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

NCT07840625 | Not Yet Recruiting DMC

• 1 other identifier: Pro00151811
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

E-cigarette; Alcohol

Keywords

Alcohol; Ready-to-Drink Alcohol; E-cigarette; Vaping; Alcohol Restriction

Outcome Measures

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.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (5)

• Number of standard drinks consumed

  From enrollment to the end of treatment at 4 weeks.

• Number of vaping sessions

  From enrollment to the end of treatment at 4 weeks.

• Blood phosphatidylethanol 16:0/18:1 (PEth)

  Week -2, at enrollment.

• Urinary ethyl glucuronide (EtG)

  Week -1, Week 0, Week 1, and Week 2 Study Visits.

• Urinary cotinine concentrations

  Week -1, Week 0, Week 1 and Week 2 Study Visits

Study Arms (2)

No-restriction Control Group

NO INTERVENTION

Participants assigned to the no-restriction control group will continue their usual alcohol and e-cigarette consumption.

Restriction Group

EXPERIMENTAL

Participants assigned to the restriction group will be instructed to avoid flavored ready-to-drink alcoholic beverages for 2 weeks. They will not be asked to avoid unflavored alcoholic beverages or any e-cigarettes.

Behavioral: Flavored Ready-to-Drink alcoholic beverage use restriction

Interventions

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.

Restriction Group

Eligibility Criteria

• Age: 21 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share