Trial Outcomes & Findings for A Text Messaging Program for Smokers in Primary Care (NCT NCT03174158)
NCT ID: NCT03174158
Last Updated: 2020-02-07
Results Overview
Self-reported quit attempt in the last 12 weeks defined as intentional not smoking for 24 hours or more ("During the past 12 weeks, have you quit smoking intentionally for 1 day or longer").
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
153 participants
Primary outcome timeframe
End of treatment (12 week post-enrollment)
Results posted on
2020-02-07
Participant Flow
Participant milestones
| Measure |
Brief Advice
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
|
Mailed Nicotine Replacement Therapy
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
|
Text Messaging + Mailed NRT
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
36
|
39
|
|
Overall Study
COMPLETED
|
35
|
37
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Text Messaging Program for Smokers in Primary Care
Baseline characteristics by cohort
| Measure |
Brief Advice
n=39 Participants
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=39 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
|
Mailed Nicotine Replacement Therapy
n=36 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
|
Text Messaging + Mailed NRT
n=39 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
53.0 years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
36 participants
n=5 Participants
|
39 participants
n=4 Participants
|
153 participants
n=21 Participants
|
|
Cigarettes per day
|
15.5 cigarettes per day
STANDARD_DEVIATION 7.1 • n=5 Participants
|
13.6 cigarettes per day
STANDARD_DEVIATION 7.7 • n=7 Participants
|
16.6 cigarettes per day
STANDARD_DEVIATION 6.8 • n=5 Participants
|
15.4 cigarettes per day
STANDARD_DEVIATION 6.5 • n=4 Participants
|
15.3 cigarettes per day
STANDARD_DEVIATION 7.1 • n=21 Participants
|
PRIMARY outcome
Timeframe: End of treatment (12 week post-enrollment)Self-reported quit attempt in the last 12 weeks defined as intentional not smoking for 24 hours or more ("During the past 12 weeks, have you quit smoking intentionally for 1 day or longer").
Outcome measures
| Measure |
Brief Advice
n=39 Participants
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=39 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Mailed Nicotine Replacement Therapy
n=36 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging + Mailed NRT
n=39 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
|---|---|---|---|---|
|
Quit Attempts
|
26 Participants
|
33 Participants
|
29 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-enrollmentSelf-reported abstinence "Have you smoked, even a puff, in the past 7 days?"
Outcome measures
| Measure |
Brief Advice
n=39 Participants
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=39 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Mailed Nicotine Replacement Therapy
n=36 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging + Mailed NRT
n=39 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
|---|---|---|---|---|
|
7 Day Point Prevalent Abstinence
|
4 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 weeks post-enrollment (end of treatment)Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?"
Outcome measures
| Measure |
Brief Advice
n=39 Participants
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=39 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Mailed Nicotine Replacement Therapy
n=36 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging + Mailed NRT
n=39 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
|---|---|---|---|---|
|
7 Day Point Prevalent Abstinence
|
4 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: week 2 post enrollmentSelf-reported milligrams of nicotine medication used
Outcome measures
| Measure |
Brief Advice
n=33 Participants
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=34 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Mailed Nicotine Replacement Therapy
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging + Mailed NRT
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
|---|---|---|---|---|
|
Milligrams of Nicotine Medication Used
|
84.2 milligrams during week 2
Standard Deviation 81.2
|
58.0 milligrams during week 2
Standard Deviation 91.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeks post-enrollment (end of treatment)Self-reported, "In the past 30 days, how many days did you have at least one cigarette?"
Outcome measures
| Measure |
Brief Advice
n=37 Participants
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=38 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Mailed Nicotine Replacement Therapy
n=35 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging + Mailed NRT
n=38 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
|---|---|---|---|---|
|
Percentage of Days Not Smoked
|
23.7 percentage of past 30 days
Standard Deviation 32.2
|
37.2 percentage of past 30 days
Standard Deviation 32.0
|
29.0 percentage of past 30 days
Standard Deviation 32.1
|
36.1 percentage of past 30 days
Standard Deviation 35.5
|
SECONDARY outcome
Timeframe: 12 weeks post-enrollment (end of treatment)Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million
Outcome measures
| Measure |
Brief Advice
n=1 Participants
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=3 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Mailed Nicotine Replacement Therapy
n=3 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging + Mailed NRT
n=2 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
|---|---|---|---|---|
|
Exhaled Carbon Monoxide
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Total reported over 2 weeks post-enrollmentSelf-reported number of days nicotine lozenge and/or patch used
Outcome measures
| Measure |
Brief Advice
n=29 Participants
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=33 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Mailed Nicotine Replacement Therapy
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging + Mailed NRT
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
|---|---|---|---|---|
|
Days Nicotine Medication Used
|
5.3 days out of 2 weeks
Standard Deviation 4.4
|
3.3 days out of 2 weeks
Standard Deviation 4.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Total reported over 1 week post-enrollmentSelf-reported number of milligrams nicotine medication used
Outcome measures
| Measure |
Brief Advice
n=30 Participants
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=36 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Mailed Nicotine Replacement Therapy
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging + Mailed NRT
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
|---|---|---|---|---|
|
Milligrams Nicotine Medication Used
|
33.8 milligrams during week 1
Standard Deviation 54.8
|
22.3 milligrams during week 1
Standard Deviation 45.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeks post enrollment (end of treatment)Self-reported number of cigarettes per day on days smoked, change
Outcome measures
| Measure |
Brief Advice
n=27 Participants
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=31 Participants
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Mailed Nicotine Replacement Therapy
n=29 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging + Mailed NRT
n=30 Participants
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
|---|---|---|---|---|
|
Change in Cigarettes Per Day
|
-9.3 change in cigarettes per day
Standard Deviation 8.3
|
-8.6 change in cigarettes per day
Standard Deviation 6.7
|
-11.3 change in cigarettes per day
Standard Deviation 7.3
|
-8.9 change in cigarettes per day
Standard Deviation 6.9
|
Adverse Events
Brief Advice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mailed Nicotine Replacement Therapy
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Text Messaging + Mailed NRT
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brief Advice
n=39 participants at risk
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
|
Text Messaging
n=39 participants at risk
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
|
Mailed Nicotine Replacement Therapy
n=36 participants at risk
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
|
Text Messaging + Mailed NRT
n=39 participants at risk
Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
5.6%
2/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
5.1%
2/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
|
Psychiatric disorders
Anxiety or agitation
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
5.6%
2/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
7.7%
3/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
|
General disorders
mouth soreness
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
5.6%
2/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
|
Psychiatric disorders
sleep disturbance
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
2.8%
1/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
2.6%
1/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
|
General disorders
lightheadedness
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
2.8%
1/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
2.8%
1/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
2.6%
1/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
2.8%
1/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
2.8%
1/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
|
Nervous system disorders
headache
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
2.8%
1/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
|
General disorders
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
5.6%
2/36 • 12 weeks
Adverse event data was collected at each outcome assessment
|
0.00%
0/39 • 12 weeks
Adverse event data was collected at each outcome assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place