Trial Outcomes & Findings for Stress Neuroadaptation in Tobacco Dependence (NCT NCT03262233)
NCT ID: NCT03262233
Last Updated: 2019-04-23
Results Overview
The average of unpredictable startle potentiation and predictable startle potentiation during the first administration of the NPU stressor task.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
226 participants
Primary outcome timeframe
up to 24 hours after start of cessation attempt (deprived groups); during normal smoking prior to quit attempt, ie. Baseline (non-deprived groups)
Results posted on
2019-04-23
Participant Flow
Participant milestones
| Measure |
Active Deprived
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Active Non-Deprived
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
Placebo Deprived
Placebo patches and placebo lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Placebo Non-deprived
Placebo patches and placebo lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
59
|
61
|
|
Overall Study
COMPLETED
|
35
|
32
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
18
|
21
|
25
|
29
|
Reasons for withdrawal
| Measure |
Active Deprived
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Active Non-Deprived
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
Placebo Deprived
Placebo patches and placebo lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Placebo Non-deprived
Placebo patches and placebo lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
8
|
21
|
13
|
|
Overall Study
Declined due to shock
|
1
|
2
|
2
|
3
|
|
Overall Study
Protocol Violation
|
5
|
10
|
2
|
13
|
|
Overall Study
data collection artifact
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Stress Neuroadaptation in Tobacco Dependence
Baseline characteristics by cohort
| Measure |
Active Deprived
n=35 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Active Non-Deprived
n=32 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
Placebo Deprived
n=34 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Placebo Non-Deprived
n=32 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
42 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
40 years
STANDARD_DEVIATION 11.65 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
131 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
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
01 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 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
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 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
|
35 participants
n=5 Participants
|
32 participants
n=7 Participants
|
34 participants
n=5 Participants
|
32 participants
n=4 Participants
|
133 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 24 hours after start of cessation attempt (deprived groups); during normal smoking prior to quit attempt, ie. Baseline (non-deprived groups)The average of unpredictable startle potentiation and predictable startle potentiation during the first administration of the NPU stressor task.
Outcome measures
| Measure |
Active Deprived
n=35 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Active Non-deprived
n=32 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
Placebo Deprived
n=34 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Placebo Non-deprived
n=32 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
|---|---|---|---|---|
|
Overall Stressor Reactivity
|
25.1 microvolts
Standard Deviation 23.0
|
22.5 microvolts
Standard Deviation 24.4
|
32.3 microvolts
Standard Deviation 29.6
|
16.9 microvolts
Standard Deviation 17.7
|
PRIMARY outcome
Timeframe: up to 24 hours post cessation attempt (deprived groups); during normal smoking prior to quit attempt, ie. Baseline (non-deprived groups)Unpredictable startle potentiation minus predictable startle potentiation during the first administration of the NPU stressor task
Outcome measures
| Measure |
Active Deprived
n=35 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Active Non-deprived
n=32 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
Placebo Deprived
n=34 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Placebo Non-deprived
n=32 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
|---|---|---|---|---|
|
Relative Unpredictable Stressor Reactivity
|
-6.77 microvolts
Standard Deviation 14.0
|
-7.91 microvolts
Standard Deviation 14.4
|
-6.06 microvolts
Standard Deviation 12.3
|
-4.99 microvolts
Standard Deviation 14.0
|
PRIMARY outcome
Timeframe: baseline and up to 14 days post cessation attempt (non-deprived groups); baseline and up to 24 hours post quit attempt (deprived groups)A difference score of overall stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task
Outcome measures
| Measure |
Active Deprived
n=35 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Active Non-deprived
n=32 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
Placebo Deprived
n=34 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Placebo Non-deprived
n=32 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
|---|---|---|---|---|
|
Change in Overall Stressor Reactivity
|
-2.94 change in microvolts
Standard Deviation 16.3
|
0.929 change in microvolts
Standard Deviation 13.0
|
-10.3 change in microvolts
Standard Deviation 24.0
|
4.78 change in microvolts
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: baseline and up to 14 days post cessation attempt (non-deprived groups); baseline and up to 24 hours post quit attempt (deprived groups)A difference score of relative unpredictable stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task
Outcome measures
| Measure |
Active Deprived
n=35 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Active Non-deprived
n=32 Participants
21 mg nicotine patches and 2 mg nicotine lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
Placebo Deprived
n=34 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place 24 hours after start of quit attempt
|
Placebo Non-deprived
n=32 Participants
Placebo patches and placebo lozenges
\+ First NPU task takes place during normal smoking prior to quit attempt
|
|---|---|---|---|---|
|
Change in Relative Unpredictable Stressor Reactivity
|
1.95 change in microvolts
Standard Deviation 15.5
|
3.99 change in microvolts
Standard Deviation 14.8
|
0.889 change in microvolts
Standard Deviation 16.0
|
-1.35 change in microvolts
Standard Deviation 11.3
|
Adverse Events
Active Deprived
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Non-deprived
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Deprived
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Non-deprived
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place