E-cigaretteNCT07840625
Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes
A study testing Flavored Ready-to-Drink alcoholic beverage use restriction in people with E-cigarette and Alcohol, run by Medical University of South Carolina.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- E-cigarette, Alcohol
- What is being tested?
- Flavored Ready-to-Drink alcoholic beverage use restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes Through a Cancer Prevention and Biology Collaborative
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
- Being tested
- Flavored Ready-to-Drink alcoholic beverage use restriction
- Keywords
- Alcohol, Ready-to-Drink Alcohol, E-cigarette, Vaping, Alcohol Restriction
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavored Ready-to-Drink alcoholic beverage use restrictionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Flavored Ready-to-Drink alcoholic beverage use restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (5)
Number of standard drinks consumed
The total number of standard drinks consumed will be captured each day via Daily electronic diaries.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week -1, Week 0, Week 1 and Week 2 Study Visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-cigaretteStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Freitas Lemos, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840625
- Sponsor's protocol ID
- Pro00151811
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be shared with qualified investigators for future research related to alcohol use, nicotine or e-cigarette use, substance use patterns, biomarkers of exposure, cancer prevention, or related health outcomes. Data will be shared only after appropriate institutional and IRB approvals are obtained and in accordance with the informed consent provided by participants. Direct identifiers will not be included in shared datasets.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes Through a Cancer Prevention and Biology Collaborative
- ClinicalTrials.gov ID
- NCT07840625
- Acronym / sponsor ID
- Pro00151811
- Conditions
- E-cigarette, Alcohol
- Keywords
- Alcohol, Ready-to-Drink Alcohol, E-cigarette, Vaping, Alcohol Restriction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Flavored Ready-to-Drink alcoholic beverage use restrictionParticipants 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. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavored Ready-to-Drink alcoholic beverage use restrictionThe 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. | Behavioural | Restriction Group |
Primary outcome
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.
5 secondary outcomes
Number of standard drinks consumed
Time frame: From enrollment to the end of treatment at 4 weeks.
Number of vaping sessions
Time frame: From enrollment to the end of treatment at 4 weeks.
Blood phosphatidylethanol 16:0/18:1 (PEth)
Time frame: Week -2, at enrollment.
Urinary ethyl glucuronide (EtG)
Time frame: Week -1, Week 0, Week 1, and Week 2 Study Visits.
Urinary cotinine concentrations
Time frame: Week -1, Week 0, Week 1 and Week 2 Study Visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data may be shared with qualified investigators for future research related to alcohol use, nicotine or e-cigarette use, substance use patterns, biomarkers of exposure, cancer prevention, or related health outcomes. Data will be shared only after appropriate institutional and IRB approvals are obtained and in accordance with the informed consent provided by participants. Direct identifiers will not be included in shared datasets.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Flavored Ready-to-Drink alcoholic beverage use restriction in people with E-cigarette and Alcohol, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binary indicator of study completion (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.