PASCAL Feasibility Study

NCT ID: NCT07301151

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2027-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Smoking Cessation Smoking (Tobacco) Addiction

Keywords

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cigarette smoking chatbot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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chatbot assisted smoking trigger management

Group Type EXPERIMENTAL

chatbot

Intervention Type OTHER

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

control group

Group Type ACTIVE_COMPARATOR

no chatbot

Intervention Type OTHER

no chatbot is provided

Interventions

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chatbot

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

Intervention Type OTHER

no chatbot

no chatbot is provided

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Sheena Study Coordinator

Role: CONTACT

Phone: 612-626-5981

Email: [email protected]

Other Identifiers

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P50MD017342

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00026782

Identifier Type: -

Identifier Source: org_study_id