CClinicalTrials.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

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

Who can participate

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

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
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
    Recruiting
07

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.

08

Registry details

Key details

Study ID
NCT07301151
Lead sponsor
University of Minnesota
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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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