An interventional study of Flavored Ready-to-Drink alcoholic beverage use restriction in E-cigarette and Alcohol, sponsored by Medical University of South Carolina. Not yet recruiting. Open to participants aged 21 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Prevention
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).
402 studies on the registry are indexed under Vaping; 95 are open to participants now.
This study's planned enrollment of 30 is below the median of 79 across 322 interventional studies indexed under Vaping.
Browse Vaping studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the no-restriction control group will continue their usual alcohol and e-cigarette consumption.
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
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.
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
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
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Mar 2027, 5 months later.
Of 184 non-industry interventional studies with no phase under Vaping, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 5 months is below that.
Counting every sponsor, half of 208 studies reached it within 18 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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