Trial Outcomes & Findings for Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia (NCT NCT03838484)

Last Updated: 2022-04-29

Results Overview

Participants will be shown fearful, sad, angry, and disgust faces (negative valence) and neutral faces performed in 5 blocks (3 emotional blocks with angry/fearful/sad/disgust faces and 2 non-emotional blocks). In each block the subject is instructed on the go/no-go targets and will press a key ("Go") or withhold pressing a key ("NoGo"). The False Alarm Error Rate will be measured by the proportion of incorrect responses.

Recruitment status

TERMINATED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Week 1

Results posted on

2022-04-29

Participant Flow

1 participant lost to follow-up

Participant milestones

Participant milestones
Measure	Healthy: Placebo First, Nicotine Last Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.	Healthy: Nicotine First, Placebo Last Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.	SCZ: Placebo First, Nicotine Last Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.	SCZ: Nicotine First, Placebo Last Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
Overall Study STARTED	5	5	4	4
Overall Study COMPLETED	5	4	4	4
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy: Placebo First, Nicotine Last Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.	Healthy: Nicotine First, Placebo Last Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.	SCZ: Placebo First, Nicotine Last Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.	SCZ: Nicotine First, Placebo Last Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
Overall Study Lost to Follow-up	0	1	0	0

Baseline Characteristics

Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy: Placebo First, Nicotine Last n=5 Participants Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.	Healthy: Nicotine First, Placebo Last n=4 Participants Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.	SCZ: Placebo First, Nicotine Last n=4 Participants Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.	SCZ: Nicotine First, Placebo Last n=4 Participants Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.	Total n=17 Participants Total of all reporting groups
Age, Continuous	29 years STANDARD_DEVIATION 4 • n=99 Participants	38 years STANDARD_DEVIATION 11 • n=107 Participants	33 years STANDARD_DEVIATION 15 • n=206 Participants	26 years STANDARD_DEVIATION 5 • n=7 Participants	33 years STANDARD_DEVIATION 9 • n=31 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	5 Participants n=31 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=7 Participants	12 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	2 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	4 Participants n=7 Participants	15 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	3 Participants n=31 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants	4 Participants n=7 Participants	13 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Region of Enrollment United States	5 participants n=99 Participants	4 participants n=107 Participants	4 participants n=206 Participants	4 participants n=7 Participants	17 participants n=31 Participants

PRIMARY outcome

Timeframe: Week 1

Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 1. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 1.

Outcome measures

Outcome measures
Measure	Healthy: Placebo n=5 Participants Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	Healthy: Nicotine n=4 Participants Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Placebo n=4 Participants Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Nicotine n=4 Participants Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
False Alarm Error Rate	0.20 Proportion of incorrect responses Standard Error 0.05	0.15 Proportion of incorrect responses Standard Error 0.07	0.11 Proportion of incorrect responses Standard Error 0.04	0.19 Proportion of incorrect responses Standard Error 0.05

PRIMARY outcome

Timeframe: Week 2

Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 2. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 2.

Outcome measures

Outcome measures
Measure	Healthy: Placebo n=5 Participants Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	Healthy: Nicotine n=4 Participants Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Placebo n=4 Participants Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Nicotine n=4 Participants Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
False Alarm Error Rate	0.18 Proportion of incorrect responses Standard Error 0.03	0.13 Proportion of incorrect responses Standard Error 0.06	0.15 Proportion of incorrect responses Standard Error 0.02	0.23 Proportion of incorrect responses Standard Error 0.04

PRIMARY outcome

Timeframe: Week 1

Participants will be shown fearful, sad, angry, and disgust faces (negative valence) and neutral faces performed in 5 blocks (3 emotional blocks with angry/fearful/sad/disgust faces and 2 non-emotional blocks). In each block the subject is instructed on the go/no-go targets and will press a key ("Go") or withhold pressing a key ("NoGo"). The Omission Error Rate will be measured by the proportion of questions asked with a failure to respond.

Outcome measures

Outcome measures
Measure	Healthy: Placebo n=5 Participants Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	Healthy: Nicotine n=4 Participants Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Placebo n=4 Participants Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Nicotine n=4 Participants Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
Omission Error Rate	0.24 Proportion of omitted responses Standard Error 0.04	0.29 Proportion of omitted responses Standard Error 0.06	0.44 Proportion of omitted responses Standard Error 0.06	0.27 Proportion of omitted responses Standard Error 0.03

PRIMARY outcome

Timeframe: Week 2

Participants will be shown fearful, sad, angry, and disgust faces (negative valence) and neutral faces performed in 5 blocks (3 emotional blocks with angry/fearful/sad/disgust faces and 2 non-emotional blocks). In each block the subject is instructed on the go/no-go targets and will press a key ("Go") or withhold pressing a key ("NoGo"). The Omission Error Rate will be measured by the proportion of questions asked with a failure to respond.

