Text Messaging for Smoking Cessation in College Health Clinics

March 30, 2020 updated by: Yale University

Text Messaging to Augment Physician Brief Advice for Smoking Cessation in College Health Clinics

This study is a randomized-controlled clinical trial which evaluates the efficacy of physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in promoting cigarette smoking in smokers enrolled in college.

The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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, 06515
        • Southern Connecticut State University

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 to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 through 24 years
  • Enrolled as a full/part time college student
  • A current smoker (Have smoked more than 100 cigarettes in their lifetime and now smoke every day or some days)
  • English-speaking
  • Interested in quitting
  • Have a cell phone for personal use with an unlimited text messaging plan.

Exclusion Criteria:

  • History of hypersensitivity/allergy to nicotine patch;
  • Serious arrhythmias - History of heart disease (myocardial infarction, severe chest pain, or coronary artery disease)
  • Current pregnancy/breastfeeding/plan for pregnancy

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Text messaging
Smoking counseling, nicotine patch, text messaging
Drug: Nicotine patch
Behavioral: Smoking counseling
Behavioral: Text messaging
Active Comparator: Standard of care
Smoking counseling, nicotine patch
Drug: Nicotine patch
Behavioral: Smoking counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Enrollment- Number of Participants Who Join the Study
Time Frame: baseline
We will report the number of persons who join the study.
baseline
Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.
Time Frame: 6- and 12- weeks
We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.
6- and 12- weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Abstinence
Time Frame: 6- and 12- weeks
biochemically confirmed point prevalence of self reported past 7-day abstinence
6- and 12- weeks

Collaborators and Investigators

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

Sponsor

Yale University

Collaborators

Southern Connecticut State University
University of New Haven

Investigators

  • Principal Investigator: Deepa R Camenga, MD, Yale School of Medicine

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

January 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404013813

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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