Trial Outcomes & Findings for Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation (NCT NCT01406223)
NCT ID: NCT01406223
Last Updated: 2017-11-14
Results Overview
Mean blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) cue-reactivity signal following 2 week pre-quit treatment, controlling for baseline cue-reactivity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
282 participants
Primary outcome timeframe
change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) images collected during a cue-reactivity task following 2 weeks of pre-quit treatment
Results posted on
2017-11-14
Participant Flow
Of the 282 participants who were consented and screened, 191 were screen fails, 2 withdrew voluntarily before being assigned to a study arm, and 13 were lost to contact between screening and the first study visit. Therefore, only 76 participants were randomized and started the study.
Participant milestones
| Measure |
Varenicline
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch
|
NRT (Nicotine Patches Only)
21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
|
Varenicline + Bupropion
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch
|
Post-quit NRT
Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
20
|
19
|
|
Overall Study
COMPLETED
|
6
|
7
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
18
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Varenicline
n=18 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch
|
NRT (Nicotine Patches Only)
n=19 Participants
21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
|
Varenicline + Bupropion
n=20 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch
|
Post-quit NRT
n=19 Participants
Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
37.56 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
41.89 years
STANDARD_DEVIATION 12.22 • n=7 Participants
|
38.35 years
STANDARD_DEVIATION 11.42 • n=5 Participants
|
37.16 years
STANDARD_DEVIATION 10.59 • n=4 Participants
|
38.75 years
STANDARD_DEVIATION 11.19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
71 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
20 participants
n=5 Participants
|
19 participants
n=4 Participants
|
76 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) images collected during a cue-reactivity task following 2 weeks of pre-quit treatmentPopulation: Only participants who completed both scanning sessions and provided useable data were included in imaging analysis.
Mean blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) cue-reactivity signal following 2 week pre-quit treatment, controlling for baseline cue-reactivity.
Outcome measures
| Measure |
Varenicline
n=10 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch
|
NRT (Nicotine Patches Only)
n=13 Participants
21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
|
Varenicline + Bupropion
n=8 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch
|
Post-quit NRT
n=8 Participants
Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch
|
|---|---|---|---|---|
|
The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences
left amygdala
|
0.057 percent BOLD signal change
Standard Deviation 0.285
|
.007 percent BOLD signal change
Standard Deviation .186
|
.160 percent BOLD signal change
Standard Deviation .258
|
.129 percent BOLD signal change
Standard Deviation .278
|
|
The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences
right amydala
|
.051 percent BOLD signal change
Standard Deviation .337
|
-.014 percent BOLD signal change
Standard Deviation .190
|
.134 percent BOLD signal change
Standard Deviation .266
|
.020 percent BOLD signal change
Standard Deviation .249
|
|
The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences
left anterior insula
|
.094 percent BOLD signal change
Standard Deviation .196
|
.013 percent BOLD signal change
Standard Deviation .244
|
-.015 percent BOLD signal change
Standard Deviation .160
|
.179 percent BOLD signal change
Standard Deviation .288
|
|
The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences
right anterior insula
|
-.008 percent BOLD signal change
Standard Deviation .224
|
.065 percent BOLD signal change
Standard Deviation .305
|
.019 percent BOLD signal change
Standard Deviation .188
|
.082 percent BOLD signal change
Standard Deviation .333
|
|
The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences
left medial prefrontal cortex
|
.129 percent BOLD signal change
Standard Deviation .162
|
.026 percent BOLD signal change
Standard Deviation .294
|
-.120 percent BOLD signal change
Standard Deviation .562
|
.009 percent BOLD signal change
Standard Deviation .200
|
|
The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences
right medial prefrtonal cortex
|
.058 percent BOLD signal change
Standard Deviation .171
|
-.010 percent BOLD signal change
Standard Deviation .277
|
-.176 percent BOLD signal change
Standard Deviation .641
|
-.017 percent BOLD signal change
Standard Deviation .178
|
SECONDARY outcome
Timeframe: Up to 11 weeks post quit day.Population: Twenty-eight subjects dropped from the study prior to their scheduled quit day, so they were not included in these analyses.
Days to first cigarette (i.e. lapse) will be measured via self-report.
Outcome measures
| Measure |
Varenicline
n=13 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch
|
NRT (Nicotine Patches Only)
n=14 Participants
21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
|
Varenicline + Bupropion
n=10 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch
|
Post-quit NRT
n=11 Participants
Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch
|
|---|---|---|---|---|
|
Days to First Cigarette Following Quitting Smoking
|
9.15 days
Standard Deviation 22.143
|
15.21 days
Standard Deviation 26.066
|
9.90 days
Standard Deviation 23.960
|
5.73 days
Standard Deviation 18.666
|
Adverse Events
Varenicline
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
NRT (Nicotine Patches Only)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Varenicline + Bupropion
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Post-quit NRT
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline
n=18 participants at risk
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch
|
NRT (Nicotine Patches Only)
n=19 participants at risk
21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
|
Varenicline + Bupropion
n=20 participants at risk
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch
|
Post-quit NRT
n=19 participants at risk
Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
10.0%
2/20 • Number of events 2 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
10.5%
2/19 • Number of events 3 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Nervous system disorders
Excessive Sweating
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
General disorders
Dry Mouth
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
10.5%
2/19 • Number of events 7 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.0%
1/20 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
10.5%
2/19 • Number of events 3 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
General disorders
Thirst
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
10.5%
2/19 • Number of events 7 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
15.8%
3/19 • Number of events 5 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
General disorders
Hiccups
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
11.1%
2/18 • Number of events 4 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
10.5%
2/19 • Number of events 2 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
15.0%
3/20 • Number of events 3 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 2 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Musculoskeletal and connective tissue disorders
Joint/Muscle Pain
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
15.8%
3/19 • Number of events 7 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Nervous system disorders
Irritability
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
15.0%
3/20 • Number of events 3 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Nervous system disorders
Nightmares
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 3 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Nervous system disorders
Vivid Dreams
|
11.1%
2/18 • Number of events 3 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
15.0%
3/20 • Number of events 6 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
15.8%
3/19 • Number of events 6 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Nervous system disorders
Insomnia
|
5.6%
1/18 • Number of events 2 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
15.8%
3/19 • Number of events 9 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
General disorders
Decreased Libido
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.0%
1/20 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Skin and subcutaneous tissue disorders
Itching/Burning at Patch Site
|
5.6%
1/18 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 2 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Skin and subcutaneous tissue disorders
Rash at Patch Site
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 2 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
General disorders
Mouth/Throat Irritation
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
|
Gastrointestinal disorders
Upset Stomach
|
5.6%
1/18 • Number of events 1 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/20 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
0.00%
0/19 • Subjects were receiving study drugs for 13 weeks.
At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place