Outcome measures

Outcome measures
Measure	Healthy: Placebo n=5 Participants Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	Healthy: Nicotine n=4 Participants Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Placebo n=4 Participants Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Nicotine n=4 Participants Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
Omission Error Rate	0.29 Proportion of omitted responses Standard Error 0.07	0.23 Proportion of omitted responses Standard Error 0.06	0.38 Proportion of omitted responses Standard Error 0.10	0.30 Proportion of omitted responses Standard Error 0.03

PRIMARY outcome

Timeframe: Week 1

Time taken from stimulus presentation to button push during Go trials

Outcome measures

Outcome measures
Measure	Healthy: Placebo n=5 Participants Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	Healthy: Nicotine n=4 Participants Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Placebo n=4 Participants Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Nicotine n=4 Participants Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
Reaction Time for Correct Hits	485.09 Milliseconds Standard Error 16.56	491.05 Milliseconds Standard Error 16.50	468.96 Milliseconds Standard Error 13.49	517.05 Milliseconds Standard Error 4.66

PRIMARY outcome

Timeframe: Week 2

Time taken from stimulus presentation to button push during Go trials

Outcome measures

Outcome measures
Measure	Healthy: Placebo n=5 Participants Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	Healthy: Nicotine n=4 Participants Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Placebo n=4 Participants Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Nicotine n=4 Participants Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
Reaction Time for Correct Hits	477.54 Milliseconds Standard Error 15.06	511.10 Milliseconds Standard Error 10.88	478.99 Milliseconds Standard Error 18.36	490.67 Milliseconds Standard Error 24.40

PRIMARY outcome

Timeframe: Week 1

Time taken from stimulus presentation to button push during NoGo trials

Outcome measures

Outcome measures
Measure	Healthy: Placebo n=5 Participants Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	Healthy: Nicotine n=4 Participants Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Placebo n=4 Participants Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Nicotine n=4 Participants Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
Reaction Time for False Alarms	718.89 Milliseconds Standard Error 36.52	658.20 Milliseconds Standard Error 40.50	813.00 Milliseconds Standard Error 48.83	692.95 Milliseconds Standard Error 31.27

PRIMARY outcome

Timeframe: Week 2

Time taken from stimulus presentation to button push during NoGo trials

Outcome measures

Outcome measures
Measure	Healthy: Placebo n=5 Participants Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	Healthy: Nicotine n=4 Participants Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Placebo n=4 Participants Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.	SCZ: Nicotine n=4 Participants Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
Reaction Time for False Alarms	727.30 Milliseconds Standard Error 60.81	758.12 Milliseconds Standard Error 69.68	769.95 Milliseconds Standard Error 42.67	703.99 Milliseconds Standard Error 23.82

Adverse Events

Healthy: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Healthy: Nicotine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

SCZ: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

SCZ: Nicotine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy: Placebo n=10 participants at risk Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task.	Healthy: Nicotine n=10 participants at risk Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task.	SCZ: Placebo n=8 participants at risk Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task.	SCZ: Nicotine n=8 participants at risk Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task.
Eye disorders Blurry vision	0.00% 0/10 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	30.0% 3/10 • Number of events 3 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	12.5% 1/8 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	12.5% 1/8 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
Skin and subcutaneous tissue disorders Sweating	10.0% 1/10 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	20.0% 2/10 • Number of events 2 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
Gastrointestinal disorders Dry mouth	10.0% 1/10 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	10.0% 1/10 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	12.5% 1/8 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
Gastrointestinal disorders Nausea	0.00% 0/10 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	20.0% 2/10 • Number of events 2 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	12.5% 1/8 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
Gastrointestinal disorders Increased salivation	0.00% 0/10 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/10 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	12.5% 1/8 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
Nervous system disorders Dizziness	0.00% 0/10 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	10.0% 1/10 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	12.5% 1/8 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
Renal and urinary disorders Increased urination	0.00% 0/10 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	10.0% 1/10 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
Cardiac disorders Heart palpitations	0.00% 0/10 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	10.0% 1/10 • Number of events 1 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.	0.00% 0/8 • 30 minutes following removal of patch on each session day. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.

Additional Information

Alan S. Lewis, M.D., Ph.D.

Vanderbilt University Medical Center

Phone: 615-875-4027

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place