Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes

N/ANot Yet RecruitingNCT07840625

Medical University of South Carolina30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Alcohol Drinking Electronic Cigarette Use Substance Co-Use

Eligibility

Sex: ALLMin age: 21 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria 1. being between 21 and 29 years old, 2. 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, 3. current regular e-cigarette use (i.e., 20 out of 30 days every month in the past 3 months), 4. English-speaking, 5. access to a smartphone for diary reporting. Exclusion Criteria: 1. Being in current cessation treatment for substances of interest in the study, 2. Having serious or unstable psychiatric or medical conditions, 3. Being pregnant or breastfeeding, 4. Use of other psychoactive substances unless prescribed and stable. 5. Inability or unwillingness of the subject to give informed consent

Outcomes

Primary Outcomes

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 weeks

Secondary Outcomes

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.

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.

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.

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.

Urinary cotinine concentrations

Cotinine will be measured in urine as an objective biomarker of recent nicotine exposure. Cotinine is the primary metabolite of nicotine and remains detectable longer than nicotine itself, generally reflecting exposure over the preceding several days. Higher urinary cotinine concentrations generally indicate greater recent nicotine exposure, although levels cannot determine the exact amount consumed or distinguish among different sources of nicotine exposure.

Time frame: Week -1, Week 0, Week 1 and Week 2 Study Visits