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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

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.

Condition or disease Intervention/treatment Phase
Smoking Tobacco Abstinence Other: Smokefree TXT Program Drug: nicotine replacement patches Drug: Nicotine Replacement Gum Behavioral: Faxed Referral CT Smokers Quitline Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study
Study Start Date : May 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081144


Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Steven L Bernstein, MD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02081144     History of Changes
Other Study ID Numbers: 0907005437-3
R01CA141479 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by Yale University:
Standard Care Condition
Texting + NRT Condition

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action