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NCT05327660

CO Monitoring for Tobacco Cessation in Quitlines

Completed Phase 1, PHASE2 Results posted Last updated 28 October 2024
What this trial tests

Phase 1, PHASE2 trial testing Quitline Treatment as Usual (TAU) in Tobacco Dependence in 229 participants. Completed in 1 November 2022.

Timeline
31 December 2021
Primary endpoint
1 November 2022
1 November 2022

Quick facts

Lead sponsorConsumer Wellness Solutions
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment229
Start date31 December 2021
Primary completion1 November 2022
Estimated completion1 November 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Consumer Wellness Solutions

Who can join

18 and older, any sex, with Tobacco Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Treatment Satisfaction Primary · 60 days

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.

GroupValue95% CI
Quitline Treatment as Usual (TAU)38
Quitline TAU Plus Remote CO Monitoring44
Quitline TAU Plus Incentivized Remote CO Monitoring56
Treatment Engagement Primary · 60 days

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

GroupValue95% CI
Quitline Treatment as Usual (TAU)2.2± 1.4
Quitline TAU Plus Remote CO Monitoring2.3± 1.6
Quitline TAU Plus Incentivized Remote CO Monitoring2.7± 1.9
Self-reported Tobacco Abstinence Primary · 60 days

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

GroupValue95% CI
Quitline Treatment as Usual (TAU)15
Quitline TAU Plus Remote CO Monitoring18
Quitline TAU Plus Incentivized Remote CO Monitoring25
Biochemically Verified Tobacco Abstinence Secondary · 60 days

CO monitor reading 60 days post randomization (must be 7ppm or less to be considered abstinent) collected via smartphone app

GroupValue95% CI
Quitline Treatment as Usual (TAU)6
Quitline TAU Plus Remote CO Monitoring14
Quitline TAU Plus Incentivized Remote CO Monitoring20
Engagement With CO Monitor Secondary · 60 days

Number of times remote CO monitor is used collected via smartphone app.

GroupValue95% CI
Quitline Treatment as Usual (TAU)7.7± 7.3
Quitline TAU Plus Remote CO Monitoring54.8± 49.6
Quitline TAU Plus Incentivized Remote CO Monitoring80.9± 48.5
Satisfaction With CO Monitor Secondary · 60 days

Satisfaction with CO monitor measures on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the CO monitor device and app 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.

GroupValue95% CI
Quitline Treatment as Usual (TAU)30
Quitline TAU Plus Remote CO Monitoring38
Quitline TAU Plus Incentivized Remote CO Monitoring51

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Tobacco Dependence

Currently open trials in the same condition.

Other Consumer Wellness Solutions trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05327660.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing