Trial Outcomes & Findings for Oxytocin, Stress, Craving, Opioid Use Disorder (NCT NCT04051619)
NCT ID: NCT04051619
Last Updated: 2025-05-25
Results Overview
The primary outcome will test the effect of oxytocin, compared to placebo, on opioid craving during two laboratory stress induction, paired to a cue reactivity paradigm. The dependent measure for the primary aim is the Desire for Drug Questionnaire (DDQ). The stress induction will be done using yohimbine or matching placebo (counterbalanced) during the two laboratory sessions. At each visit the DDQ will be administered 3 times: before starting any procedure, after the yohimbine challenge, and after the cue-reactivity. This outcome will be compared between oxytocin and matching-placebo. Minimum score=0 no craving at all, maximum score= 91 severe craving (13 questions on a 7-step Likert-scale)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Before starting any procedure, after the yohimbine challenge, and after the cue-reactivity at each laboratory session, which occurred between days 5-7 and days 14-16.
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Oxytocin First, Then Placebo
Oxytocin was administered as 40 IU/0.12 mL nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
Matching Placebo First, Then Oxytocin
Placebo was administered as nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
|---|---|---|
|
1st Allocation, 7 Days
STARTED
|
10
|
10
|
|
1st Allocation, 7 Days
Received Yohimbine and Matched Placebo During Lab Sessions 3 and 4.
|
8
|
8
|
|
1st Allocation, 7 Days
COMPLETED
|
10
|
10
|
|
1st Allocation, 7 Days
NOT COMPLETED
|
0
|
0
|
|
2nd Allocation (Cross Over)
STARTED
|
10
|
10
|
|
2nd Allocation (Cross Over)
Received Yohimbine and Matched Placebo During Lab Sessions 5 and 6.
|
5
|
5
|
|
2nd Allocation (Cross Over)
COMPLETED
|
7
|
6
|
|
2nd Allocation (Cross Over)
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Oxytocin First, Then Placebo
Oxytocin was administered as 40 IU/0.12 mL nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
Matching Placebo First, Then Oxytocin
Placebo was administered as nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
|---|---|---|
|
2nd Allocation (Cross Over)
Lost to Follow-up
|
1
|
2
|
|
2nd Allocation (Cross Over)
Completed the study prior to initiation cross-over design
|
2
|
2
|
Baseline Characteristics
Oxytocin, Stress, Craving, Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
Outcome measures are grouped into a single arm: all study participants. This is because the crossover design led participants to receive both oxytocin and the matched placebo during the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or multiracial
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
|
Clinical Opiate Withdrawal Scale (COWS)
|
.9 score on an 11-item scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Before starting any procedure, after the yohimbine challenge, and after the cue-reactivity at each laboratory session, which occurred between days 5-7 and days 14-16.The primary outcome will test the effect of oxytocin, compared to placebo, on opioid craving during two laboratory stress induction, paired to a cue reactivity paradigm. The dependent measure for the primary aim is the Desire for Drug Questionnaire (DDQ). The stress induction will be done using yohimbine or matching placebo (counterbalanced) during the two laboratory sessions. At each visit the DDQ will be administered 3 times: before starting any procedure, after the yohimbine challenge, and after the cue-reactivity. This outcome will be compared between oxytocin and matching-placebo. Minimum score=0 no craving at all, maximum score= 91 severe craving (13 questions on a 7-step Likert-scale)
Outcome measures
| Measure |
Oxytocin
n=16 Participants
Oxytocin was administered as 40 IU/0.12 mL nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
Matching Placebo
n=17 Participants
Placebo was administered as nasal spray in each nostril once in the morning and once in the afternoon for 7 days.
