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CO Monitoring for Tobacco Cessation in Quitlines

NCT05327660 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2024-10-28

Study results available
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Summary

The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. The investigators hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.

Conditions

  • Tobacco Dependence

Interventions

COMBINATION_PRODUCT

Quitline Treatment as Usual (TAU)

Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).

COMBINATION_PRODUCT

Remote Carbon Monoxide (CO) Monitoring

Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.

COMBINATION_PRODUCT

Incentivized Remote CO Monitoring

Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.

Sponsors & Collaborators

  • Vincere Health

    collaborator INDUSTRY

  • Maryland State Tobacco Quitline

    collaborator OTHER

  • Consumer Wellness Solutions

    lead INDUSTRY

Principal Investigators

  • Kelly Carpenter, PhD · Consumer Wellness Solutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-11-01
Completion
2022-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327660 on ClinicalTrials.gov