ClinicalTrials.gg
RecruitingNCT07301151Updated Jun 24, 2026

PASCAL Feasibility Study

An interventional study of chatbot and no chatbot in Smoking Cessation and Smoking (Tobacco) Addiction, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by University of Minnesota · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The goal of this randomized study is to assess if a conversational agent (or chatbot) that the investigators have developed to help with quitting smoking is acceptable to people trying to quit smoking and to also collect initial information regarding its effectiveness.

In this study, some participants trying to quit smoking will be provided with this chatbot while other participants will not be

02

Conditions studied

  • Smoking Cessation
  • Smoking (Tobacco) Addiction

Keywords

  • cigarette smoking
  • chatbot
03

In context

Smoking Cessation

1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.

This study's planned enrollment of 120 is below the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Identify as Black or African American
  • Be at least 21 years of age
  • Meet a minimum smoking amount
  • Be willing to make a quit attempt in the next 30 days
  • Have a smartphone capable of downloading and running the study app
  • Be able to upload data from the app
  • Agree to receive text message reminders about study activities
  • Be a native English speaker
  • Reside in Minnesota.

Exclusion criteria

Exclusion Criteria:

  • Medicinal nicotine use would require careful monitoring by a healthcare professional
  • Medical condition or medication used likely to significantly interfere with study outcomes or to be significantly affected by changes in smoking behavior
  • Are pregnant or breastfeeding
05

Study design

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

Study arms

  • Experimental
    chatbot assisted smoking trigger management

    Other: chatbot

  • Active comparator
    control group

    Other: no chatbot

Interventions

  • Otherchatbot

    a chatbot will alert during predicted high risk smoking times and suggest approaches to manage potential smoking triggers

  • Otherno chatbot

    no chatbot is provided

06

What researchers measure

Primary outcomes

  1. Feasibility of trial procedures

    The proportion of enrolled participants who download the study app

    Time frame: 1 day

  2. Feasibility of study procedures

    The proportion of participants (among those who downloaded the app) who complete the week 2 post-quit visit

    Time frame: 2 weeks

  3. Health Information Technology Usability Evaluation Scale (Health-ITUES)

    This scale will be used to access the acceptability of study app. The scale consists of 20 questions scored from 1 to 5 with higher values indicating more positive response

    Time frame: 2 weeks

Secondary outcomes

  1. Average number of daily interactions with the study app

    Time frame: 2 weeks

  2. The average number of cigarettes smoked per day

    Time frame: 2 weeks

  3. Average number of nicotine lozenges used

    Time frame: 2 weeks

  4. The proportion of participants who complete the week 8 post-quit visit

    Time frame: 8 weeks

  5. The proportion of participants not smoking for the 7 day period before the week 2 visit

    Time frame: 2 weeks

  6. The proportion of participants not smoking for the 7 day period before the week 8 visits

    Time frame: 8 weeks

  7. The proportion of participants not smoking at all between the quit date and the week 2 visit

    Time frame: 2 weeks

  8. The proportion of participants not smoking at all between the quit date and the week 8 visit

    Time frame: 8 weeks

  9. Motivation to quit smoking

    Using a 1 - 10 scale on the contemplation to quit ladder (1 - no interest in quitting; 10 - will never smoke again)

    Time frame: 2 weeks

  10. Brief Questionnaire of Smoking Urges (QSU-Brief)

    Questionnaire assessing craving severity. Range for total score is 10 - 70 with higher score indicating greater craving

    Time frame: 2 weeks

  11. The Minnesota Nicotine Withdrawal Scale (MNWS)

    Questionnaire assessing withdrawal symptom severity. Range for total score is 0 - 36 with higher score indicating greater withdrawal symptoms

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Non-identifiable data will be deposited into the University of Minnesota Data Repository (DRUM)

No publications or documents are linked to this record.

09

Timeline

Tracking 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 Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.

Of 546 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 12 months is below that.

Counting every sponsor, half of 563 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
Dec 11, 2025
First posted
Dec 24, 2025
StartActual
Jun 11, 2026
Primary completionEst.
Jun 11, 2027
CompletionEst.
Jun 30, 2027
Last update
Jun 24, 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.
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07301151
Responsible party
Sponsor
First posted
Dec 24, 2025
Start date
Jun 11, 2026
Primary completion
Jun 11, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jun 24, 2026

Study contacts

Sheena Study Coordinator
Contact
gahmx008@umn.edu
612-626-5981
Michael Kotlyar
principal investigator · University of Minnesota

Oversight

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

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