Trial Outcomes & Findings for Translational Neuropsychopharmacology Research of Nicotine Addiction (NCT NCT02723162)
NCT ID: NCT02723162
Last Updated: 2022-08-18
Results Overview
Measure the Effects of Varenicline and N-Acetylcysteine (NAC) on brain activation to smoking images while participants undergo Functional Magnetic Resonance (fMRI) Imaging. Mean percent signal change of fMRI BOLD in the insula and nucleus accumbens will be recorded during smoking images. The lower the BOLD signal response, the better the outcome, meaning reduced reactivity to smoking images.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
10 Days
Results posted on
2022-08-18
Participant Flow
Participant milestones
| Measure |
VRN+ NAC
Titrated VRN up to 1mg BID with NAC at 1200mg BID for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
|
NAC+ PBO
1200mg BID for 28 days plus VRN placebo for 28 days
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
Placebo: Matched placebo
|
VRN+ PBO
Titrated VRN up to 1mg BID with NAC placebo for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
Placebo: Matched placebo
|
PBO+PBO
Double placebo taken for 28 days
Placebo: Matched placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
17
|
17
|
|
Overall Study
Day 10 fMRI Visit
|
15
|
11
|
14
|
15
|
|
Overall Study
COMPLETED
|
12
|
10
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Translational Neuropsychopharmacology Research of Nicotine Addiction
Baseline characteristics by cohort
| Measure |
Total
n=67 Participants
Total of all reporting groups
|
VRN+ NAC
n=18 Participants
Titrated VRN up to 1mg BID with NAC at 1200mg BID for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
|
NAC+ PBO
n=15 Participants
1200mg BID for 28 days plus VRN placebo for 28 days
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
Placebo: Matched placebo
|
VRN+ PBO
n=17 Participants
Titrated VRN up to 1mg BID with NAC placebo for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
Placebo: Matched placebo
|
PBO+PBO
n=17 Participants
Double placebo taken for 28 days
Placebo: Matched placebo
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=36 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=36 Participants
|
18 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=36 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 10.7 • n=36 Participants
|
43.6 years
STANDARD_DEVIATION 8.9 • n=93 Participants
|
35.1 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
42.4 years
STANDARD_DEVIATION 9.8 • n=27 Participants
|
37.1 years
STANDARD_DEVIATION 9.6 • n=483 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=36 Participants
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=36 Participants
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=36 Participants
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=36 Participants
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=36 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=36 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=36 Participants
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=36 Participants
|
12 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=36 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=36 Participants
|
18 participants
n=93 Participants
|
15 participants
n=4 Participants
|
17 participants
n=27 Participants
|
17 participants
n=483 Participants
|
|
Cigarettes Smoked Per Day
|
17.3 Cigarettes Per Day
STANDARD_DEVIATION 11.6 • n=36 Participants
|
16.8 Cigarettes Per Day
STANDARD_DEVIATION 12.6 • n=93 Participants
|
13.7 Cigarettes Per Day
STANDARD_DEVIATION 10.4 • n=4 Participants
|
17.3 Cigarettes Per Day
STANDARD_DEVIATION 11.4 • n=27 Participants
|
20.0 Cigarettes Per Day
STANDARD_DEVIATION 19.2 • n=483 Participants
|
PRIMARY outcome
Timeframe: 10 DaysMeasure the Effects of Varenicline and N-Acetylcysteine (NAC) on brain activation to smoking images while participants undergo Functional Magnetic Resonance (fMRI) Imaging. Mean percent signal change of fMRI BOLD in the insula and nucleus accumbens will be recorded during smoking images. The lower the BOLD signal response, the better the outcome, meaning reduced reactivity to smoking images.
Outcome measures
| Measure |
VRN+ NAC
n=15 Participants
Titrated VRN up to 1mg BID with NAC at 1200mg BID for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
|
NAC+ PBO
n=11 Participants
1200mg BID for 28 days plus VRN placebo for 28 days
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
Placebo: Matched placebo
|
VRN+ PBO
n=14 Participants
Titrated VRN up to 1mg BID with NAC placebo for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
Placebo: Matched placebo
|
PBO+PBO
n=15 Participants
Double placebo taken for 28 days
Placebo: Matched placebo
|
|---|---|---|---|---|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Signal Response
Insula
|
-0.09 Percentage change
Interval -1.14 to 0.77
|
1.07 Percentage change
Interval 0.39 to 1.41
|
0.08 Percentage change
Interval -0.36 to 0.33
|
1.19 Percentage change
Interval 0.78 to 2.84
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Signal Response
Nucleus Accumbens
|
0.11 Percentage change
Interval -0.25 to 0.67
|
0.91 Percentage change
Interval -0.15 to 1.81
|
0.12 Percentage change
Interval -0.81 to 1.1
|
1.43 Percentage change
Interval 0.94 to 2.25
|
PRIMARY outcome
Timeframe: Baseline to day 10Measure the effects of Varenicline and N-Acetylcysteine on resting-state functional connectivity while participants undergo fMRI. Fisher transformed correlation (rZ) scores will be recorded between medial prefrontal cortex and ventral striatum during a resting state scan. The higher the rZ score, the better the outcome, meaning stronger functional connectivity. rZ scores range from -1 to 1. The rZ-score central value is analogous to a central value to of a Z-score of 0, representing the population mean.
