Trial Outcomes & Findings for Repeated-dose Behavioral Intervention to Reduce Opioid Overdose (NCT NCT03838510)
NCT ID: NCT03838510
Last Updated: 2025-06-15
Results Overview
Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
268 participants
Primary outcome timeframe
16 Months
Results posted on
2025-06-15
Participant Flow
Participant milestones
| Measure |
Brief Counseling Intervention
REBOOT: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.
|
Control Group
The attention control group will watch a show or listen to a podcast for the same time duration as the intervention sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
135
|
|
Overall Study
COMPLETED
|
112
|
121
|
|
Overall Study
NOT COMPLETED
|
21
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repeated-dose Behavioral Intervention to Reduce Opioid Overdose
Baseline characteristics by cohort
| Measure |
Brief Counseling Intervention
n=133 Participants
REBOOT: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.
|
Control Group
n=135 Participants
Participants in the control group will watch a show or listen to a podcast for the same amount of time as an intervention session as an attention control.
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
43 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
86 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
46 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
133 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 MonthsNumber of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
Outcome measures
| Measure |
Brief Counseling Intervention
n=133 Participants
REBOOT: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.
|
Control Group
n=135 Participants
Participants in the control group will watch a show or listen to a podcast for the same amount of time as an intervention session as an attention control.
|
|---|---|---|
|
Number of Overdose Events
|
0 overdoses
Interval 0.0 to 1.0
|
0 overdoses
Interval 0.0 to 1.0
|
Adverse Events
Brief Counseling Intervention
Serious events: 88 serious events
Other events: 69 other events
Deaths: 4 deaths
Control Group
Serious events: 78 serious events
Other events: 60 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Brief Counseling Intervention
n=133 participants at risk
REBOOT: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.
|
Control Group
n=135 participants at risk
Participants in the control group will watch a show or listen to a podcast for the same amount of time as an intervention session as an attention control.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.75%
1/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
fungal infection of blood
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
food poisoning
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
blood poisoning/sepsis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
blood infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
soft tissue infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
knee infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
overdose
|
0.00%
0/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Cardiac disorders
heart failure
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Cardiac disorders
heart attack
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Gastrointestinal disorders
hernia
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Gastrointestinal disorders
norovirus
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Hepatobiliary disorders
gallstone
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Hepatobiliary disorders
gallbladder infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Immune system disorders
adverse reaction to medication
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
endocarditis
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
muscle infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
hand infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
pneumonia
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
UTI
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
abcess
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
excessive sweating/fever
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
car accident
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
head injury
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
broken wrist
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
physical assault
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
dislocated shoulder
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
blood poisoning and kidney failure
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
car accident
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
broken ankle
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
back and shoulder pain
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Nervous system disorders
seizure
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Nervous system disorders
memory loss and headache
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Nervous system disorders
confusion, loss of balance, slurred speech
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Nervous system disorders
coma
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Psychiatric disorders
panic attack
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Psychiatric disorders
psych emergency
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Psychiatric disorders
depressive episode
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Psychiatric disorders
5150 hold
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Renal and urinary disorders
complications related to dialysis
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Renal and urinary disorders
kidney failure
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Renal and urinary disorders
bladder cancer
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
abscess
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
wrist abscess
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
cyst
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
abscess/cellulitis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Cardiac disorders
heart murmur
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Cardiac disorders
endocarditis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Cardiac disorders
overdose
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Endocrine disorders
high blood sugar
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Gastrointestinal disorders
constipation
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Gastrointestinal disorders
GERD
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
General disorders
adverse reaction to medication
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Immune system disorders
sepsis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
strep throat
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
tooth infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
stabbing
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
coma
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
staph infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
brain bruise
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
withdrawal symptoms
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
stimulant overdose
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
death, suspected overdose
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
adverse reaction to medication
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
back and hip pain
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
foot pain and swelling
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
physical assault
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
staph infection, rhabdomyolysis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
spinal fractures
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
hernia
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Nervous system disorders
head injury
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Nervous system disorders
confusion/disorientation
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Nervous system disorders
stroke
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Nervous system disorders
loss of consciousness
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Pregnancy, puerperium and perinatal conditions
high risk pregnancy
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Psychiatric disorders
mental health crisis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Psychiatric disorders
inpatient psych hold
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Renal and urinary disorders
kidney stone
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
low oxygen
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
chest pain
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
staph infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
leg infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
foot infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
thigh abscess
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
neck abscess
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
sepsis/cellulitis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
thumb blister
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
arm infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Surgical and medical procedures
hysterectomy
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
Other adverse events
| Measure |
Brief Counseling Intervention
n=133 participants at risk
REBOOT: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.
