Trial Outcomes & Findings for Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures (NCT NCT03502200)
NCT ID: NCT03502200
Last Updated: 2023-07-21
Results Overview
Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
350 participants
Primary outcome timeframe
Daily for 12 weeks
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
E-cigarette
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
175
|
|
Overall Study
COMPLETED
|
132
|
127
|
|
Overall Study
NOT COMPLETED
|
43
|
48
|
Reasons for withdrawal
| Measure |
E-cigarette
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
36
|
38
|
|
Overall Study
Study Team Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
Age was not collected for 4 participants
Baseline characteristics by cohort
| Measure |
E-cigarette
n=175 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=175 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.26 years
STANDARD_DEVIATION 12.66 • n=173 Participants • Age was not collected for 4 participants
|
54.19 years
STANDARD_DEVIATION 12.47 • n=173 Participants • Age was not collected for 4 participants
|
54.72 years
STANDARD_DEVIATION 12.56 • n=346 Participants • Age was not collected for 4 participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=173 Participants • Sex was not collected for 4 participants
|
105 Participants
n=173 Participants • Sex was not collected for 4 participants
|
212 Participants
n=346 Participants • Sex was not collected for 4 participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=173 Participants • Sex was not collected for 4 participants
|
68 Participants
n=173 Participants • Sex was not collected for 4 participants
|
134 Participants
n=346 Participants • Sex was not collected for 4 participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=175 Participants
|
2 Participants
n=175 Participants
|
4 Participants
n=350 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
170 Participants
n=175 Participants
|
171 Participants
n=175 Participants
|
341 Participants
n=350 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=175 Participants
|
2 Participants
n=175 Participants
|
5 Participants
n=350 Participants
|
|
Cigarettes Smoked per Day
|
16.78 cigarettes per day
STANDARD_DEVIATION 8.16 • n=172 Participants • 5 Participants were missing data on cigarettes per day smoked at baseline
|
17.41 cigarettes per day
STANDARD_DEVIATION 8.21 • n=173 Participants • 5 Participants were missing data on cigarettes per day smoked at baseline
|
17.10 cigarettes per day
STANDARD_DEVIATION 8.18 • n=345 Participants • 5 Participants were missing data on cigarettes per day smoked at baseline
|
PRIMARY outcome
Timeframe: Daily for 12 weeksSelf-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.
Outcome measures
| Measure |
E-cigarette
n=175 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=175 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes
|
41 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: 12 weeksIntent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an iCO reading less than or equal to 8. A portable exhaled carbon monoxide detector confirms daily smoking status. Used to evaluate changes iCO, a biomarker of tobacco constituent exposure and other health effects.
Outcome measures
| Measure |
E-cigarette
n=175 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=175 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence
|
22 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the baseline survey; age was not collected for 4 participants
Assess participant age from the sociodemographic questionnaire
Outcome measures
| Measure |
E-cigarette
n=173 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=173 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Sociodemographic Questionnaire - Age
|
55.26 years
Standard Deviation 12.66
|
54.19 years
Standard Deviation 12.47
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the baseline survey; sex was not collected for 4 participants
Assess participant sex from the sociodemographic questionnaire
Outcome measures
| Measure |
E-cigarette
n=173 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=173 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Sociodemographic Questionnaire - Sex
Male
|
66 Participants
|
68 Participants
|
|
Sociodemographic Questionnaire - Sex
Female
|
107 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the baseline survey; marital status was not collected for 4 participants
Assess participant marital status from the sociodemographic questionnaire
Outcome measures
| Measure |
E-cigarette
n=173 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=173 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Sociodemographic Questionnaire - Marital Status
Married
|
55 Participants
|
56 Participants
|
|
Sociodemographic Questionnaire - Marital Status
Divorced/Separated
|
50 Participants
|
46 Participants
|
|
Sociodemographic Questionnaire - Marital Status
Widowed
|
23 Participants
|
23 Participants
|
|
