Trial Outcomes & Findings for A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care for Homeless Smokers (NCT NCT02565381)
NCT ID: NCT02565381
Last Updated: 2017-07-14
Results Overview
The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide \<8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period
Results posted on
2017-07-14
Participant Flow
Some participants (N=8) enrolled in the study but did not return for randomization.
Participant milestones
| Measure |
Control (N=25)
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Financial Rewards (N=25)
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Text Messaging (N=25)
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Control (N=25)
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Financial Rewards (N=25)
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Text Messaging (N=25)
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
Baseline Characteristics
A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care for Homeless Smokers
Baseline characteristics by cohort
| Measure |
Control (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Text Messaging (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Fagerstrom Test for Nicotine Dependence
|
5.1 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Quitting confidence
|
6.8 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 2.4 • n=4 Participants
|
|
Quitting importance
|
8.8 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
8.5 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
8.9 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 1.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study periodPopulation: Participants with missing data at a given time point were assumed non-abstinent at that time point.
The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide \<8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks)
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 3
|
10 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 5
|
9 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 7
|
15 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 10
|
15 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 12
|
17 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 14
|
15 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 17
|
13 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 21
|
14 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 24
|
17 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 28
|
12 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 35
|
8 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 42
|
11 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 49
|
11 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Day 56
|
12 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants with missing data at a given time point were assumed non-abstinent at that time point.
Percentage of 14 assessment visits at which a participant is abstinent of smoking, defined as an exhaled carbon monoxide level \<8ppm.
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Percentage of Visits Abstinent of Smoking
|
51.1 percentage of visits
Standard Deviation 32.8
|
12.6 percentage of visits
Standard Deviation 22.1
|
11.7 percentage of visits
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: 8 weeksPoint-prevalence smoking abstinence, defined as an exhaled carbon monoxide level \<8ppm, at the 14th (final) study visit.
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Smoking Abstinence at End of Study
|
12 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Once per week for 8 weeksPopulation: Participants with missing data at a given time point are excluded from calculation of mean changes in cigarette consumption for that time point.
Changes in the average number of cigarettes per day relative to baseline, defined by self-report and repeatedly assessed at the 8 assessment visits occurring on Fridays.
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=24 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=24 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Change in Cigarette Consumption
Week 8
|
-7.9 Cigarettes per day
Standard Deviation 5.5
|
-8.7 Cigarettes per day
Standard Deviation 5.9
|
-5.4 Cigarettes per day
Standard Deviation 3.7
|
|
Change in Cigarette Consumption
Week 1
|
-8.5 Cigarettes per day
Standard Deviation 6.0
|
-5.3 Cigarettes per day
Standard Deviation 6.1
|
-6.0 Cigarettes per day
Standard Deviation 7.2
|
|
Change in Cigarette Consumption
Week 2
|
-8.6 Cigarettes per day
Standard Deviation 6.8
|
-6.7 Cigarettes per day
Standard Deviation 5.8
|
-7.5 Cigarettes per day
Standard Deviation 6.8
|
|
Change in Cigarette Consumption
Week 3
|
-12.3 Cigarettes per day
Standard Deviation 10.2
|
-8.5 Cigarettes per day
Standard Deviation 5.4
|
-7.7 Cigarettes per day
Standard Deviation 7.2
|
|
Change in Cigarette Consumption
Week 4
|
-11.1 Cigarettes per day
Standard Deviation 6.9
|
-8.0 Cigarettes per day
Standard Deviation 5.6
|
-9.5 Cigarettes per day
Standard Deviation 7.2
|
|
Change in Cigarette Consumption
Week 5
|
-10.2 Cigarettes per day
Standard Deviation 7.2
|
-9.4 Cigarettes per day
Standard Deviation 6.4
|
-7.9 Cigarettes per day
Standard Deviation 7.0
|
|
Change in Cigarette Consumption
Week 6
|
-10.4 Cigarettes per day
Standard Deviation 6.7
|
-6.2 Cigarettes per day
Standard Deviation 4.2
|
-5.4 Cigarettes per day
Standard Deviation 5.2
|
|
Change in Cigarette Consumption
Week 7
|
-10.1 Cigarettes per day
Standard Deviation 7.2
|
-8.6 Cigarettes per day
Standard Deviation 6.4
|
-8.1 Cigarettes per day
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 4 weeks and 8 weeksPopulation: Participants with missing data at a particular time point are excluded from calculation of mean change in ASI scores at that time point.
Past-month drug use severity (score range 0-1), past-month alcohol use severity (score range 0-1), and past-month psychiatric severity (0-1) were each assessed with the Addiction Severity Index (ASI) - 5th Edition, at baseline and at the 10th and 14th study visits. For each ASI measure, higher scores represent greater drug, alcohol, or psychiatric severity. Changes in ASI scores between baseline and 4 or 8 weeks can range from -1 to +1. When interpreting changes in scores, negative values indicate decreases in scores from baseline to 4 or 8 weeks, and positive values indicate increases in scores from baseline to 4 or 8 weeks.
