Clinical trial · Interventional
Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes
Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes Through a Cancer Prevention and Biology Collaborative
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcohol Drinking | — | UNRESOLVED | — |
| Electronic Cigarette Use | — | UNRESOLVED | — |
| Substance Co-Use | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flavored Ready-to-Drink alcoholic beverage use restriction | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No-restriction Control Group
- description
- Participants assigned to the no-restriction control group will continue their usual alcohol and e-cigarette consumption.
- type
- EXPERIMENTAL
- label
- Restriction Group
- description
- 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.
- interventionNames
- Behavioral: Flavored Ready-to-Drink alcoholic beverage use restriction
Primary outcomes (1)
- measure
- Binary indicator of study completion
- timeFrame
- From enrollment to the end of treatment at 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 29 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available