None listed
Conditions
Brief summary
This is a collaborative, study that aims to determine the relationship between reported alcohol intake and concentration of phosphatidylethanol (PEth) in washed erythrocytes and documented patient covariates. It comprises two sub-studies. One involves healthy participants who will record their alcohol intake for up to three weeks and provide up to four blood specimens. Among these will be a subgroup of participants who customarily taken no alcohol. The other sub-study involves healthy participants who will abstain from alcohol for four weeks and provide four blood specimens. There is no drug intervention and no other requirement for lifestyle change. The purpose of the research is to translate an assay for PEth into a useful clinical tool in the identification and management of alcohol-related disease.
Interventions
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 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.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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.
Outcome results
None listed