Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-29
SponsorMedical University of South Carolina
About this trial
This pilot randomized behavioral study evaluates the feasibility, adherence, and acceptability of an intervention to restrict flavored ready-to-drink (RTD) alcoholic beverages among young adults who regularly use both alcohol and e-cigarettes. Participants will complete a 2-week baseline period followed by a 2-week intervention period. Participants will be randomized to either avoid flavored RTD alcoholic beverages or continue their usual alcohol consumption.
Primary outcomes include feasibility, adherence, acceptability. Secondary outcomes include preliminary efficacy of flavored RTD restriction on alcohol consumption and e-cigarette use measured through daily electronic diaries; biomarkers of alcohol and nicotine exposure, including urinary ethyl glucuronide (EtG), urinary cotinine, and blood phosphatidylethanol (PEth).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
being between 21 and 29 years old,
currently moderate alcohol drinking (i.e., at least 4 standard drinks per week in the past 3 months), with flavored RTD beverages comprising at least 50% of total alcohol consumption,
current regular e-cigarette use (i.e., 20 out of 30 days every month in the past 3 months),
English-speaking,
Disqualifiers
Being in current cessation treatment for substances of interest in the study,
Having serious or unstable psychiatric or medical conditions,
Being pregnant or breastfeeding,
Use of other psychoactive substances unless prescribed and stable.
Trial design
Design model
Parallel
Treatments tested in this trial
Flavored Ready-to-Drink alcoholic beverage use restriction
BehavioralThe intervention under study is a behavioral restriction of flavored RTD alcoholic beverages among young adults who regularly use alcohol and e-cigarettes. Participants randomized to the intervention group will be instructed to avoid flavored RTD alcoholic beverages for two weeks while continuing all other alcohol and e-cigarette use ad libitum. Participants randomized to the control group will continue their usual alcohol and e- cigarette use without restrictions.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: No-restriction Control GroupNo intervention 0 interventions
Group B: Restriction GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Binary indicator of study completion
The primary endpoint is a binary indicator of completion of at least 75% of study visits and 75% of surveys.
Time frame
From enrollment to the end of treatment at 4 weeksSecondary outcomes
1
Number of standard drinks consumed
The total number of standard drinks consumed will be captured each day via Daily electronic diaries.
Time frame
From enrollment to the end of treatment at 4 weeks.2
Number of vaping sessions
The total number of vaping sessions will be captured each day via Daily electronic diaries.
Time frame
From enrollment to the end of treatment at 4 weeks.3
Blood phosphatidylethanol 16:0/18:1 (PEth)
Phosphatidylethanol 16:0/18:1 (PEth) will be measured in blood as an objective biomarker of recent alcohol exposure. PEth is formed in red blood cell membranes only in the presence of ethanol and can remain detectable for several weeks after alcohol consumption. Higher PEth concentrations generally reflect greater alcohol exposure over the preceding weeks, although values do not indicate the exact amount consumed or the timing of individual drinking episodes.
Time frame
Week -2, at enrollment.4
Urinary ethyl glucuronide (EtG)
Ethyl glucuronide (EtG) will be measured in urine specimens as an objective biomarker of recent alcohol exposure. EtG is a direct metabolite of ethanol that remains detectable in urine after alcohol itself has been eliminated, allowing assessment of alcohol exposure over the preceding several days. Higher urinary EtG concentrations generally indicate greater or more recent alcohol exposure, although EtG levels cannot be used to determine the exact amount of alcohol consumed or the degree of intoxication.
Time frame
Week -1, Week 0, Week 1, and Week 2 Study Visits.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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