An observational study in Smoking, Cigarette Smoking and Electronic Cigarettes, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by University of Minnesota · Observational
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Among 371 studies in Cigarette Smoking with a site in United States — 68 open to participants now, 75 under way, 3 of them phase 3. Cigarette Smoking · United States.
Among the 371 studies in Cigarette Smoking with a site in United States, this one is the 8th largest by enrollment of the 30 observational ones that give a count, is one of 18 that started in 2017, is one of 30 observational ones, and was the 159th registered.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
Browse Cigarette Smoking studies →68 of the 371 studies in Cigarette Smoking with a site in United States are open now. Recruiting first, the newest first:
Roswell Park Cancer Institute · Sites in United States
Ages 18–30
Virginia Polytechnic Institute and State University · Sites in United States
Ages 21+
University of California, Irvine · Sites in United States
Ages 50–80
VA Office of Research and Development · Sites in United States
Ages 21+
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 21–50
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 61 Cigarette Smoking studies recruiting now, 38 (62%) set no upper age limit and 17 (28%) stop at 75 or younger; 1 takes children under 18; 32 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
371 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 35 · Phase 2 56 · Phase 3 10 · Phase 4 22
First in 1997; this study’s year is marked. 18 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 217 is above the median of 120 across 57 observational studies indexed under Cigarette Smoking.
Median enrollment 96 across the 340 interventional studies, 159 across the 30 observational. Of the 280 that completed or were terminated, 137 (49%) have results posted.
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20 of 371 have an industry lead sponsor. The 10 most frequent:
University of Minnesota is the lead sponsor of 1,217 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
University of Minnesota has 6 studies filed under Cigarette Smoking — fewer than ten, so there is no comparison to draw.
31 of the studies in Cigarette Smoking with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT05008848Phase 3Alliance for Clinical Trials in OncologyReaching Rural Cancer Survivors Who Smoke Using Text-Based Program | 2027-04-23 |
| NCT06945120Dana-Farber Cancer InstituteACT Lung Health Intervention: Phase Two | 2026-11-30 |
| NCT05836103Johns Hopkins Bloomberg School of Public HealthTesting the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation | 2026-11-30 |
| NCT05707871Wake Forest University Health SciencesCardiovascular Effects of Very Low Nicotine Content Cigarettes | 2026-12 |
Add all 31 to your calendar (.ics) → With an account.
Among the 371 studies in Cigarette Smoking with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will examine the level of toxicity of e-cigarette use compared to smokers and nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally, the study will look at the effect of varying voltage levels for e-cigarette users.
In this observational study, e-cigarette users, smokers, and non-users of e-cigarette or tobacco products (up to 134 per group) will be recruited from the Minneapolis-St. Paul area. This research will be conducted at the Tobacco Research Programs at the University of Minnesota. Subjects are screened for eligibility over the phone. If eligible after the phone screen, participants will be invited to attend orientation screening visit in the clinic where consent will be obtained and subjects will complete forms about their tobacco and e-cigarette use and medical history. Subjects who eligible will be asked to return for six visits over the course of six months.
At these appointments, subjects will provide biological specimen samples (buccal cells, urine and blood). Saliva will be collected before and after a smoking or vaping session. Non-users will only have 1 saliva collection.
Subjects will be asked for information pertaining to and e-cigarette and tobacco use and overall health.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's enrollment of 217 is above the median of 120 across 57 observational studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →University of Minnesota is the lead sponsor of 1,217 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
Compared within Cigarette Smoking, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Smoking. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Subjects will be recruited locally within reasonable distance from the University of Minnesota.
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.
Meet criteria for 1 of three groups:
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 authorized 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 authorized 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.
DNA Adducts
Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping
Time frame: 6 months
Urinary 8-iso-PGF-2α
Stability of Urinary 8-iso-PGF-2α (biomarkers of oxidative damage) over a 6-month sample period
Time frame: 6 months
Urinary PGEM
Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period
Time frame: 6 months
C-reactive protein
Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period
Time frame: 6 months
TNE
Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period
Time frame: 6 months
Ran from Jul 2017 to primary completion in Jun 2021, 46 months.
Of 24 observational studies under Cigarette Smoking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 46 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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