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

Primary Purpose

Smoking, Tobacco Abstinence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Smokefree TXT Program
nicotine replacement patches
Nicotine Replacement Gum
Faxed Referral CT Smokers Quitline
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Standard Care Condition, Texting + NRT Condition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Condition

Texting + NRT Condition

Arm Description

Control or Standard Care condition. No intervention will be provided.

Enrollment in NCI's Smokefree TXT Program 4 weeks of Nicotine Replacement Patches 4 weeks of Nicotine Replacement Gum Faxed Referral CT Smokers Quitline

Outcomes

Primary Outcome Measures

Survey of satisfaction and usage of Smokefree TXT Program
Study team will develop a survey to assess both subjects' satisfaction with the Smokefree TXT Program and ease of use.

Secondary Outcome Measures

7 day point prevalence abstinence
7 day point prevalence abstinence will be assessed by asking if the subject has smoked even a puff in the past 7 days.

Full Information

First Posted
March 4, 2014
Last Updated
March 4, 2020
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02081144
Brief Title
Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study
Official Title
Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot study to test the feasibility of conducting a text based smoking cessation trial with Emergency Department patients who are smokers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tobacco Abstinence
Keywords
Standard Care Condition, Texting + NRT Condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Condition
Arm Type
No Intervention
Arm Description
Control or Standard Care condition. No intervention will be provided.
Arm Title
Texting + NRT Condition
Arm Type
Experimental
Arm Description
Enrollment in NCI's Smokefree TXT Program 4 weeks of Nicotine Replacement Patches 4 weeks of Nicotine Replacement Gum Faxed Referral CT Smokers Quitline
Intervention Type
Other
Intervention Name(s)
Smokefree TXT Program
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
nicotine replacement patches
Intervention Description
Subject will be given 4 weeks of Nicotine Replacement Patches, based on the amount he/she is smoking at baseline.
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Gum
Intervention Description
Subjects will be given 10 pieces of 2mg Nicotine Replacement Gum x 28 days.
Intervention Type
Behavioral
Intervention Name(s)
Faxed Referral CT Smokers Quitline
Intervention Description
A faxed referral will be sent to the CT Smokers Quitline for the subject.
Primary Outcome Measure Information:
Title
Survey of satisfaction and usage of Smokefree TXT Program
Description
Study team will develop a survey to assess both subjects' satisfaction with the Smokefree TXT Program and ease of use.
Time Frame
1 month post enrollment
Secondary Outcome Measure Information:
Title
7 day point prevalence abstinence
Description
7 day point prevalence abstinence will be assessed by asking if the subject has smoked even a puff in the past 7 days.
Time Frame
1 month post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L Bernstein, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

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

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