CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 153 enrolled
Drug / intervention
Mailed nicotine replacement therapy +2 moredrug
Likely dose
Mailed nicotine replacement therapy 2 mgfrom 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/NCT03174158
NCT03174158Phase 4Completed

A Text Messaging Intervention for Smoking Cessation Among Community Health Center Patients

Massachusetts General Hospital·interventional·Posted Jun 2, 2017·Updated Feb 7, 2020

In Brief

A Phase 4 clinical trial evaluating Mailed nicotine replacement therapy, Text messaging, and 1 other intervention for Smoking Cessation. Completed, enrolled 153 participants across 1 site.

Detailed Summary

This study is a four arm pilot randomized controlled trial testing the effect of a 12 week text messaging intervention and a mailed nicotine medication intervention, alone and in combination to a control condition consisting of brief behavioral advice and usual care. Research Aim 1: To test, in a 4 arm pilot randomized controlled trial (N=50/group), the effect of a text messaging program and mailed nicotine replacement therapy on smoking outcomes and medication use. Hypothesis 1: A text messaging intervention will increase the proportion of smokers making a quit attempt compared to smokers receiving no text messaging. Hypothesis 2: A text messaging intervention will increase adherence to nicotine replacement therapy compared to subjects receiving only 2 weeks of nicotine replacement therapy. Hypothesis 3: A text messaging intervention will increase the rate of biochemically confirmed past 7-day point prevalent tobacco abstinence at end of treatment compared to subjects receiving no text messaging intervention. Hypothesis 4: A text messaging intervention will increase the number of days not smoking compared to subjects receiving no text messaging intervention. Hypothesis 5: A text messaging intervention will decrease the number of cigarettes smoked per day compared to subjects receiving no text messaging intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 2, 2017
Enrollment StartNov 6, 2017
Primary CompletionJan 17, 2019
Study CompletionFeb 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.1 years ago

Interventions

Mailed nicotine replacement therapydrug

Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.

Text messagingbehavioral

12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.

Brief advicebehavioral

Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training