|
|---|---|---|
|
Opioid Craving
baseline (yohimbine condition)
|
21.6 score on a scale
Standard Deviation 7.55
|
22.4 score on a scale
Standard Deviation 6.26
|
|
Opioid Craving
after stress (yohimbine condition)
|
23.3 score on a scale
Standard Deviation 7.66
|
23.4 score on a scale
Standard Deviation 7.53
|
|
Opioid Craving
cue exposure (yohimbine condition)
|
22.9 score on a scale
Standard Deviation 8.09
|
23.0 score on a scale
Standard Deviation 7.92
|
|
Opioid Craving
baseline (yohimbine-placebo condition)
|
22.7 score on a scale
Standard Deviation 7.85
|
19.5 score on a scale
Standard Deviation 6.16
|
|
Opioid Craving
after stress (yohimbine-placebo condition)
|
23.1 score on a scale
Standard Deviation 6.95
|
21.7 score on a scale
Standard Deviation 7.18
|
|
Opioid Craving
cue exposure (yohimbine-placebo condition)
|
22.6 score on a scale
Standard Deviation 6.74
|
20.9 score on a scale
Standard Deviation 7.88
|
SECONDARY outcome
Timeframe: Before starting any procedure, after the yohimbine challenge, and after the cue-reactivity at each laboratory session, which occurred between days 5-7 and days 14-16.Participants will complete a laboratory session that includes a battery of medical/physiological/psychological assessments to monitor adverse events. Safety measures include: opiate withdrawal syndrome by Clinical Opiate Withdrawal Scale (COWS) pre and post the laboratory procedures. The COWS is an 11-item scale designed to be administered by a clinician. Minimum=0 (no withdrawal); Maximum=36 (sever withdrawal). The stress induction will be done using yohimbine or matching placebo (counterbalanced) during the two laboratory sessions. High score worse outcome. At each visit the COWS will be administered 2 times: before starting any procedure, and after the cue-reactivity. This outcome will be compared between oxytocin and matching-placebo.
Outcome measures
| Measure |
Oxytocin
n=16 Participants
Oxytocin was administered as 40 IU/0.12 mL nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
Matching Placebo
n=17 Participants
Placebo was administered as nasal spray in each nostril once in the morning and once in the afternoon for 7 days.
|
|---|---|---|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Opiate Withdrawal Syndrome
Baseline (Yohimbine Condition)
|
1.2 score on a scale
Standard Deviation 1.17
|
0.8 score on a scale
Standard Deviation .75
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Opiate Withdrawal Syndrome
Post (Yohimbine Condition)
|
1.8 score on a scale
Standard Deviation 2.23
|
3.0 score on a scale
Standard Deviation 3.30
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Opiate Withdrawal Syndrome
Baseline (Yohimbine-placebo Condition)
|
1.0 score on a scale
Standard Deviation 1.45
|
1.3 score on a scale
Standard Deviation 1.38
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Opiate Withdrawal Syndrome
Post (Yohimbine-placebo Condition)
|
0.7 score on a scale
Standard Deviation 0.84
|
0.6 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Before starting any procedure, after the yohimbine challenge, and after the cue-reactivity at each laboratory session, which occurred between days 5-7 and days 14-16.Participants will complete a laboratory session that includes a battery of medical/physiological/psychological assessments to monitor adverse events. Safety measures include: monitor anxiety (HAMA) during lab sessions. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of Minimum=0 (not present), Maximum=56 (sever), where \<17 mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. The stress induction will be done using yohimbine or matching placebo (counterbalanced) during the two laboratory sessions. High score worse outcome. At each visit the HAMA will be administered 3 times: before starting any procedure, after the yohimbine challenge, and after the cue-reactivity. This outcome will be compared between oxytocin and matching-placebo.
Outcome measures
| Measure |
Oxytocin
n=16 Participants
Oxytocin was administered as 40 IU/0.12 mL nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
Matching Placebo
n=17 Participants
Placebo was administered as nasal spray in each nostril once in the morning and once in the afternoon for 7 days.
|
|---|---|---|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Anxiety
Baseline (Yohimbine condition)
|
1.8 score on a scale
Standard Deviation 2.10
|
2.5 score on a scale
Standard Deviation 2.39
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Anxiety
after stress (Yohimbine condition)
|
2.0 score on a scale
Standard Deviation 2.98
|
2.7 score on a scale
Standard Deviation 3.65
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Anxiety
after cue exposure (Yohimbine condition)
|
1.9 score on a scale
Standard Deviation 1.85
|
2.7 score on a scale
Standard Deviation 2.53
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Anxiety
Baseline (Yohimbine-placebo condition)
|
1.3 score on a scale
Standard Deviation 1.69
|
2.2 score on a scale
Standard Deviation 2.35
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Anxiety
after stress (Yohimbine-placebo condition)
|
0.9 score on a scale
Standard Deviation 1.3
|
1.2 score on a scale
Standard Deviation 1.50
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Anxiety
after cue exposure (Yohimbine-placebo condition)
|
0.9 score on a scale
Standard Deviation 1.7
|
1.0 score on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Before starting any procedure, after the yohimbine challenge, and after the cue-reactivity at each laboratory session, which occurred between days 5-7 and days 14-16.Participants will complete a laboratory session that includes a battery of medical/physiological/psychological assessments to monitor adverse events. Safety measures include: monitor systolic blood pressure (SBP) during lab sessions. The stress induction will be done using yohimbine or matching placebo (counterbalanced) during the two laboratory sessions. At each visit the SBP will be administered 3 times: before starting any procedure, after the yohimbine challenge, and after the cue-reactivity. This outcome will be compared between oxytocin and matching-placebo.