|
Control Group
n=135 participants at risk
Participants in the control group will watch a show or listen to a podcast for the same amount of time as an intervention session as an attention control.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
chest pain
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Blood and lymphatic system disorders
leg swelling
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Cardiac disorders
dizziness
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Cardiac disorders
heart murmur
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Gastrointestinal disorders
ulcers
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Gastrointestinal disorders
GI lesions/ulcers
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Gastrointestinal disorders
ulcerative colitis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
General disorders
fatigue
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
Hepatitis C infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
spinal infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
UTI
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
flu
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
toe infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
stomach flu
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
testicle infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Infections and infestations
infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
knee injury
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
back injury
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
shoulder injury
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
head injury
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
broken wrist
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
blood clots
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
broken thumb
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Injury, poisoning and procedural complications
physical assault
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
dislocated shoulder
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Metabolism and nutrition disorders
unintentional weight loss
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
scoliosis worsening
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
painful sciatic nerve
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
arthritis in feet
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
broken finger
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Nervous system disorders
losing control of hand
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Nervous system disorders
pain, loss of sensation on right side of body
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Nervous system disorders
neurological changes s/p stroke
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Nervous system disorders
seizure
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Psychiatric disorders
insomnia
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Psychiatric disorders
ED visit (unspecified)
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
congestion and cough
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
chest discomfort
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
difficulty breathing
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
abscess
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
MRSA infection
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
herpes
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
sublocade injection reaction
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
leg wound
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
psoriasis
|
0.00%
0/133 • 16 months
|
0.74%
1/135 • 16 months
|
|
Gastrointestinal disorders
stomach/bowel issue
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Gastrointestinal disorders
colon pain
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Gastrointestinal disorders
diarrhea
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Gastrointestinal disorders
withdrawal symptoms
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
General disorders
soreness due to dental work
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
General disorders
withdrawal symptoms
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Immune system disorders
allergic reaction
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
COVID-19
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
stomach virus
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
orchitis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
chlamydia
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
HIV
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
bacterial infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Infections and infestations
tooth pain
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
overdose
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
bike accident
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
car accident
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
injury due to physical assault
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
headache due to physical assault
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
sprained ankle
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
burn
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
injury from fall
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
pulled muscle
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
lost teeth due to injury
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
dog bite
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
knife injury
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
broken foot
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Injury, poisoning and procedural complications
hand injury
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Metabolism and nutrition disorders
unintentional weight gain
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
broken cast
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Musculoskeletal and connective tissue disorders
hip pain/arthritis
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Nervous system disorders
nervous twitching
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Psychiatric disorders
anxiety attack
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Reproductive system and breast disorders
painful menstruation
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Reproductive system and breast disorders
cervical polyp
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Reproductive system and breast disorders
HPV infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
lump in neck
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
swollen feet
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
rash/lesions
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
wound due to injection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
leg infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
swollen eye
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
infection
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Skin and subcutaneous tissue disorders
blood infection/abscess
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Social circumstances
needle stick
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
|
Vascular disorders
blood clot
|
0.75%
1/133 • 16 months
|
0.00%
0/135 • 16 months
|
Additional Information
Phillip Coffin, MD, MIA
San Francisco Department of Public Health, University fo California San Francisco
Phone: 628-217-6282
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place