Sociodemographic Questionnaire - Marital Status
Not married, but living with romantic partner
|
16 Participants
|
18 Participants
|
|
Sociodemographic Questionnaire - Marital Status
Romantic partner (not living with)
|
5 Participants
|
5 Participants
|
|
Sociodemographic Questionnaire - Marital Status
Never married and not in current romantic relationship
|
24 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: BaselineAssess participant ethnicity from the sociodemographic questionnaire
Outcome measures
| Measure |
E-cigarette
n=175 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=175 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Sociodemographic Questionnaire - Ethnicity
Hispanic or Latino
|
2 Participants
|
2 Participants
|
|
Sociodemographic Questionnaire - Ethnicity
Not Hispanic or Latino
|
170 Participants
|
171 Participants
|
|
Sociodemographic Questionnaire - Ethnicity
Unknown or Not Reported
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the baseline survey; employment data was not collected for 4 participants; 2 additional participants refused to answer the employment items
Assess participant employment status from the sociodemographic questionnaire
Outcome measures
| Measure |
E-cigarette
n=172 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=172 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Sociodemographic Questionnaire - Employment Status
Employed by others part-time for wages
|
8 Participants
|
12 Participants
|
|
Sociodemographic Questionnaire - Employment Status
Employed by other full-time for wages
|
26 Participants
|
32 Participants
|
|
Sociodemographic Questionnaire - Employment Status
Self-employed
|
11 Participants
|
13 Participants
|
|
Sociodemographic Questionnaire - Employment Status
Out of work
|
17 Participants
|
21 Participants
|
|
Sociodemographic Questionnaire - Employment Status
Homemaker
|
11 Participants
|
3 Participants
|
|
Sociodemographic Questionnaire - Employment Status
Retired
|
30 Participants
|
31 Participants
|
|
Sociodemographic Questionnaire - Employment Status
Unable to work/Disabled
|
69 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the baseline survey; household income was not collected for 4 participants; 7 additional participants refused to answer the income item
Assess participant socioeconomic status via yearly household income
Outcome measures
| Measure |
E-cigarette
n=170 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=169 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Sociodemographic Questionnaire - Socioeconomic Status
<$35,000
|
136 Participants
|
136 Participants
|
|
Sociodemographic Questionnaire - Socioeconomic Status
≥$35,000
|
34 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who completed their 12 week visit and provided responses to each item on the cigarette/e-cigarette dependency scale questionnaire. Participants in the treatment as usual arm were not assessed with the e-cigarette dependence scale as it is only applicable to the e-cigarette arm.
Assess e-cigarette and cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.
Outcome measures
| Measure |
E-cigarette
n=121 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=124 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Cigarette/EC Dependency Scale
e-Cigarette Dependence Scale
|
12.63 units on a scale
Standard Deviation 4.99
|
—
|
|
Cigarette/EC Dependency Scale
Cigarette Dependence Scale
|
14.42 units on a scale
Standard Deviation 4.51
|
14.11 units on a scale
Standard Deviation 4.60
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who responded to the drug effects liking questionnaire within 1 week of their week 12 visit. Participants in the treatment as usual arm were not assessed with the e-cigarette drug effects and liking questionnaires as they are only applicable to the e-cigarette arm.
Assess the desire and liking of products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness Scores range from 1 to 5 with higher scores indicating greater strength (effect from smoking cigarettes/vaping e-cigarettes) or liking (liking of effect from smoking cigarettes/vaping e-cigarettes)
Outcome measures
| Measure |
E-cigarette
n=74 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=66 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Drug Effects/Liking Questionnaire
Effect from smoking cigarettes
|
2.81 score on a scale
Standard Deviation 1.32
|
3.20 score on a scale
Standard Deviation 1.30
|
|
Drug Effects/Liking Questionnaire
Liking of effect after smoking cigarettes
|
3.16 score on a scale
Standard Deviation 1.17
|
2.97 score on a scale
Standard Deviation 1.23
|
|
Drug Effects/Liking Questionnaire
Effect from vaping e-cigarette
|
2.80 score on a scale
Standard Deviation 1.10
|
—
|
|
Drug Effects/Liking Questionnaire
Liking of effect from vaping e-cigarette
|
3.39 score on a scale
Standard Deviation 1.07
|
—
|
SECONDARY outcome
Timeframe: Week 1 (Baseline)Population: Participants who completed the cigarette purchase task at baseline.
Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their own brand cigarette. Specifically they will be asked, "How much would you be willing to pay for a puff of your usual cigarette brand?".
Outcome measures
| Measure |
E-cigarette
n=170 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=167 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Cigarette Purchase Task - Breakpoint
|
2.62 Dollars
Standard Deviation 11.16
|
5.96 Dollars
Standard Deviation 27.42
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Participants who completed their 12 week visit. Participants in the treatment as usual arm were not assessed with the e-cigarette QSU questionnaire as it is only applicable to the e-cigarette arm. Participants in the e-cigarette arm were not assessed with the NRT QSU questionnaire as it is only applicable to the treatment as usual arm.
Smoking and vaping urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette") for EC users. This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.
Outcome measures
| Measure |
E-cigarette
n=128 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=125 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
QSU Desire (cigarette)
|
12.97 score on a scale
Standard Deviation 9.72
|
13.66 score on a scale
Standard Deviation 10.38
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
QSU Relief (cigarette)
|
10.13 score on a scale
Standard Deviation 7.98
|
10.22 score on a scale
Standard Deviation 7.37
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
QSU Desire (e-cigarette)
|
16.76 score on a scale
Standard Deviation 10.71
|
—
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
QSU Relief (e-cigarette)
|
11.82 score on a scale
Standard Deviation 8.26
|
—
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
QSU Desire (NRT)
|
—
|
10.56 score on a scale
Standard Deviation 8.41
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
QSU Relief (NRT)
|
—
|
8.69 score on a scale
Standard Deviation 6.84
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Participants who completed their 12 week visit
Asses Nicotine withdrawal and smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal (MNWS) or more craving to smoke (MNWS Craving).
Outcome measures
| Measure |
E-cigarette
n=128 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=126 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Minnesota Nicotine Withdrawal Scale
MNWS
|
1.24 score on a scale
Standard Deviation 1.01
|
1.38 score on a scale
Standard Deviation 1.07
|
|
Minnesota Nicotine Withdrawal Scale
MNWS Craving
|
1.98 score on a scale
Standard Deviation 1.54
|
2.22 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Participants who continued to smoke cigarettes at their week 12 visit and provided responses to both the baseline and 12 week motivation ruler questionnaire.
Assess for changes in motivation from baseline to week 12 among participants who continue to smoke. Rulers including importance, confidence, and readiness to quit smoking (3-items total, with a scale ranging from 0 "not at all important/confident/ready" to 10 "extremely important/confident/ready"). Medians reported are change from baseline \[week 12 score - baseline score\] where negative values indicate a decrease in motivation over time and positive values indicate an increase in motivation over time.
Outcome measures
| Measure |
E-cigarette
n=83 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=88 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Change in Motivation Rulers (Scale) From Baseline to Week 12
Importance
|
0 score on a scale
Interval -1.0 to 1.0
|
0 score on a scale
Interval -2.0 to 0.0
|
|
Change in Motivation Rulers (Scale) From Baseline to Week 12
Readiness
|
-0.5 score on a scale
Interval -2.0 to 0.0
|
0 score on a scale
Interval -3.0 to 0.0
|
|
Change in Motivation Rulers (Scale) From Baseline to Week 12
Confidence
|
0 score on a scale
Interval -2.0 to 2.0
|
0 score on a scale
Interval -2.5 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 (baseline)Population: Participants who completed the tobacco use history questionnaire at baseline
Assess years of smoking from the tobacco use history questionnaire
Outcome measures
| Measure |
E-cigarette
n=171 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=172 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Tobacco Use History Questionnaire - Years of Smoking
|
34.15 years
Standard Deviation 12.99
|
31.59 years
Standard Deviation 14.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 (baseline)Population: Participants who completed the tobacco use history questionnaire at baseline
Assess average number of cigarettes per day with the tobacco use history questionnaire
Outcome measures
| Measure |
E-cigarette
n=172 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=173 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Tobacco Use History Questionnaire - Cigarettes Per Day
|
16.78 cigarettes per day
Standard Deviation 8.16
|
17.41 cigarettes per day
Standard Deviation 8.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 (baseline)Population: Participants who completed the tobacco use history questionnaire at baseline
Assess number of previous 24-hour quit attempts with the tobacco use history questionnaire
Outcome measures
| Measure |
E-cigarette
n=167 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=170 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Tobacco Use History Questionnaire - 24-hour Quit Attempts
|
0.93 quit attempts
Standard Deviation 2.39
|
0.82 quit attempts
Standard Deviation 1.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 (baseline)Population: Participants who completed the tobacco use history questionnaire at baseline
Assess number of smokers in the household with the tobacco use history questionnaire
Outcome measures
| Measure |
E-cigarette
n=173 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=173 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Tobacco Use History Questionnaire - Number of Smokers in the Household
|
1.59 people
Standard Deviation 0.84
|
1.53 people
Standard Deviation 0.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 (baseline)Population: Participants who completed the baseline survey
Assess cigarette expectance effects with the tobacco use history questionnaire
Outcome measures
| Measure |
E-cigarette
n=173 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=173 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm angry, a cigarette can help calm me down. · Disagree
|
12 Participants
|
19 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm angry, a cigarette can help calm me down. · Disagree a little
|
9 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm angry, a cigarette can help calm me down. · Agree a little
|
23 Participants
|
24 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm angry, a cigarette can help calm me down. · Agree
|
129 Participants
|
129 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm angry, a cigarette can help calm me down. · Refuse to answer / Don't know
|
0 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes are good for dealing with boredom · Disagree
|
26 Participants
|
27 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes are good for dealing with boredom · Disagree a little
|
23 Participants
|
12 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes are good for dealing with boredom · Agree a little
|
28 Participants
|
33 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes are good for dealing with boredom · Agree
|
95 Participants
|
101 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes are good for dealing with boredom · Refuse to answer / Don't know
|
1 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking keeps my weight down · Disagree
|
103 Participants
|
100 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking keeps my weight down · Disagree a little
|
12 Participants
|
10 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking keeps my weight down · Agree a little
|
22 Participants
|
23 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking keeps my weight down · Agree
|
33 Participants
|
37 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking keeps my weight down · Refuse to answer / Don't know
|
3 Participants
|
3 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm upset with someone, a cigarette helps me cope · Disagree
|
18 Participants
|
16 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm upset with someone, a cigarette helps me cope · Disagree a little
|
5 Participants
|
8 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm upset with someone, a cigarette helps me cope · Agree a little
|
26 Participants
|
17 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm upset with someone, a cigarette helps me cope · Agree
|
124 Participants
|
132 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm upset with someone, a cigarette helps me cope · Refuse to answer / Don't know
|
0 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
If I have nothing to do, a smoke can help kill time · Disagree
|
25 Participants
|
28 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
If I have nothing to do, a smoke can help kill time · Disagree a little
|
14 Participants
|
10 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
If I have nothing to do, a smoke can help kill time · Agree a little
|
28 Participants
|
28 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
If I have nothing to do, a smoke can help kill time · Agree
|
106 Participants
|
107 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
If I have nothing to do, a smoke can help kill time · Refuse to answer / Don't know
|
0 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm feeling down, a cigarette can really make me feel good · Disagree
|
49 Participants
|
48 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm feeling down, a cigarette can really make me feel good · Disagree a little
|
18 Participants
|
23 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm feeling down, a cigarette can really make me feel good · Agree a little
|
45 Participants
|
36 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm feeling down, a cigarette can really make me feel good · Agree
|
61 Participants
|
66 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm feeling down, a cigarette can really make me feel good · Refuse to answer / Don't know
|
0 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes keep me from eating more than I should · Disagree
|
92 Participants
|
85 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes keep me from eating more than I should · Disagree a little
|
15 Participants