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=24 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=24 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Change in Behavioral Health
ASI alcohol 8 wk change
|
0.01 units on a scale
Standard Deviation 0.13
|
-0.01 units on a scale
Standard Deviation 0.13
|
-0.04 units on a scale
Standard Deviation 0.14
|
|
Change in Behavioral Health
ASI alcohol 4 wk change
|
-0.04 units on a scale
Standard Deviation 0.10
|
-0.02 units on a scale
Standard Deviation 0.12
|
-0.09 units on a scale
Standard Deviation 0.13
|
|
Change in Behavioral Health
ASI drug 4 wk change
|
-0.04 units on a scale
Standard Deviation 0.07
|
-0.02 units on a scale
Standard Deviation 0.08
|
-0.03 units on a scale
Standard Deviation 0.09
|
|
Change in Behavioral Health
ASI drug 8 wk change
|
-0.01 units on a scale
Standard Deviation 0.08
|
-0.02 units on a scale
Standard Deviation 0.08
|
0 units on a scale
Standard Deviation 0.09
|
|
Change in Behavioral Health
ASI psychiatric 4 wk change
|
-0.04 units on a scale
Standard Deviation 0.13
|
-0.06 units on a scale
Standard Deviation 0.22
|
-0.01 units on a scale
Standard Deviation 0.20
|
|
Change in Behavioral Health
ASI psychiatric 8 wk change
|
0.08 units on a scale
Standard Deviation 0.17
|
-0.04 units on a scale
Standard Deviation 0.21
|
-0.04 units on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: 8 weeksPercentage of 14 assessment visits attended.
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Study Visit Attendance
|
71.1 percentage of visits
Standard Deviation 24.3
|
65.4 percentage of visits
Standard Deviation 32.2
|
65.7 percentage of visits
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: 8 weeksPercentage of 8 counseling visits attended.
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Counseling Visit Attendance
|
10.5 percentage of visits
Standard Deviation 12.8
|
17.0 percentage of visits
Standard Deviation 21.3
|
17.0 percentage of visits
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants with missing data at a given time point were excluded from calculation of mean past-week patch use at that time point.
Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays.
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=24 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=24 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Nicotine Patch Use
Week 1
|
4.1 Days
Standard Deviation 2.6
|
3.7 Days
Standard Deviation 2.7
|
4.5 Days
Standard Deviation 2.9
|
|
Nicotine Patch Use
Week 2
|
4.5 Days
Standard Deviation 2.6
|
4.9 Days
Standard Deviation 2.8
|
4.5 Days
Standard Deviation 2.9
|
|
Nicotine Patch Use
Week 3
|
4.9 Days
Standard Deviation 2.2
|
4.4 Days
Standard Deviation 2.9
|
4.9 Days
Standard Deviation 2.9
|
|
Nicotine Patch Use
Week 4
|
3.6 Days
Standard Deviation 2.8
|
4.3 Days
Standard Deviation 3.0
|
4.4 Days
Standard Deviation 2.8
|
|
Nicotine Patch Use
Week 5
|
4.6 Days
Standard Deviation 2.8
|
4.4 Days
Standard Deviation 2.7
|
4.9 Days
Standard Deviation 2.5
|
|
Nicotine Patch Use
Week 6
|
4.0 Days
Standard Deviation 3.0
|
3.5 Days
Standard Deviation 2.8
|
4.1 Days
Standard Deviation 2.7
|
|
Nicotine Patch Use
Week 7
|
4.6 Days
Standard Deviation 2.5
|
4.3 Days
Standard Deviation 2.8
|
3.8 Days
Standard Deviation 2.6
|
|
Nicotine Patch Use
Week 8
|
3.9 Days
Standard Deviation 2.9
|
3.6 Days
Standard Deviation 3.1
|
2.7 Days
Standard Deviation 2.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Until target number of participants is reached; anticipate ~6 monthsTotal time to recruit, enroll, and randomize 75 study participants.
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Recruitment Time
|
6 months
|
6 months
|
6 months
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksPercentage of participants who still have their mobile phone at the end of the study.
Outcome measures
| Measure |
Financial Rewards (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Mobile Phone Retention
|
15 Participants
|
13 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksText messaging group only: number who enrolled in SmokefreeTXT, number who replied to query texts sent by SmokefreeTXT.
Outcome measures
| Measure |
Financial Rewards (N=25)
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Control (N=25)
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Text Messaging (N=25)
n=25 Participants
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Use of Text Messaging Program
Enrolled in SmokefreeTXT
|
—
|
—
|
22 Participants
|
|
Use of Text Messaging Program
Replied to texts from SmokefreeTXT
|
—
|
—
|
7 Participants
|
Adverse Events
Control (N=25)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Financial Rewards (N=25)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Messaging (N=25)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control (N=25)
n=25 participants at risk
* Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
|
Financial Rewards (N=25)
n=25 participants at risk
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
|
Text Messaging (N=25)
n=25 participants at risk
* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
8.0%
2/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash at nicotine patch site
|
4.0%
1/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
8.0%
2/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
|
General disorders
Sweating
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
8.0%
2/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
|
General disorders
Headache
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
4.0%
1/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
0.00%
0/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
4.0%
1/25 • Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
|
Additional Information
Travis P. Baggett, MD, MPH (Principal Investigator)
Massachusetts General Hospital
Phone: 617-643-9314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place