Outcome measures
| Measure |
Oxytocin
n=16 Participants
Oxytocin was administered as 40 IU/0.12 mL nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
Matching Placebo
n=17 Participants
Placebo was administered as nasal spray in each nostril once in the morning and once in the afternoon for 7 days.
|
|---|---|---|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Systolic Blood Pressure (SBP)
baseline (yohimbine condition)
|
127.9 mmHg
Standard Deviation 19.97
|
124.2 mmHg
Standard Deviation 19.80
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Systolic Blood Pressure (SBP)
after stress (yohimbine condition)
|
134.2 mmHg
Standard Deviation 21.90
|
137.2 mmHg
Standard Deviation 18.30
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Systolic Blood Pressure (SBP)
after cue exposure (yohimbine condition)
|
133.4 mmHg
Standard Deviation 28.80
|
147.2 mmHg
Standard Deviation 25.40
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Systolic Blood Pressure (SBP)
baseline (yohimbine-placebo condition)
|
129.2 mmHg
Standard Deviation 16.30
|
126.9 mmHg
Standard Deviation 20.50
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Systolic Blood Pressure (SBP)
after stress (yohimbine-placebo condition)
|
120.8 mmHg
Standard Deviation 10.90
|
121.3 mmHg
Standard Deviation 16.60
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Systolic Blood Pressure (SBP)
after cue exposure (yohimbine-placebo condition)
|
123.9 mmHg
Standard Deviation 16.50
|
123.0 mmHg
Standard Deviation 13.40
|
SECONDARY outcome
Timeframe: Before starting any procedure, after the yohimbine challenge, and after the cue-reactivity at each laboratory session, which occurred between days 5-7 and days 14-16.Participants will complete a laboratory session that includes a battery of medical/physiological/psychological assessments to monitor adverse events. Safety measures include: monitor Heart rate (HR) during lab sessions. The stress induction will be done using yohimbine or matching placebo (counterbalanced) during the two laboratory sessions. At each visit the HR will be administered 3 times: before starting any procedure, after the yohimbine challenge, and after the cue-reactivity. This outcome will be compared between oxytocin and matching-placebo.
Outcome measures
| Measure |
Oxytocin
n=16 Participants
Oxytocin was administered as 40 IU/0.12 mL nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
Matching Placebo
n=17 Participants
Placebo was administered as nasal spray in each nostril once in the morning and once in the afternoon for 7 days.
|
|---|---|---|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Heart Rate (HR)
after stress (yohimbine condition)
|
75.5 beat/min
Standard Deviation 14.6
|
83.1 beat/min
Standard Deviation 11.2
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Heart Rate (HR)
after cue exposure (yohimbine condition)
|
74.6 beat/min
Standard Deviation 18.2
|
77.5 beat/min
Standard Deviation 13.1
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Heart Rate (HR)
baseline (yohimbine-placebo condition)
|
77.9 beat/min
Standard Deviation 16.1
|
80.0 beat/min
Standard Deviation 13.1
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Heart Rate (HR)
baseline (yohimbine condition)
|
83.0 beat/min
Standard Deviation 16.7
|
80.0 beat/min
Standard Deviation 13.9
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Heart Rate (HR)
after stress (yohimbine-placebo condition)
|
69.4 beat/min
Standard Deviation 14.7
|
81.0 beat/min
Standard Deviation 12.9
|
|
Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Heart Rate (HR)
after cue exposure (yohimbine-placebo condition)
|
66.3 beat/min
Standard Deviation 12.4
|
82.0 beat/min
Standard Deviation 17.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before starting any procedure, after the yohimbine challenge, and after the cue-reactivity at each laboratory session, which occurred between days 5-7 and days 14-16.Cortisol (biomarker for stress level) will be measured at the same 3 time points as other measures. The stress induction will be done using yohimbine or matching placebo (counterbalanced) during the two laboratory sessions. At each visit the cortisol will be administered 3 times: before starting any procedure, after the yohimbine challenge, and after the cue-reactivity. This outcome will be compared between oxytocin and matching-placebo.
