NCT06111755

Brief Summary

This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

October 26, 2023

Last Update Submit

August 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)

    7-day PPA at end of treatment with be confirmed via cotinine testing in saliva

    8 weeks

Secondary Outcomes (4)

  • Change in cigarettes smoked per day

    baseline, 4 weeks and 8 weeks

  • Percent days smoke-free

    up to 8 weeks

  • Average number of days to relapse

    2 weeks post quit date

  • Treatment satisfaction assessed using the Mobile Application Rating Scale User version

    up to 8 weeks

Study Arms (2)

SmokefreeTXT

ACTIVE COMPARATOR

Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT.

Other: SmokefreeTXT

SmokefreeTXT + smartband

EXPERIMENTAL

Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT + smartband.

Other: SmokefreeTXTDevice: Smartband

Interventions

National Cancer Institute's SmokefreeTXT is a text message quit smoking program available nationally. Users sign up and choose a target quit date that is within 2 weeks of their signup date. Users receive 3-5 text messages per day for up to 2 weeks pre-quit and 6 weeks post-quit. The quit date can be reset as often as needed by the user.

SmokefreeTXTSmokefreeTXT + smartband
SmartbandDEVICE

A smartband that will track smoking in real-time and ask the individual to confirm/deny smoking. Participants will be asked to wear the smartband during their waking hours and to charge it overnight.

SmokefreeTXT + smartband

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • daily smokers for at least 6 months
  • report an interest in quitting smoking.

You may not qualify if:

  • reporting being currently enrolled in another quit smoking program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National online recruitment

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Kathleen A Garrison, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

March 26, 2024

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations