Trial Outcomes & Findings for The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder (NCT NCT05711862)
NCT ID: NCT05711862
Last Updated: 2025-04-29
Results Overview
Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21, higher score indicating a worse outcome. The global PSQI score is reported.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
7 days
Results posted on
2025-04-29
Participant Flow
Of the 7 enrolled participants, 4 were randomized and 3 were lost to follow-up before randomization.
Participant milestones
| Measure |
1 Week Suvorexant (SUVO), Then 1 Week Placebo
After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
Placebo: Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo, Then 1 Week Suvorexant (SUVO)
After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
Placebo: Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
|---|---|---|
|
First Intervention (1 Week)
STARTED
|
2
|
2
|
|
First Intervention (1 Week)
Received Intervention
|
2
|
2
|
|
First Intervention (1 Week)
COMPLETED
|
2
|
1
|
|
First Intervention (1 Week)
NOT COMPLETED
|
0
|
1
|
|
Washout (1 Week)
STARTED
|
2
|
1
|
|
Washout (1 Week)
COMPLETED
|
2
|
1
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Week)
STARTED
|
2
|
1
|
|
Second Intervention (1 Week)
Received Intervention
|
2
|
1
|
|
Second Intervention (1 Week)
COMPLETED
|
2
|
1
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder
Baseline characteristics by cohort
| Measure |
1 Week Suvorexant (SUVO), Then 1 Week Placebo
n=2 Participants
After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
Placebo: Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo, Then 1 Week Suvorexant (SUVO)
n=2 Participants
After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
Placebo: Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 5 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Years of Education
|
12 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
13 years
STANDARD_DEVIATION 0 • n=7 Participants
|
12.5 years
STANDARD_DEVIATION 1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysEach component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21, higher score indicating a worse outcome. The global PSQI score is reported.
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)
|
8.66 score on a scale
Standard Deviation 2.88
|
9.66 score on a scale
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: 7 daysEEG will be used to assess electrical activity in the brain, specifically, to assess alpha power, which is the level of activity in the 8-12Hz frequency range. Resting state EEG means that EEG will be assessed during wakeful rest. Alpha power will be assessed in each of the 4 brain lobes (frontal, central, parietal, and occipital) for 3 minutes during eyes closed wakeful rest and also for 3 minutes during eyes open wakeful rest. Alpha Power will be reported in microvolts squared (μV²). Higher alpha power indicates more sleepiness and lower alpha power indicates less sleepiness
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Resting State Alpha Power as Assessed by EEG
Eyes closed - Fz (frontal)
|
-1.25 microvolts squared (μV²)
Standard Deviation 0.25
|
-1.12 microvolts squared (μV²)
Standard Deviation 0.57
|
|
Resting State Alpha Power as Assessed by EEG
Eyes closed - Cz (Central)
|
-2.04 microvolts squared (μV²)
Standard Deviation 0.52
|
-1.42 microvolts squared (μV²)
Standard Deviation 0.48
|
|
Resting State Alpha Power as Assessed by EEG
Eyes closed - Oz (occipital)
|
-1.19 microvolts squared (μV²)
Standard Deviation 0.49
|
-1.12 microvolts squared (μV²)
Standard Deviation 0.75
|
|
Resting State Alpha Power as Assessed by EEG
Eyes closed - Pz (parietal)
|
-2.08 microvolts squared (μV²)
Standard Deviation 0.27
|
-1.78 microvolts squared (μV²)
Standard Deviation 0.51
|
|
Resting State Alpha Power as Assessed by EEG
Eyes open - Fz (frontal)
|
-1.46 microvolts squared (μV²)
Standard Deviation 0.21
|
-1.25 microvolts squared (μV²)
Standard Deviation 0.27
|
|
Resting State Alpha Power as Assessed by EEG
Eyes open - Cz (Central)
|
-2.16 microvolts squared (μV²)
Standard Deviation 0.34
|
-1.64 microvolts squared (μV²)
Standard Deviation 0.44
|
|
Resting State Alpha Power as Assessed by EEG
Eyes open - Oz (occipital)
|
-1.55 microvolts squared (μV²)
Standard Deviation 0.27
|
-1.44 microvolts squared (μV²)
Standard Deviation 0.71
|
|
Resting State Alpha Power as Assessed by EEG
Eyes open - Pz (parietal)
|
-2.36 microvolts squared (μV²)
Standard Deviation 0.34
|
-1.83 microvolts squared (μV²)
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: 7 daysThe Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and Methamphetamine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG
LPP Amplitude with Pleasant Images
|
2.85 microvolts
Standard Deviation 0.96
|
1.60 microvolts
Standard Deviation 2.27
|
|
Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG
LPP Amplitude with Unpleasant Image
|
1.90 microvolts
Standard Deviation 1.33
|
1.38 microvolts
Standard Deviation 1.37
|
|
Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG
LPP Amplitude with Methamphetamine Images
|
1.62 microvolts
Standard Deviation 0.40
|
1.08 microvolts
Standard Deviation 0.27
|
|
Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG
LPP Amplitude with Neutral Images
|
1.01 microvolts
Standard Deviation 0.85
|
0.67 microvolts
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: 7 daysThe Stress Subscale of the Depression, Anxiety and Stress scale (DASS-21) assesses stress levels. Total score on the DASS-21 stress subscale ranges from 0 to 21, with a higher score indicating greater stress.