Outcome measures
| Measure |
Oxytocin
n=16 Participants
Oxytocin was administered as 40 IU/0.12 mL nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
Matching Placebo
n=17 Participants
Placebo was administered as nasal spray in each nostril once in the morning and once in the afternoon for 7 days.
|
|---|---|---|
|
Stress-related Response in OUD Individuals Receiving Opioid Agonist Therapy: Salivary Cortisol
baseline (yohimbine-placebo condition)
|
0.28 ug/dL
Standard Deviation 0.21
|
0.31 ug/dL
Standard Deviation 0.31
|
|
Stress-related Response in OUD Individuals Receiving Opioid Agonist Therapy: Salivary Cortisol
baseline (yohimbine condition)
|
0.33 ug/dL
Standard Deviation 0.15
|
0.24 ug/dL
Standard Deviation 0.14
|
|
Stress-related Response in OUD Individuals Receiving Opioid Agonist Therapy: Salivary Cortisol
after stress (yohimbine condition)
|
0.29 ug/dL
Standard Deviation 0.11
|
0.27 ug/dL
Standard Deviation 0.16
|
|
Stress-related Response in OUD Individuals Receiving Opioid Agonist Therapy: Salivary Cortisol
after cue exposure (yohimbine condition)
|
0.32 ug/dL
Standard Deviation 0.25
|
0.80 ug/dL
Standard Deviation 0.70
|
|
Stress-related Response in OUD Individuals Receiving Opioid Agonist Therapy: Salivary Cortisol
after stress (yohimbine-placebo condition)
|
0.23 ug/dL
Standard Deviation 0.13
|
0.24 ug/dL
Standard Deviation 0.21
|
|
Stress-related Response in OUD Individuals Receiving Opioid Agonist Therapy: Salivary Cortisol
after cue exposure (yohimbine-placebo condition)
|
0.20 ug/dL
Standard Deviation 0.11
|
0.17 ug/dL
Standard Deviation 0.13
|
Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin
n=16 participants at risk
Oxytocin was administered as 40 IU/0.12 mL nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
Matching Placebo
n=17 participants at risk
Placebo was administered as nasal spray in each nostril once in the morning and once in the afternoon for 7 days: Adjunct therapy
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 2 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
17.6%
3/17 • Number of events 4 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Gastrointestinal disorders
Decrease in appetite
|
18.8%
3/16 • Number of events 5 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
17.6%
3/17 • Number of events 3 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Nervous system disorders
Difficulty sleeping
|
31.2%
5/16 • Number of events 6 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
35.3%
6/17 • Number of events 6 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Nervous system disorders
Slowness, sleepiness, or fatigue
|
18.8%
3/16 • Number of events 5 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
23.5%
4/17 • Number of events 6 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Nervous system disorders
Difficulty with concentration or attention
|
37.5%
6/16 • Number of events 7 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
17.6%
3/17 • Number of events 4 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Musculoskeletal and connective tissue disorders
Tingling in fingers or toes
|
12.5%
2/16 • Number of events 2 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
23.5%
4/17 • Number of events 4 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
6.2%
1/16 • Number of events 1 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
23.5%
4/17 • Number of events 4 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 2 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
17.6%
3/17 • Number of events 5 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 5 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
35.3%
6/17 • Number of events 6 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Psychiatric disorders
Nervousness or anxiety
|
43.8%
7/16 • Number of events 12 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
47.1%
8/17 • Number of events 14 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Nervous system disorders
Irritability
|
25.0%
4/16 • Number of events 4 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
17.6%
3/17 • Number of events 3 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Psychiatric disorders
Depression or other mood disturbance
|
50.0%
8/16 • Number of events 9 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
47.1%
8/17 • Number of events 8 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
6.2%
1/16 • Number of events 1 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
29.4%
5/17 • Number of events 5 • Safety and tolerability were measured retrospectively during the one-week outpatient setting
We did not enroll any participant who was at risk of mortality, suicide or serious adverse event
|
Additional Information
Carolina Haass-Koffler, PharmD, PhD (PI)
Brown University
Phone: 4155191385
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place