NCT02081144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 4, 2014

Last Update Submit

March 4, 2020

Conditions

SmokingTobacco Abstinence

Keywords

Standard Care ConditionTexting + NRT Condition

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month post enrollment

Secondary Outcomes (1)

  • 7 day point prevalence abstinence

    1 month post enrollment

Study Arms (2)

Control Condition

NO INTERVENTION

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

Texting + NRT Condition

EXPERIMENTAL

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 ProgramDrug: nicotine replacement patchesDrug: Nicotine Replacement GumBehavioral: Faxed Referral CT Smokers Quitline

Interventions

Smokefree TXT ProgramOTHER

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.

Texting + NRT Condition
nicotine replacement patchesDRUG

Subject will be given 4 weeks of Nicotine Replacement Patches, based on the amount he/she is smoking at baseline.

Texting + NRT Condition
Nicotine Replacement GumDRUG

Subjects will be given 10 pieces of 2mg Nicotine Replacement Gum x 28 days.

Texting + NRT Condition
Faxed Referral CT Smokers QuitlineBEHAVIORAL

A faxed referral will be sent to the CT Smokers Quitline for the subject.

Texting + NRT Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Steven L Bernstein, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 7, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 5, 2020

Record last verified: 2020-03

Locations

US(1)