CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 57 enrolled
Drug / intervention
Nicotine patch +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04560868
NCT04560868Phase 1Completed
CompareCT.gov

Development of a mHealth Intervention for Ambivalent Smokers

Kaiser Permanente·interventional·Posted Sep 23, 2020·Updated Jan 23, 2023

In Brief

A Phase 1 clinical trial evaluating Control mHealth program, Experimental mHealth program, and 1 other intervention for Tobacco Use Disorder and 3 related conditions. Completed, enrolled 57 participants across 1 site.

Detailed Summary

The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Disorder, Smoking Cessation, Motivation, Behavior, Smoking
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedSep 23, 2020
Enrollment StartDec 16, 2020
Primary CompletionSep 27, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.8 years ago

Interventions

Control mHealth programdevice

The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.

Experimental mHealth programdevice

The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.

Nicotine patchdrug

Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.