NCT02367391

Brief Summary

This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 8, 2017

Completed
Last Updated

June 15, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

February 13, 2015

Results QC Date

January 18, 2017

Last Update Submit

May 24, 2017

Conditions

Nicotine Dependence, Cigarettes

Outcome Measures

Primary Outcomes (4)

  • Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)

    12 weeks

  • Sustained Abstinence at the 12-week Follow up

    12 weeks

  • Number of Days of Varenicline Use

    12 weeks

  • Number of Active Smoking Cessation Activities Used

    Number of activities completed out of 6

    12 weeks

Secondary Outcomes (3)

  • Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.

    12 weeks

  • Time (in Days) to Relapse After the Target Quit Day

    12 weeks

  • Total Score on the Positive Smoking Cessation Activities Measure

    12 weeks

Study Arms (2)

Motivational Text Messages

EXPERIMENTAL
Behavioral: Motivational Text Messages

Control

SHAM COMPARATOR
Behavioral: Control

Interventions

Motivational Text MessagesBEHAVIORAL

Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.

Motivational Text Messages
ControlBEHAVIORAL

Usual Care. All participants receive the active medication, Varenicline.

Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoke \>4 cigarettes/day for at least 6 months
  • Age 21+
  • Want to quit and ready to try in next 30 days
  • Willing to quit all forms of tobacco (including e-cigs)
  • Willing to use Chantix to try to quit
  • Have a cell phone able to receive text messages
  • Willing to attend 3 visits and use varenicline for smoking cessation
  • Plan to live in local area for next 6 months
  • Read and write in English
  • Women not pregnant and taking steps to avoid
  • Able to understand and willing to sign consent

You may not qualify if:

  • History of allergic reaction or other adverse event while using varenicline
  • Used a smoking cessation aid/medicine in past 1 month (including e-cigs)
  • Currently pregnant or nursing
  • Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts
  • Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months
  • Uses non-cigarette tobacco products and does not plan to quit all tobacco.
  • Has a history of kidney problems or receives dialysis
  • Had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks
  • Had a heart attack in the past 4 weeks
  • Mental conditions that would prohibit the participant from completing the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Yingst JM, Veldheer S, Hrabovsky S, Hammett E, Nicholson J, Berg A, Foulds J. Pilot Randomized Trial of an Automated Smoking Cessation Intervention via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care. J Health Commun. 2018;23(4):370-378. doi: 10.1080/10810730.2018.1453890. Epub 2018 Mar 26.

    PMID: 29578832DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Project Coordinator
Organization
Penn State College of Medicine
jyingst@phs.psu.edu
7175310003

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 20, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 15, 2017

Results First Posted

March 8, 2017

Record last verified: 2017-05

Locations

US(1)