Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study

March 4, 2020 updated by: Yale University
This is a pilot study to test the feasibility of conducting a text based smoking cessation trial with Emergency Department patients who are smokers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • have smoked >= 100 cigarettes lifetime
  • describe themselves as every or some day smokers
  • are able to give written informed consent
  • reside in Connecticut
  • own a cell phone with texting capability.

Exclusion Criteria:

  • inability to read or understand English
  • currently receiving formal tobacco dependence treatment
  • current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette)
  • currently using Zyban (bupropion), Wellbutrin (bupropion) or Chantix (varenicline) for smoking cessation
  • current suicide or homicide risk
  • current psychotic disorder
  • life-threatening or unstable medical or psychiatric condition
  • does not have phone with CT area code and with texting capability
  • lacks capacity to give informed consent
  • leaving the ED against medical advice
  • pregnant, nursing, or trying to conceive
  • incarcerated
  • resides in an extended care facility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Condition
Control or Standard Care condition. No intervention will be provided.
Experimental: Texting + NRT Condition
Enrollment in NCI's Smokefree TXT Program 4 weeks of Nicotine Replacement Patches 4 weeks of Nicotine Replacement Gum Faxed Referral CT Smokers Quitline
Other: Smokefree TXT Program
The SmokeFreeTxt program is a library consisting of ~130 brief messages that can be proactively sent to smokers' cellphones using software developed and maintained by NCI. The message content is informed by principles of cognitive behavioral therapy. They are sent to smokers at random times of day (during normal waking hours), up to 5 messages per day.
Drug: nicotine replacement patches
Subject will be given 4 weeks of Nicotine Replacement Patches, based on the amount he/she is smoking at baseline.
Drug: Nicotine Replacement Gum
Subjects will be given 10 pieces of 2mg Nicotine Replacement Gum x 28 days.
Behavioral: Faxed Referral CT Smokers Quitline
A faxed referral will be sent to the CT Smokers Quitline for the subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey of satisfaction and usage of Smokefree TXT Program
Time Frame: 1 month post enrollment
Study team will develop a survey to assess both subjects' satisfaction with the Smokefree TXT Program and ease of use.
1 month post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7 day point prevalence abstinence
Time Frame: 1 month post enrollment
7 day point prevalence abstinence will be assessed by asking if the subject has smoked even a puff in the past 7 days.
1 month post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Steven L Bernstein, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401013302
  • R01CA141479 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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