Trial Outcomes & Findings for Cocaine and Zolmitriptan (NCT NCT05019430)
NCT ID: NCT05019430
Last Updated: 2025-08-05
Results Overview
Number of Times Subjects Choose Cocaine (Maximum of 5 Choices) Over Money
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Over approximately four hours on each experimental session day, which generally occurred on Days 5-7, 13-15, 21-23 and 29-31 of inpatient admission.
Results posted on
2025-08-05
Participant Flow
Participant milestones
| Measure |
Overall Study
This study used a within subjects design (i.e., all subjects were to receive all oral zolmitriptan maintenance conditions \[0, 2.5, 5 and 10 mg\] and intravenous cocaine doses \[0, 10 and 30 mg/70 kg\]). Nine subjects completed the full study. Three additional subjects were enrolled but discharged prior to completing the full study. Data from completed sessions for those subjects are included here.
Dose Condition 1: 0 mg zolmitriptan, 0 mg cocaine Dose Condition 2: 0 mg zolmitriptan, 10 mg cocaine Dose Condition 3: 0 mg zolmitriptan, 30 mg cocaine Dose Condition 4: 2.5 mg zolmitriptan, 0 mg cocaine Dose Condition 5: 2.5 mg zolmitriptan, 10 mg cocaine Dose Condition 6: 2.5 mg zolmitriptan, 30 mg cocaine Dose Condition 7: 5 mg zolmitriptan, 0 mg cocaine Dose Condition 8: 5 mg zolmitriptan, 10 mg cocaine Dose Condition 9: 5 mg zolmitriptan, 30 mg cocaine Dose Condition 10: 10 mg zolmitriptan, 0 mg cocaine Dose Condition 11: 10 mg zolmitriptan, 10 mg cocaine Dose Condition 12: 10 mg zolmitriptan, 30 mg cocaine
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
Dose Condition 1
|
9
|
|
Overall Study
Dose Condition 2
|
10
|
|
Overall Study
Dose Condition 3
|
10
|
|
Overall Study
Dose Condition 4
|
10
|
|
Overall Study
Dose Condition 5
|
10
|
|
Overall Study
Dose Condition 6
|
10
|
|
Overall Study
Dose Condition 7
|
11
|
|
Overall Study
Dose Condition 8
|
11
|
|
Overall Study
Dose Condition 9
|
11
|
|
Overall Study
Dose Condition 10
|
11
|
|
Overall Study
Dose Condition 11
|
11
|
|
Overall Study
Dose Condition 12
|
11
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cocaine and Zolmitriptan
Baseline characteristics by cohort
| Measure |
Overall Study
n=12 Participants
This study used a within subjects design (i.e., all subjects were to receive all oral zolmitriptan maintenance conditions \[0, 2.5, 5 and 10 mg\] and intravenous cocaine doses \[0, 10 and 30 mg/70 kg\]). Ten subjects completed the full study. Two additional subjects were enrolled but discharged prior to completing the full study. Data from completed sessions for those subjects are included here.
|
|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Over approximately four hours on each experimental session day, which generally occurred on Days 5-7, 13-15, 21-23 and 29-31 of inpatient admission.Population: Subjects completing the dose condition
Number of Times Subjects Choose Cocaine (Maximum of 5 Choices) Over Money
Outcome measures
| Measure |
Dose Condition 1
n=9 Participants
0 mg/70 kg IV Cocaine and 0 mg/day Oral Zolmitriptan
|
Dose Condition 2
n=10 Participants
10 mg/70 kg IV Cocaine and 0 mg/day Oral Zolmitriptan
|
Dose Condition 3
n=10 Participants
30 mg/70 kg IV Cocaine and 0 mg/day Oral Zolmitriptan
|
Dose Condition 4
n=10 Participants
0 mg/70 kg IV Cocaine and 2.5 mg/day Oral Zolmitriptan
|
Dose Condition 5
n=10 Participants
10 mg/70 kg IV Cocaine and 2.5 mg/day Oral Zolmitriptan
|
Dose Condition 6
n=10 Participants
30 mg/70 kg IV Cocaine and 2.5 mg/day Oral Zolmitriptan
|
Dose Condition 7
n=11 Participants
0 mg/70 kg IV Cocaine and 5 mg/day Oral Zolmitriptan
|
Dose Condition 8
n=11 Participants
10 mg/70 kg IV Cocaine and 5 mg/day Oral Zolmitriptan
|
Dose Condition 9
n=11 Participants
30 mg/70 kg IV Cocaine and 5 mg/day Oral Zolmitriptan
|
Dose Condition 10
n=11 Participants
0 mg/70 kg IV Cocaine and 10 mg/day Oral Zolmitriptan
|
Dose Condition 11
n=11 Participants
10 mg/70 kg IV Cocaine and 10 mg/day Oral Zolmitriptan
|
Dose Condition 12
n=11 Participants
30 mg/70 kg IV Cocaine and 10 mg/day Oral Zolmitriptan
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Reinforcing Effects of Cocaine
|
1.4 number of times subjects chose cocaine
Standard Deviation 1.96
|
4 number of times subjects chose cocaine
Standard Deviation 1.61
|
4.5 number of times subjects chose cocaine
Standard Deviation 1.51
|
0.7 number of times subjects chose cocaine
Standard Deviation 1.57
|
3.6 number of times subjects chose cocaine
Standard Deviation 2.06
|
