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NCT Number: NCT07840625

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

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).

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Electronic Cigarette Use Smoking Substance Co-Use Vaping

Age range

21 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,
  • access to a smartphone for diary reporting.

Exclusion criteria

  • 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.
  • Inability or unwillingness of the subject to give informed consent

Treatment and study plan

Flavored Ready-to-Drink alcoholic beverage use restriction

Behavioral

The 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.

Primary outcomes

  1. Binary indicator of study completion

    Time frame: From enrollment to the end of treatment at 4 weeks

    The primary endpoint is a binary indicator of completion of at least 75% of study visits and 75% of surveys.

Secondary outcomes

  1. Number of standard drinks consumed

    Time frame: From enrollment to the end of treatment at 4 weeks.

    The total number of standard drinks consumed will be captured each day via Daily electronic diaries.

  2. Number of vaping sessions

    Time frame: From enrollment to the end of treatment at 4 weeks.

    The total number of vaping sessions will be captured each day via Daily electronic diaries.

  3. Blood phosphatidylethanol 16:0/18:1 (PEth)

    Time frame: Week -2, at enrollment.

    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.

  4. Urinary ethyl glucuronide (EtG)

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

    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.

  5. Urinary cotinine concentrations

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

    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.

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Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes Through a Cancer Prevention and Biology Collaborative

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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