CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 35 enrolled
Drug / intervention
Mailed nicotine replacement therapy +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/NCT04020718
NCT04020718Phase 4Completed

Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

Massachusetts General Hospital·interventional·Posted Jul 16, 2019·Updated Mar 10, 2022

In Brief

A Phase 4 clinical trial evaluating Brief telephone advice plus tailored text messages, Mailed nicotine replacement therapy, and 1 other intervention for Tobacco Use Cessation. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.

Study Details

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

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJul 16, 2019
Enrollment StartJan 31, 2020
Primary CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.0 years ago

Interventions

Brief telephone advice plus tailored text messagesbehavioral

All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit and quit date. Content is personalized with user's name and Massachusetts General Hospital resources.

Mailed nicotine replacement therapydrug

Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).

Proactive telephone coachingbehavioral

Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.