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NCT Number: NCT07301151

PASCAL Feasibility Study

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

Recruiting

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Key information

Conditions

Smoking Cessation Behavior Behavior, Addictive Cigarette Smoking Compulsive Behavior Health Behavior Impulsive Behavior Smoking Smoking (Tobacco) Addiction Tobacco Smoking Tobacco Use

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

chatbot

Other

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

no chatbot

Other

no chatbot is provided

Primary outcomes

  1. Feasibility of trial procedures

    Time frame: 1 day

    The proportion of enrolled participants who download the study app

  2. Feasibility of study procedures

    Time frame: 2 weeks

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

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

    Time frame: 2 weeks

    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

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

    Time frame: 2 weeks

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

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

    Time frame: 2 weeks

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

  11. The Minnesota Nicotine Withdrawal Scale (MNWS)

    Time frame: 2 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sheena Study Coordinator

CONTACT

[email protected]

612-626-5981

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Feasibility of Using a Conversational Agent for Promoting Smoking Cessation Treatment Utilization

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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