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CompletedNCT02367391Updated Jun 15, 2017Results posted

Penn State TXT2Quit Study

An interventional study of Motivational Text Messages and Control in Nicotine Dependence, Cigarettes, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-15.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Nicotine Dependence, Cigarettes

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03

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 152 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
152 participants (actual)

Study arms

  • Experimental
    Motivational Text Messages

    Behavioral: Motivational Text Messages

  • Sham comparator
    Control

    Behavioral: Control

Interventions

  • BehavioralMotivational Text Messages

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

  • BehavioralControl

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

06

What researchers measure

Primary outcomes

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

    Time frame: 12 weeks

  2. Sustained Abstinence at the 12-week Follow up

    Time frame: 12 weeks

  3. Number of Days of Varenicline Use

    Time frame: 12 weeks

  4. Number of Active Smoking Cessation Activities Used

    Number of activities completed out of 6

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  3. Total Score on the Positive Smoking Cessation Activities Measure

    Total score for 6 items (scored 0-3). Total score range 0-18.

    Time frame: 12 weeks

07

Results

Posted Mar 8, 2017

Participant flow

Participant flow — Overall Study
MilestoneMotivational Text MessagesControl
Started7676
Completed7476
Not completed20

Outcome measures

PrimaryPoint Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)
Time frame:
12 weeks
Reported as:
Count of participants · Participants
Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)
ParticipantsMotivational Text MessagesControl
Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)2323
PrimarySustained Abstinence at the 12-week Follow up
Time frame:
12 weeks
Reported as:
Count of participants · Participants
Sustained Abstinence at the 12-week Follow up
ParticipantsMotivational Text MessagesControl
Sustained Abstinence at the 12-week Follow up69
PrimaryNumber of Days of Varenicline Use
Time frame:
12 weeks
Reported as:
Mean · days
Number of Days of Varenicline Use
daysMotivational Text MessagesControl
Number of Days of Varenicline Use55.4 ± 37.255.7 ± 35.5
PrimaryNumber of Active Smoking Cessation Activities Used

Number of activities completed out of 6

Time frame:
12 weeks
Reported as:
Mean · activities
Number of Active Smoking Cessation Activities Used
activitiesMotivational Text MessagesControl
Number of Active Smoking Cessation Activities Used4.5 ± 1.34.0 ± 1.5
SecondaryContinuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.
Time frame:
12 weeks
Reported as:
Count of participants · Participants
Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.
ParticipantsMotivational Text MessagesControl
Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.69
SecondaryTime (in Days) to Relapse After the Target Quit Day
Time frame:
12 weeks
Reported as:
Mean · days
Time (in Days) to Relapse After the Target Quit Day
daysMotivational Text MessagesControl
Time (in Days) to Relapse After the Target Quit Day16.0 ± 28.916.5 ± 30.6
SecondaryTotal Score on the Positive Smoking Cessation Activities Measure

Total score for 6 items (scored 0-3). Total score range 0-18.

Time frame:
12 weeks
Reported as:
Mean · activities
Total Score on the Positive Smoking Cessation Activities Measure
activitiesMotivational Text MessagesControl
Total Score on the Positive Smoking Cessation Activities Measure10.5 ± 3.89.1 ± 4.2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Motivational Text Messages—1/74 (1.4%)39/74 (52.7%)
Control—2/76 (2.6%)33/76 (43.4%)
Most frequent serious events
Most frequent serious events
EventMotivational Text MessagesControl
Development of DiabetesEndocrine disorders1/740/76
Gallbladder SurgeryHepatobiliary disorders0/741/76
Abdominal PainGastrointestinal disorders0/741/76
Most frequent other events
Showing 10 of 24
Most frequent other events
EventMotivational Text MessagesControl
NauseaGastrointestinal disorders11/7411/76
Nicotine Withdrawal SymptomsPsychiatric disorders10/7411/76
Vivid or Unusual DreamsPsychiatric disorders8/749/76
RashSkin and subcutaneous tissue disorders1/741/76
Thoughts of deathPsychiatric disorders1/741/76
Excessive SweatingEndocrine disorders1/741/76
Increased mucus production in eyeEye disorders1/740/76
MigrainesNervous system disorders1/740/76
Increased SalivationGastrointestinal disorders1/740/76
Atrial FibrillationCardiac disorders1/740/76

Baseline characteristics

Age, Continuous
Age, Continuous(years)Motivational Text MessagesControlTotal
Mean46.6 ± 12.344.5 ± 11.645.5 ± 11.9
Sex: Female, Male
Sex: Female, Male(Participants)Motivational Text MessagesControlTotal
Female455499
Male292251
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Motivational Text MessagesControlTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American5712
White6566131
More than one race000
Unknown or Not Reported336
Region of Enrollment
Region of Enrollment(participants)Motivational Text MessagesControlTotal
United States7476150
08

Study locations

1 site
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
09

References and documents

Publications

  • 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. PubMed 29578832 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02367391
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Jonathan Foulds (Professor, Milton S. Hershey Medical Center) — Principal investigator
First posted
Feb 20, 2015
Start date
Jan 2015
Primary completion
Oct 2015
Completion
Oct 2015
Results posted
Mar 8, 2017
Last update
Jun 15, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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