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21)
|
7.67 score on a scale
Standard Deviation 6.03
|
8.33 score on a scale
Standard Deviation 8.50
|
PRIMARY outcome
Timeframe: 7 daysThe Visual Analog Scale is scored from 0-10, with 0 being no stress, 10 being extreme stress.
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Self-reported Stress as Assessed by the Visual Analog Scale (VAS)
|
2.33 score on a scale
Standard Deviation 3.21
|
5.67 score on a scale
Standard Deviation 5.13
|
PRIMARY outcome
Timeframe: baseline, about 32 minutes after the start of the cold pressor taskDuring the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Change of Cortisol Level
|
2103.99 picograms per milliliter (pg/mL)
Standard Deviation 4226.09
|
233.55 picograms per milliliter (pg/mL)
Standard Deviation 1225.26
|
PRIMARY outcome
Timeframe: 7 daysThe average sleep time per night (averaged over 7 days) will be reported.
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights
|
326.52 minutes per night
Standard Deviation 113.90
|
303.14 minutes per night
Standard Deviation 89.44
|
PRIMARY outcome
Timeframe: 7 daysThe average time awake after sleep onset per night (averaged over 7 days) will be reported.
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Average Time Awake After Sleep Onset Measured Nightly Via Actigraphy Watch Over 7 Nights
|
54.07 minutes per night
Standard Deviation 20.13
|
44.89 minutes per night
Standard Deviation 15.16
|
SECONDARY outcome
Timeframe: 7 daysTimeline Followback (TLFB) is a method to assess Methamphetamine use that involves asking study participants to self-report their Methamphetamine use over the past week.
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method
|
2.67 days
Standard Deviation 2.52
|
3.33 days
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: Day 7Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Number of Participants Who Had Side Effects
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 7 daysBeck's Depression Inventory (BDI)scale total score ranges from 0 to 63, higher score indicating more depression
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Depression as Assessed by the Beck's Depression Inventory (BDI)Scale
|
9.33 score on a scale
Standard Deviation 3.06
|
25.00 score on a scale
Standard Deviation 27.18
|
SECONDARY outcome
Timeframe: 7 daysThis is a semi-structured interview that measures suicide ideation on a 6-point ordinal scale, ranging from 0 (no suicide ideation) to 5 (suicidal intent with plan) with a higher score indicating worse outcome
Outcome measures
| Measure |
1 Week SUVO
n=3 Participants
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=3 Participants
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM
|
|---|---|---|
|
Suicidal Ideation and Behavior as Assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR)
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
Adverse Events
1 Week Suvorexant (SUVO)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1 Week Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 Week Suvorexant (SUVO)
n=4 participants at risk
suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
1 Week Placebo
n=4 participants at risk
Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
|---|---|---|
|
Nervous system disorders
Drowsiness
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Not Sleeping Well
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
75.0%
3/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Nervousness
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Sweating
|
75.0%
3/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Cloudiness
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Memory Loss
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Fatigue Tiredness
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Difficulty Walking
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Weakness
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Nervous system disorders
Heart Racing
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Gastrointestinal disorders
Stomach Cramps
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
3/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Renal and urinary disorders
Increased Urination
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
General disorders
Dry Mouth
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Immune system disorders
Fever or Chills
|
50.0%
2/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
0.00%
0/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
25.0%
1/4 • Up to 3 weeks
Includes all participants who were randomized and received intervention.
|
Additional Information
Heather Webber, PhD
The University of Texas Health Science Center at Houston
Phone: 713-486-2723
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place