Outcome measures
| Measure |
VRN+ NAC
n=16 Participants
Titrated VRN up to 1mg BID with NAC at 1200mg BID for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
|
NAC+ PBO
n=14 Participants
1200mg BID for 28 days plus VRN placebo for 28 days
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
Placebo: Matched placebo
|
VRN+ PBO
n=11 Participants
Titrated VRN up to 1mg BID with NAC placebo for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
Placebo: Matched placebo
|
PBO+PBO
n=15 Participants
Double placebo taken for 28 days
Placebo: Matched placebo
|
|---|---|---|---|---|
|
rZ Change Score in Resting State Functional Connectivity From Baseline
|
.297 Fisher Z
Standard Error .053
|
.060 Fisher Z
Standard Error .042
|
.181 Fisher Z
Standard Error .053
|
.191 Fisher Z
Standard Error .058
|
SECONDARY outcome
Timeframe: 28 DaysPopulation: Analysis population consists of randomized participants that had data available at study day 7 or beyond.
Measure the effects of Varenicline and N-Acetylcysteine on smoking behavior over the course of the study
Outcome measures
| Measure |
VRN+ NAC
n=15 Participants
Titrated VRN up to 1mg BID with NAC at 1200mg BID for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
|
NAC+ PBO
n=13 Participants
1200mg BID for 28 days plus VRN placebo for 28 days
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
Placebo: Matched placebo
|
VRN+ PBO
n=14 Participants
Titrated VRN up to 1mg BID with NAC placebo for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
Placebo: Matched placebo
|
PBO+PBO
n=16 Participants
Double placebo taken for 28 days
Placebo: Matched placebo
|
|---|---|---|---|---|
|
Number of Cigarettes Smoked Per Day
|
5.3 Cigarettes per day
Standard Deviation 5.5
|
4.0 Cigarettes per day
Standard Deviation 4.8
|
5.3 Cigarettes per day
Standard Deviation 3.9
|
5.0 Cigarettes per day
Standard Deviation 4.5
|
Adverse Events
VRN+ NAC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
NAC+ PBO
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
VRN+ PBO
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PBO+PBO
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VRN+ NAC
n=18 participants at risk
Titrated VRN up to 1mg BID with NAC at 1200mg BID for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
|
NAC+ PBO
n=15 participants at risk
1200mg BID for 28 days plus VRN placebo for 28 days
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
Placebo: Matched placebo
|
VRN+ PBO
n=17 participants at risk
Titrated VRN up to 1mg BID with NAC placebo for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
Placebo: Matched placebo
|
PBO+PBO
n=17 participants at risk
Double placebo taken for 28 days
Placebo: Matched placebo
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
|
Hepatobiliary disorders
Choleithiasis (worsening)
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
Other adverse events
| Measure |
VRN+ NAC
n=18 participants at risk
Titrated VRN up to 1mg BID with NAC at 1200mg BID for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
|
NAC+ PBO
n=15 participants at risk
1200mg BID for 28 days plus VRN placebo for 28 days
N-Acetylcysteine (NAC): NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
Placebo: Matched placebo
|
VRN+ PBO
n=17 participants at risk
Titrated VRN up to 1mg BID with NAC placebo for 28 days
Varenicline (VRN): VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
Placebo: Matched placebo
|
PBO+PBO
n=17 participants at risk
Double placebo taken for 28 days
Placebo: Matched placebo
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • 35 days
|
26.7%
4/15 • Number of events 4 • 35 days
|
0.00%
0/17 • 35 days
|
23.5%
4/17 • Number of events 5 • 35 days
|
|
Vascular disorders
Flushing
|
0.00%
0/18 • 35 days
|
6.7%
1/15 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • 35 days
|
6.7%
1/15 • Number of events 1 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
5.9%
1/17 • Number of events 2 • 35 days
|
|
Injury, poisoning and procedural complications
Eye Injury
|
0.00%
0/18 • 35 days
|
6.7%
1/15 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Gastrointestinal disorders
Food Poisoning
|
5.6%
1/18 • Number of events 1 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Psychiatric disorders
Depressed Mood
|
5.6%
1/18 • Number of events 1 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
|
Psychiatric disorders
Anxiety (Worsening)
|
0.00%
0/18 • 35 days
|
6.7%
1/15 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
11.8%
2/17 • Number of events 2 • 35 days
|
|
General disorders
Irritability
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
|
General disorders
Increased Energy
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
|
General disorders
Constipation
|
5.6%
1/18 • Number of events 1 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • Number of events 1 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
11.8%
2/17 • Number of events 2 • 35 days
|
|
Injury, poisoning and procedural complications
Post Operative Pain
|
0.00%
0/18 • 35 days
|
6.7%
1/15 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Skin and subcutaneous tissue disorders
Rash, Generalized
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/18 • 35 days
|
6.7%
1/15 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
|
Psychiatric disorders
Agitation
|
0.00%
0/18 • 35 days
|
6.7%
1/15 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Psychiatric disorders
Somnambulism
|
5.6%
1/18 • Number of events 1 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Nervous system disorders
Headache (worsening)
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
11.8%
2/17 • Number of events 2 • 35 days
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Number of events 1 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 2 • 35 days
|
|
Nervous system disorders
Poor Quality Sleep
|
5.6%
1/18 • Number of events 1 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/18 • 35 days
|
6.7%
1/15 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain (Worsening)
|
0.00%
0/18 • 35 days
|
6.7%
1/15 • Number of events 1 • 35 days
|
0.00%
0/17 • 35 days
|
0.00%
0/17 • 35 days
|
|
Psychiatric disorders
Psychological Trauma
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/18 • 35 days
|
0.00%
0/15 • 35 days
|
0.00%
0/17 • 35 days
|
5.9%
1/17 • Number of events 1 • 35 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place