|
15 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes keep me from eating more than I should · Agree a little
|
28 Participants
|
23 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes keep me from eating more than I should · Agree
|
36 Participants
|
47 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Cigarettes keep me from eating more than I should · Refuse to answer / Don't know
|
2 Participants
|
3 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm alone, a cigarette can help me pass the time · Disagree
|
31 Participants
|
42 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm alone, a cigarette can help me pass the time · Disagree a little
|
15 Participants
|
12 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm alone, a cigarette can help me pass the time · Agree a little
|
30 Participants
|
23 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm alone, a cigarette can help me pass the time · Agree
|
96 Participants
|
95 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
When I'm alone, a cigarette can help me pass the time · Refuse to answer / Don't know
|
1 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking cigarettes calms me down when I feel nervous · Disagree
|
13 Participants
|
15 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking cigarettes calms me down when I feel nervous · Disagree a little
|
3 Participants
|
10 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking cigarettes calms me down when I feel nervous · Agree a little
|
32 Participants
|
21 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking cigarettes calms me down when I feel nervous · Agree
|
125 Participants
|
126 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking cigarettes calms me down when I feel nervous · Refuse to answer / Don't know
|
0 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking helps me control my weight · Disagree
|
110 Participants
|
109 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking helps me control my weight · Disagree a little
|
17 Participants
|
15 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking helps me control my weight · Agree a little
|
16 Participants
|
17 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking helps me control my weight · Agree
|
26 Participants
|
29 Participants
|
|
Tobacco Use History Questionnaire - Cigarette Expectance Effects
Smoking helps me control my weight · Refuse to answer / Don't know
|
4 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 (Baseline)Population: Participants who completed the baseline survey
Assess frequency of use all of nicotine/tobacco products including cigars, cigarillos, little cigars, smokeless tobacco, EC, and hookah.
Outcome measures
| Measure |
E-cigarette
n=173 Participants
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=173 Participants
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Tobacco Use History Questionnaire
e-cigarette · Daily or almost daily
|
2 Participants
|
2 Participants
|
|
Tobacco Use History Questionnaire
e-cigarette · Less than daily, but at least once a week
|
6 Participants
|
2 Participants
|
|
Tobacco Use History Questionnaire
e-cigarette · Less than weekly, but at least once a month
|
13 Participants
|
7 Participants
|
|
Tobacco Use History Questionnaire
e-cigarette · Less than monthly
|
12 Participants
|
13 Participants
|
|
Tobacco Use History Questionnaire
e-cigarette · Not at all
|
139 Participants
|
149 Participants
|
|
Tobacco Use History Questionnaire
e-cigarette · Refuse to answer/Don't know
|
1 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire
Cigar · Daily or almost daily
|
1 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire
Cigar · Less than daily, but at least once a week
|
1 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire
Cigar · Less than weekly, but at least once a month
|
2 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire
Cigar · Less than monthly
|
11 Participants
|
5 Participants
|
|
Tobacco Use History Questionnaire
Cigar · Not at all
|
158 Participants
|
166 Participants
|
|
Tobacco Use History Questionnaire
Cigar · Refuse to answer/Don't know
|
0 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire
Cigarillo · Daily or almost daily
|
2 Participants
|
3 Participants
|
|
Tobacco Use History Questionnaire
Cigarillo · Less than daily, but at least once a week
|
5 Participants
|
5 Participants
|
|
Tobacco Use History Questionnaire
Cigarillo · Less than weekly, but at least once a month
|
7 Participants
|
2 Participants
|
|
Tobacco Use History Questionnaire
Cigarillo · Less than monthly
|
8 Participants
|
9 Participants
|
|
Tobacco Use History Questionnaire
Cigarillo · Not at all
|
151 Participants
|
153 Participants
|
|
Tobacco Use History Questionnaire
Cigarillo · Refuse to answer/Don't know
|
0 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire
Little Cigar · Daily or almost daily
|
2 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire
Little Cigar · Less than daily, but at least once a week
|
1 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire
Little Cigar · Less than weekly, but at least once a month
|
0 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire
Little Cigar · Less than monthly
|
5 Participants
|
3 Participants
|
|
Tobacco Use History Questionnaire
Little Cigar · Not at all
|
