Smoking CessationNCT07301151
PASCAL Feasibility Study
A study testing chatbot and no chatbot in people with Smoking Cessation and Smoking (Tobacco) Addiction, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking Cessation, Smoking (Tobacco) Addiction
- What is being tested?
- chatbot and no chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Agree to receive text message reminders about study activities
- Be a native English speaker
- Reside in Minnesota.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Feasibility of Using a Conversational Agent for Promoting Smoking Cessation Treatment Utilization
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
- Conditions
- Smoking Cessation, Smoking (Tobacco) Addiction
- Being tested
- chatbot, no chatbot
- Keywords
- cigarette smoking, chatbot
- Medical subject headings
- Smoking Cessation, Smoking, Behavior, Addictive, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chatbotOther
a chatbot will alert during predicted high risk smoking times and suggest approaches to manage potential smoking triggers
no chatbotOther
no chatbot is provided
| Study group | Role | What they receive |
|---|---|---|
| chatbot assisted smoking trigger management | Experimental | Not described Receives: Other: chatbot |
| control group | Active comparator | Not described Receives: Other: no chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of trial procedures
The proportion of enrolled participants who download the study app
Measured: 1 day
Feasibility of study procedures
The proportion of participants (among those who downloaded the app) who complete the week 2 post-quit visit
Measured: 2 weeks
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
Measured: 2 weeks
Secondary outcomes (11)
Average number of daily interactions with the study app
Measured: 2 weeks
The average number of cigarettes smoked per day
Measured: 2 weeks
Average number of nicotine lozenges used
Measured: 2 weeks
The proportion of participants who complete the week 8 post-quit visit
Measured: 8 weeks
The proportion of participants not smoking for the 7 day period before the week 2 visit
Measured: 2 weeks
The proportion of participants not smoking for the 7 day period before the week 8 visits
Measured: 8 weeks
The proportion of participants not smoking at all between the quit date and the week 2 visit
Measured: 2 weeks
The proportion of participants not smoking at all between the quit date and the week 8 visit
Measured: 8 weeks
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)
Measured: 2 weeks
Brief Questionnaire of Smoking Urges (QSU-Brief)
Questionnaire assessing craving severity. Range for total score is 10 - 70 with higher score indicating greater craving
Measured: 2 weeks
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start11 Jun 2026
- Primary completion11 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Michael Kotlyar, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301151
- Sponsor's protocol ID
- STUDY00026782
- Other IDs
- P50MD017342
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable data will be deposited into the University of Minnesota Data Repository (DRUM)