PASCAL Feasibility Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking Cessation; Smoking (Tobacco) Addiction
• Intervention / Treatment: Other: chatbot; Other: no chatbot

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheena Study Coordinator; Phone Number: 612-626-5981; Email: gahmx008@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Other: no chatbot; no chatbot is provided
Experimental: chatbot assisted smoking trigger management	Other: chatbot; a chatbot will alert during predicted high risk smoking times and suggest approaches to manage potential smoking triggers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of trial procedures	The proportion of enrolled participants who download the study app	1 day
Feasibility of study procedures	The proportion of participants (among those who downloaded the app) who complete the week 2 post-quit visit	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	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of daily interactions with the study app		2 weeks
The average number of cigarettes smoked per day		2 weeks
Average number of nicotine lozenges used		2 weeks
The proportion of participants who complete the week 8 post-quit visit		8 weeks
The proportion of participants not smoking for the 7 day period before the week 2 visit		2 weeks
The proportion of participants not smoking for the 7 day period before the week 8 visits		8 weeks
The proportion of participants not smoking at all between the quit date and the week 2 visit		2 weeks
The proportion of participants not smoking at all between the quit date and the week 8 visit		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)	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	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	2 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Michael Kotlyar, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: chatbot; cigarette smoking
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior; Health Behavior; Tobacco Smoking; Tobacco Use; Behavior, Addictive; Smoking; Smoking Cessation; Cigarette Smoking
• Other Study ID Numbers: STUDY00026782; P50MD017342 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Non-identifiable data will be deposited into the University of Minnesota Data Repository (DRUM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No