 2 (stop drinking alcohol for a month, weekly data/blood collection),
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Descriptive
Calculation of pharmacokinetic parameters for elimination in voluntary abstainer group.
Non-linear mixed effects modelling to determine influence of alcohol consumption (diary), demographics and physical characteristics on concentrations of erythrocyte phosphatidylethanol and pharmacokinetics of elimination.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/02/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
80
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15945 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 29429 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 305044 0
Hospital
Name [1] 305044 0
Sir Charles Gairdner Hospital Research Advisory Committee
Country [1] 305044 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave,
Nedlands,
WA 6009
Country
Australia
Secondary sponsor category [1] 305407 0
Government body
Name [1] 305407 0
PathWest Laboratory Medicine
Address [1] 305407 0
Locked Bag 2009,
Nedlands WA 6909
Country [1] 305407 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305435 0
Sir Charles Gairdner & Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 305435 0
Ethics committee country [1] 305435 0
Australia
Date submitted for ethics approval [1] 305435 0
11/09/2019
Approval date [1] 305435 0
16/01/2020
Ethics approval number [1] 305435 0
RGS0000003522

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

Contacts
Principal investigator
Name 100374 0
Prof David A Joyce
Address 100374 0
Clinical Pharmacology & Toxicology,
PathWest Laboratory Medicine,
Locked Bag 2009,
Nedlands WA 6909
Country 100374 0
Australia
Phone 100374 0
+61 8 6457 2569
Fax 100374 0
Email 100374 0
[email protected]
Contact person for public queries
Name 100375 0
Jacob Ooi
Address 100375 0
Department of Hepatology,
Sir Charles Gairdner Hospital,
Hospital Ave,
Nedlands, WA 6009
Country 100375 0
Australia
Phone 100375 0
+61 412238129
Fax 100375 0
Email 100375 0
[email protected]
Contact person for scientific queries
Name 100376 0
Daniel White
Address 100376 0
Clinical Pharmacology & Toxicology,
PathWest Laboratory Medicine,
Locked Bag 2009,
Nedlands WA 6909
Country 100376 0
Australia
Phone 100376 0
+61 418 520 778
Fax 100376 0
Email 100376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in published papers (text, tables, figures and appendices) after complete de-identification.
When will data be available (start and end dates)?
From the time of result publication, for a period of at least 36 months.
Available to whom?
Researchers who can provide a methodologically sound proposal that has been approved by an independent review committee (Human Research Ethics Committee).
Available for what types of analyses?
To achieve aims in the approved proposal or for the purpose of individual patient meta-analysis.
How or where can data be obtained?
Proposals should be submitted to [email protected]. To gain access, requesting investigators will be required to sign a data access agreement and provide documentation of approval from an independent review committee.
After 36 months from publication, data will be available in the University of Western Australia data repository.


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.