PASCAL Feasibility Study

NCT07301151 | Not Yet Recruiting

• 2 other identifiers: STUDY00026782P50MD017342
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Smoking (Tobacco) Addiction; Smoking Cessation

Keywords

cigarette smoking; chatbot

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

Study Arms (2)

chatbot assisted smoking trigger management

EXPERIMENTAL

Other: chatbot

control group

ACTIVE COMPARATOR

Other: no chatbot

Interventions

no chatbot OTHER

no chatbot is provided

control group

chatbot OTHER

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

chatbot assisted smoking trigger management

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking; Behavior, Addictive; Cigarette Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Michael Kotlyar

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheena Study Coordinator

CONTACT

612-626-5981; gahmx008@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)