CO Monitoring for Tobacco Cessation in Quitlines

NCT05327660 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2021-0056
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tobacco cessation; tobacco quitlines; carbon monoxide monitoring; incentives

Outcome Measures

Primary Outcomes (3)

• Treatment Satisfaction

  Rating of satisfaction with quitline services on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the quitline services provided where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.

  60 days

• Treatment Engagement

  Number of quitline calls each participant engages in, collected via clinical record system.

  60 days

• Self-reported Tobacco Abstinence

  7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey

  60 days

Secondary Outcomes (3)

• Biochemically Verified Tobacco Abstinence

  60 days

• Engagement With CO Monitor

  60 days

• Satisfaction With CO Monitor

  60 days

Study Arms (3)

Quitline treatment as usual (TAU)

ACTIVE COMPARATOR

Quitline services provided by participating state quitlines

Combination Product: Quitline Treatment as Usual (TAU)

Quitline TAU plus remote CO monitoring

EXPERIMENTAL

Quitline service plus daily CO monitoring via a smartphone app

Combination Product: Quitline Treatment as Usual (TAU); Combination Product: Remote Carbon Monoxide (CO) Monitoring

Quitline TAU plus incentivized remote CO monitoring

EXPERIMENTAL

Quitline TAU plus remote CO monitoring with small monetary incentives

Combination Product: Quitline Treatment as Usual (TAU); Combination Product: Incentivized Remote CO Monitoring

Interventions

Quitline Treatment as Usual (TAU) COMBINATION_PRODUCT

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

Quitline TAU plus incentivized remote CO monitoring; Quitline TAU plus remote CO monitoring; Quitline treatment as usual (TAU)

Remote Carbon Monoxide (CO) Monitoring COMBINATION_PRODUCT

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

Quitline TAU plus remote CO monitoring

Incentivized Remote CO Monitoring COMBINATION_PRODUCT

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.

Quitline TAU plus incentivized remote CO monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily cigarette smokers calling into participating quitlines
• year or older
• Reads and speaks English
• Has a smartphone with a data plan
• Willing to download and use study app
• Willing to use CO monitor

You may not qualify if:

• Pregnant or breast feeding

Sponsors & Collaborators

• Consumer Wellness Solutions: lead
• Vincere Health: collaborator
• Maryland State Tobacco Quitline: collaborator

Study Sites (1)

Optum Center for Wellbeing Research

Seattle, Washington, 98125, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Kristina Mullis
• Organization: Consumer Wellness Solutions/RVO Health

kmullis@rvohealth.com

765-265-9169

Study Officials

• Kelly Carpenter, PhD

  Consumer Wellness Solutions

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 14, 2022
• Study Start: December 31, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)