165 Participants
|
168 Participants
|
|
Tobacco Use History Questionnaire
Little Cigar · Refuse to answer/Don't know
|
0 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire
Smokeless Tobacco · Daily or almost daily
|
4 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire
Smokeless Tobacco · Less than daily, but at least once a week
|
1 Participants
|
4 Participants
|
|
Tobacco Use History Questionnaire
Smokeless Tobacco · Less than weekly, but at least once a month
|
0 Participants
|
3 Participants
|
|
Tobacco Use History Questionnaire
Smokeless Tobacco · Less than monthly
|
2 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire
Smokeless Tobacco · Not at all
|
166 Participants
|
164 Participants
|
|
Tobacco Use History Questionnaire
Smokeless Tobacco · Refuse to answer/Don't know
|
0 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire
Hookah · Daily or almost daily
|
0 Participants
|
0 Participants
|
|
Tobacco Use History Questionnaire
Hookah · Less than daily, but at least once a week
|
0 Participants
|
1 Participants
|
|
Tobacco Use History Questionnaire
Hookah · Less than weekly, but at least once a month
|
0 Participants
|
2 Participants
|
|
Tobacco Use History Questionnaire
Hookah · Less than monthly
|
0 Participants
|
2 Participants
|
|
Tobacco Use History Questionnaire
Hookah · Not at all
|
172 Participants
|
168 Participants
|
|
Tobacco Use History Questionnaire
Hookah · Refuse to answer/Don't know
|
1 Participants
|
0 Participants
|
Adverse Events
E-cigarette
Serious events: 18 serious events
Other events: 93 other events
Deaths: 0 deaths
Treatment As Usual
Serious events: 10 serious events
Other events: 87 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
E-cigarette
n=175 participants at risk
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=175 participants at risk
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Reproductive system and breast disorders
Breast Cancer
|
1.1%
2/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Difficulties
|
2.3%
4/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Broken Back
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Surgical and medical procedures
Carotid Endarterectomy Surgery
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Cardiac disorders
Chest Pain
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
General disorders
Chest Pain
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Blood and lymphatic system disorders
Cuff Repair Surgery
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Surgical and medical procedures
Dental Problems
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Nervous system disorders
Essential Tremor Worsening
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Exploratory Larynx Surgery
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Hepatobiliary disorders
Gallbladder Problems
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Problems
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Cardiac disorders
Heart Condition
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Cardiac disorders
Heart Palpitations
|
0.57%
1/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Surgical and medical procedures
Hernia
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Cardiac disorders
Myocardial Infarction
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Psychiatric disorders
Needed Medication Adjustment for Bipolar Schizoaffective Disorder
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Gastrointestinal disorders
Pancreatic Pain
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Nervous system disorders
Seizure
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Psychiatric disorders
Suicidal Thoughts
|
0.57%
1/175 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Gastrointestinal disorders
Ulcer
|
0.00%
0/175 • 12 weeks
|
1.1%
2/175 • 12 weeks
|
|
Infections and infestations
Wound Abscess
|
0.57%
1/175 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
Other adverse events
| Measure |
E-cigarette
n=175 participants at risk
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.
JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
|
Treatment As Usual
n=175 participants at risk
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.
Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
|
|---|---|---|
|
Immune system disorders
Allergies
|
1.1%
2/175 • 12 weeks
|
12.0%
21/175 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Difficulties
|
5.1%
9/175 • 12 weeks
|
4.0%
7/175 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.7%
52/175 • 12 weeks
|
9.7%
17/175 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
5.7%
10/175 • 12 weeks
|
13.1%
23/175 • 12 weeks
|
|
Blood and lymphatic system disorders
Headache
|
11.4%
20/175 • 12 weeks
|
13.1%
23/175 • 12 weeks
|
|
Gastrointestinal disorders
Mouth or Tongue Sores or Inflammation
|
5.7%
10/175 • 12 weeks
|
8.0%
14/175 • 12 weeks
|
|
Psychiatric disorders
Sleeplessness
|
5.1%
9/175 • 12 weeks
|
12.0%
21/175 • 12 weeks
|
|
Gastrointestinal disorders
Sore or Dry Mouth and Throat
|
26.3%
46/175 • 12 weeks
|
20.6%
36/175 • 12 weeks
|
|
Nervous system disorders
Sleepiness
|
2.9%
5/175 • 12 weeks
|
6.3%
11/175 • 12 weeks
|
|
Nervous system disorders
Sleeplessness
|
2.9%
5/175 • 12 weeks
|
6.9%
12/175 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place