Trial Outcomes & Findings for Penn State TXT2Quit Study (NCT NCT02367391)
NCT ID: NCT02367391
Last Updated: 2017-06-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-06-15
Participant Flow
Participant milestones
| Measure |
Motivational Text Messages
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
|
Overall Study
COMPLETED
|
74
|
76
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Penn State TXT2Quit Study
Baseline characteristics by cohort
| Measure |
Motivational Text Messages
n=74 Participants
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=76 Participants
Control: Usual Care. All participants receive the active medication, Varenicline.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 12.3 • n=99 Participants
|
44.5 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
45.5 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=99 Participants
|
76 participants
n=107 Participants
|
150 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Motivational Text Messages
n=74 Participants
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=76 Participants
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)
|
23 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Motivational Text Messages
n=74 Participants
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=76 Participants
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Sustained Abstinence at the 12-week Follow up
|
6 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Motivational Text Messages
n=74 Participants
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=76 Participants
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Number of Days of Varenicline Use
|
55.4 days
Standard Deviation 37.2
|
55.7 days
Standard Deviation 35.5
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This data is presented for only participants who showed to Visit 2.
Number of activities completed out of 6
Outcome measures
| Measure |
Motivational Text Messages
n=60 Participants
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=62 Participants
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Number of Active Smoking Cessation Activities Used
|
4.5 activities
Standard Deviation 1.3
|
4.0 activities
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Motivational Text Messages
n=74 Participants
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=76 Participants
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Motivational Text Messages
n=74 Participants
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=76 Participants
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Time (in Days) to Relapse After the Target Quit Day
|
16.0 days
Standard Deviation 28.9
|
16.5 days
Standard Deviation 30.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This data is presented for only participants who showed to Visit 2.
Total score for 6 items (scored 0-3). Total score range 0-18.
Outcome measures
| Measure |
Motivational Text Messages
n=60 Participants
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=62 Participants
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Total Score on the Positive Smoking Cessation Activities Measure
|
10.5 activities
Standard Deviation 3.8
|
9.1 activities
Standard Deviation 4.2
|
Adverse Events
Motivational Text Messages
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Control
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Motivational Text Messages
n=74 participants at risk
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=76 participants at risk
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Endocrine disorders
Development of Diabetes
|
1.4%
1/74 • Number of events 1
|
0.00%
0/76
|
|
Hepatobiliary disorders
Gallbladder Surgery
|
0.00%
0/74
|
1.3%
1/76 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/74
|
1.3%
1/76 • Number of events 1
|
Other adverse events
| Measure |
Motivational Text Messages
n=74 participants at risk
Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
|
Control
n=76 participants at risk
Control: Usual Care. All participants receive the active medication, Varenicline.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.9%
11/74
|
14.5%
11/76
|
|
Psychiatric disorders
Vivid or Unusual Dreams
|
10.8%
8/74
|
11.8%
9/76
|
|
Psychiatric disorders
Nicotine Withdrawal Symptoms
|
13.5%
10/74
|
14.5%
11/76
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/74
|
1.3%
1/76
|
|
Psychiatric disorders
Thoughts of death
|
1.4%
1/74
|
1.3%
1/76
|
|
Endocrine disorders
Excessive Sweating
|
1.4%
1/74
|
1.3%
1/76
|
|
Eye disorders
Increased mucus production in eye
|
1.4%
1/74
|
0.00%
0/76
|
|
Nervous system disorders
Migraines
|
1.4%
1/74
|
0.00%
0/76
|
|
Gastrointestinal disorders
Increased Salivation
|
1.4%
1/74
|
0.00%
0/76
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/74
|
0.00%
0/76
|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain
|
0.00%
0/74
|
1.3%
1/76
|
|
Ear and labyrinth disorders
Ringing in ears
|
1.4%
1/74
|
0.00%
0/76
|
|
Gastrointestinal disorders
Vomitting
|
1.4%
1/74
|
0.00%
0/76
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/74
|
1.3%
1/76
|
|
Skin and subcutaneous tissue disorders
Skin Peeling
|
1.4%
1/74
|
0.00%
0/76
|
|
Reproductive system and breast disorders
Increase in hot flashes
|
1.4%
1/74
|
0.00%
0/76
|
|
Gastrointestinal disorders
Coughing up blood
|
0.00%
0/74
|
1.3%
1/76
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/74
|
1.3%
1/76
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/74
|
1.3%
1/76
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/74
|
1.3%
1/76
|
|
Ear and labyrinth disorders
Balance Problems
|
1.4%
1/74
|
0.00%
0/76
|
|
Social circumstances
Drug/Alcohol Rehab
|
1.4%
1/74
|
0.00%
0/76
|
|
Reproductive system and breast disorders
Hysterectomy
|
1.4%
1/74
|
0.00%
0/76
|
|
Reproductive system and breast disorders
Pregnancy
|
1.4%
1/74
|
0.00%
0/76
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place