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

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ClinicalTrials.gov Identifier: NCT02081144
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : January 22, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University

March 4, 2014
March 7, 2014
January 22, 2015
May 2014
October 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02081144 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study
Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study
This is a pilot study to test the feasibility of conducting a text based smoking cessation trial with Emergency Department patients who are smokers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Smoking
  • Tobacco Abstinence
  • 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.
  • 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
    Interventions:
    • Other: Smokefree TXT Program
    • Drug: nicotine replacement patches
    • Drug: Nicotine Replacement Gum
    • Behavioral: Faxed Referral CT Smokers Quitline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
50
October 2014
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02081144
0907005437-3
R01CA141479 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Yale University
Yale University
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
Principal Investigator: Steven L Bernstein, MD Yale University
Yale University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP