An observational study in Tobacco Use, sponsored by University of Minnesota. Withdrawn at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-11-24.
Sponsored by University of Minnesota · Observational
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Among 311 studies in Tobacco Use with a site in United States — 52 open to participants now, 63 under way, 1 of them phase 3. Tobacco Use · United States.
Among the 311 studies in Tobacco Use with a site in United States, this one is the 22nd largest by enrollment of the 24 observational ones that give a count, is one of 21 that started in 2017, is one of 24 observational ones, and was the 93rd registered.
421 studies on the registry are indexed under Tobacco Use; 83 are open to participants now.
Browse Tobacco Use studies →52 of the 311 studies in Tobacco Use with a site in United States are open now. Recruiting first, the newest first:
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pennsylvania · Sites in United States
Ages 18+
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 18+ · Women only
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
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 50 Tobacco Use studies recruiting now, 28 (56%) set no upper age limit and 18 (36%) stop at 75 or younger; 2 take children under 18; 27 take healthy volunteers.
This study: 21 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
311 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 25 · Phase 2 22 · Phase 3 10 · Phase 4 9
First in 1992; this study’s year is marked. 21 started in 2017.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 120 across the 286 interventional studies, 174 across the 24 observational. Of the 232 that completed or were terminated, 82 (35%) have results posted.
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67 of 311 have an industry lead sponsor. The 10 most frequent:
University of Minnesota is the lead sponsor of 1,216 studies on the registry; 196 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 9 studies filed under Tobacco Use — fewer than ten, so there is no comparison to draw.
30 of the studies in Tobacco Use with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05707871Wake Forest University Health SciencesCardiovascular Effects of Very Low Nicotine Content Cigarettes | 2026-12 |
| NCT07710820RAI Services CompanyA Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers | 2026-12 |
| NCT05445804Johns Hopkins UniversityOral Cannabidiol for Tobacco Cessation | 2026-12-01 |
| NCT07598136RAI Services CompanyA Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers | 2026-12-17 |
| NCT04297592Mayo ClinicAntibiotic Prophylaxis in High-Risk Arthroplasty Patients | 2027-01 |
Add all 30 to your calendar (.ics) → With an account.
Among the 311 studies in Tobacco Use with a site in United States, from their registry updates:
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The purpose of the study is to collect human biological samples and measurements from people of various ethnic and racial backgrounds for projects related to the "Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking" Program Project Grant. These samples will be used to evaluate and compare biomarkers of tobacco exposure across Japanese Americans, Whites, and Native Hawaiians and to add to the Multiethnic Cohort (MEC) biorepository to develop or assess future biomarkers.
This cross-sectional, observational study will primarily recruit smokers from the MEC study. The biological samples from these smokers are being collected since they do not currently exist in the biorepository (e.g. buccal cells). Potential smokers from the three racial groups who meet specific inclusion criteria will be invited to participate in the study. Should recruitment from the MEC sample be insufficient, smokers who meet the criteria will be recruited from the general population. This study will involve one to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine.
Approximately 300 smokers will be recruited from the Multiethnic Cohort (MEC) study or the general population in Hawai'i. 100 participants from each of the three designated ethnic/racial groups: Native Hawaiians, Japanese Americans and Non-Hispanic Whites. All participants will be recruited from Hawai'i to reduce variation due to geographical location and maximize ability to recruit the targeted ethnic/racial groups.
This study will involve one to two home visits where demographics, tobacco use and exposure history, medical history and medication use, questionnaires assessing tobacco dependence, alcohol use, and environmental exposures will be administered. and biological samples will be collected including blood, buccal cells and urine.
Cigarette smokers who are Japanese American, Non-Hispanic Whites - two parents of non-Hispanic white descent or Native Hawaiians over the age of 18.
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:
One parent of Hawaiian descent.
Two parents of Japanese descent.
Two parents of non-Hispanic white descent.
Project 3: Analysis of 1,3-butadiene DNA adducts
Ethnic differences in butadiene-DNA adducts across racial groups to determine the relationship of DNA adducts to lung cancer and the influence of carcinogen metabolizing genes on DNA adduct formation, repair, and toxicity/mutagenicity.
Time frame: Baseline
Project 4: Correlation of DNA adducts of buccal cells and urinary markers and lung cancer risk
DNA adduct levels in oral cells, themselves or together with urinary biomarker levels, correlate with lung cancer risk across various ethnic/racial groups
Time frame: Baseline
Project 2: NNK α-hydroxylation
Analysis of biomarkers of NNK α-hydroxylation (bioactivation) pathway and the effect of P450 2A6 activity on this process.
Time frame: Baseline
Plan to share: Yes — Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used, and co-authorship is not required as a condition for receiving data. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
Supporting information: Study protocol
Time frame: Data will not be available until primary papers are accepted for publication.
Access criteria: Persons requesting data must do so in writing, identifying the affiliation and how the data will be used.
No publications or documents are linked to this record.
Start is estimated for Sep 2017; primary completion for Aug 2021, 47 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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