4.5 number of times subjects chose cocaine
Standard Deviation 1.58
|
0.6 number of times subjects chose cocaine
Standard Deviation 1.57
|
3.5 number of times subjects chose cocaine
Standard Deviation 1.97
|
4.6 number of times subjects chose cocaine
Standard Deviation 0.67
|
0.7 number of times subjects chose cocaine
Standard Deviation 1.42
|
4.1 number of times subjects chose cocaine
Standard Deviation 1.45
|
4.2 number of times subjects chose cocaine
Standard Deviation 1.83
|
Adverse Events
Zolmitriptan (0 mg/Day)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Zolmitriptan (2.5 mg/Day)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Zolmitriptan (5 mg/Day)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Zolmitriptan (10 mg/Day)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zolmitriptan (0 mg/Day)
n=10 participants at risk
Maintenance on 0 mg Zolmitriptan/day
|
Zolmitriptan (2.5 mg/Day)
n=10 participants at risk
Maintenance on 2.5 mg Zolmitriptan/day
|
Zolmitriptan (5 mg/Day)
n=11 participants at risk
Maintenance on 5 mg Zolmitriptan/day
|
Zolmitriptan (10 mg/Day)
n=11 participants at risk
Maintenance on 5 mg Zolmitriptan/day
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood clot
|
10.0%
1/10 • Number of events 1 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
Other adverse events
| Measure |
Zolmitriptan (0 mg/Day)
n=10 participants at risk
Maintenance on 0 mg Zolmitriptan/day
|
Zolmitriptan (2.5 mg/Day)
n=10 participants at risk
Maintenance on 2.5 mg Zolmitriptan/day
|
Zolmitriptan (5 mg/Day)
n=11 participants at risk
Maintenance on 5 mg Zolmitriptan/day
|
Zolmitriptan (10 mg/Day)
n=11 participants at risk
Maintenance on 5 mg Zolmitriptan/day
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
50.0%
5/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
40.0%
4/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
27.3%
3/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
45.5%
5/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Cardiac disorders
Hypertension
|
40.0%
4/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
40.0%
4/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
54.5%
6/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
63.6%
7/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Surgical and medical procedures
Deviated Midline Catheter
|
20.0%
2/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Cardiac disorders
ST Elevation More Peaked
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Gastrointestinal disorders
Tasting Saline
|
30.0%
3/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Gastrointestinal disorders
Heartburn
|
20.0%
2/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Immune system disorders
Fever
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Fluid Leak (from Midline)
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
20.0%
2/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Pain at Midline Site
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
30.0%
3/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Redness
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation from Adhesive
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Itching at Midline Site
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
30.0%
3/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
27.3%
3/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
27.3%
3/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Nervous system disorders
Sleepiness
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Nervous system disorders
Sinus Headache
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Nervous system disorders
Insomnia
|
20.0%
2/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
18.2%
2/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Nervous system disorders
Vivid dreams
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Musculoskeletal and connective tissue disorders
Diffuse body pain
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Musculoskeletal and connective tissue disorders
foot pain
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
2/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
10.0%
1/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/10 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
0.00%
0/11 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
9.1%
1/11 • Number of events 1 • Approximately 1 month of inpatient admission.
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place