ClinicalTrials.gg
RecruitingNCT06584929Updated Nov 13, 2026

Rural Smoking Cessation

An interventional study of Nicoderm CQ nicotine patch and Nicorette Nicotine Lozenges in Smoking Cessation, sponsored by Masonic Cancer Center, University of Minnesota. Recruiting at 2 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Masonic Cancer Center, University of Minnesota · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Updated Nov 13, 20261 site addedGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
544
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 920 studies in Smoking Cessation with a site in United States — 98 open to participants now, 126 under way, 7 of them phase 3. Smoking Cessation · United States.

Planned enrollment
191st of 872
544 · median 149
Started
2026
with 36 others
No phase
512 of 920
68 open now
Primary completion
2028-10
later than 107 of 125 live
Registered
850th of 920
by date

Among the 920 studies in Smoking Cessation with a site in United States, this one is the 191st largest by planned enrollment of the 872 interventional ones that give a count, is one of 37 that started in 2026, is one of 512 with no phase, reaches primary completion later than 107 of the 125 other live ones, and was the 850th registered.

Smoking Cessation

1,582 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.

Browse Smoking Cessation studies →

Open to participants now

98 of the 920 studies in Smoking Cessation with a site in United States are open now. Recruiting first, the newest first:

93 more — sign in →

All 98 open studies →

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 →

Who these studies take

Of the 137 Smoking Cessation studies recruiting now, 93 (68%) set no upper age limit and 37 (27%) stop at 75 or younger; 6 take children under 18; 41 take healthy volunteers.

This study: 21 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 920 studies in Smoking Cessation with a site in United States, or all of them as a file.
02

Study summary

Understanding ways to help people who live in rural areas quit smoking is a public health priority. quitting smoking among rural people who smoke is a critical public health concern. People in rural areas smoke at higher rates than those in urban areas, experience high rates of smoking caused cancers and deaths. We are recruiting rural people from around the country to better understand how different quit smoking methods can improve a person's chances of successfully quitting smoking.

Read the detailed description

This is a SMART, where eligible rural people who smoke (RPWS) can be randomized up to two times to different resources/ways to help quit smoking. For each randomization, participants will use the assigned resources for 3 months, and partake in surveys at baseline, 1, and 3 months, during which they will be asked several questions related to use of resources, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 3 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/) to determine biochemically confirmed abstinence.

03

Conditions studied

  • Smoking Cessation

Browse trials for

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • ≥ 21 years
  • smoke ≥ 5 cigarettes per day
  • daily access to their own iPhone/Android smartphone or tablet

Exclusion criteria

Exclusion Criteria:

  • past 30-day NRT use or listed on the NRT labels
  • currently pregnant/breastfeeding
Terms in these criteria, in plain language(1)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
544 participants (estimated)

Study arms

  • Experimental
    Intervention Condition

    Weekly text and email messages referring to Smokefree.gov, NRT Starter kit, free 2-week supply of patches (Nicoderm CQ in either 21 or 14 mg nicotine) and lozenges (Nicorette Nicotine Lozenges, Mint Flavor in either 4 or 2 mg nicotine) with NRT education plus referral to where to request more NRT.

    Drug: Nicoderm CQ nicotine patch · Drug: Nicorette Nicotine Lozenges

  • No intervention
    Control Condition

    Weekly text and email messages referring to Smokefree.gov

  • No intervention
    RHE - Intervention Condition

    Weekly text and email messages on reduced harm or exposure (RHE) tobacco products.

Interventions

  • DrugNicoderm CQ nicotine patch

    Two week supply provided to participants on study.

  • DrugNicorette Nicotine Lozenges

    Two week supply provided to participants on study.

06

What researchers measure

Primary outcomes

  1. Number of participants abstinent from all combustible tobacco products

    Biochemically-confirmed 7-day abstinence from all combustible tobacco products at 3 months.

    Time frame: 3 months

Secondary outcomes

  1. Cigarettes per day (CPD)

    Number of cigarettes smoked per day.

    Time frame: 1 and 3 months

07

Study locations

2 of 2 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Oct 2028, 30 months after the start.

Of 547 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 30 months is above that.

Counting every sponsor, half of 564 studies reached it within 24 months; a quarter within 12 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2024
First posted
Sep 5, 2024
StartActual
Mar 17, 2026
Primary completionEst.
Oct 1, 2028
CompletionEst.
Aug 31, 2029
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added
Show site
  • Duke University · Durham, United States
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    1 site added
    Show site
    • Duke University · Durham, United States
    + 2 other changes: verification date and design details

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 ↗

09

Registry details

Key details

Study ID
NCT06584929
Responsible party
Sponsor
First posted
Sep 5, 2024
Start date
Mar 17, 2026
Primary completion
Oct 1, 2028 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Nov 13, 2026

Study contacts

Dana Carroll, PhD
Contact
dcarroll@umn.edu
612-624-4511

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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