Trial Outcomes & Findings for The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence (NCT NCT01556425)
NCT ID: NCT01556425
Last Updated: 2018-03-12
Results Overview
Was the participant's urine sample negative for opiates at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for opiates.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-03-12
Participant Flow
Participant milestones
| Measure |
Vivitrol Only
The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.
Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.
|
VIVITROL&Opiate Abstinence Reinforcement
This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Opiate Abstinence Reinforcement Only
This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.
Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Usual Care Control
This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.
Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
18
|
18
|
|
Overall Study
COMPLETED
|
25
|
23
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence
Baseline characteristics by cohort
| Measure |
Vivitrol Only
n=25 Participants
The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.
Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.
|
VIVITROL&Opiate Abstinence Reinforcement
n=23 Participants
This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Opiate Abstinence Reinforcement Only
n=18 Participants
This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.
Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Usual Care Control
n=18 Participants
This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.
Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 10.3 • n=93 Participants
|
43.1 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
41.1 years
STANDARD_DEVIATION 11.1 • n=27 Participants
|
42.2 years
STANDARD_DEVIATION 11.4 • n=483 Participants
|
42.7 years
STANDARD_DEVIATION 10.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
60 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
68 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
84 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 24 weeksWas the participant's urine sample negative for opiates at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for opiates.
Outcome measures
| Measure |
Vivitrol Only
n=25 Participants
The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.
Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.
|
VIVITROL&Opiate Abstinence Reinforcement
n=23 Participants
This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Opiate Abstinence Reinforcement Only
n=18 Participants
This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.
Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Usual Care Control
n=18 Participants
This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.
Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.
|
|---|---|---|---|---|
|
Percent of Weekly Urine Samples Negative for Opiates
|
64.5 percentage of negative urine samples
Interval 0.0 to 100.0
|
81.3 percentage of negative urine samples
Interval 0.0 to 100.0
|
71.1 percentage of negative urine samples
Interval 0.0 to 100.0
|
66.7 percentage of negative urine samples
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 24 weeksWas the participant's urine sample negative for cocaine at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for cocaine.
Outcome measures
| Measure |
Vivitrol Only
n=25 Participants
The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.
Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.
|
VIVITROL&Opiate Abstinence Reinforcement
n=23 Participants
This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Opiate Abstinence Reinforcement Only
n=18 Participants
This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.
Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Usual Care Control
n=18 Participants
This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.
Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.
|
|---|---|---|---|---|
|
Percent of Weekly Urine Samples Negative for Cocaine
|
60.8 percentage of cocaine negative samples
Interval 0.0 to 100.0
|
68.1 percentage of cocaine negative samples
Interval 0.0 to 100.0
|
56.3 percentage of cocaine negative samples
Interval 0.0 to 100.0
|
68.3 percentage of cocaine negative samples
Interval 0.0 to 100.0
|
Adverse Events
Vivitrol Only
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
VIVITROL&Opiate Abstinence Reinforcement
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Opiate Abstinence Reinforcement Only
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Usual Care Control
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vivitrol Only
n=25 participants at risk
The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.
Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.
|
VIVITROL&Opiate Abstinence Reinforcement
n=23 participants at risk
This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Opiate Abstinence Reinforcement Only
n=18 participants at risk
This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.
Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Usual Care Control
n=18 participants at risk
This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.
Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.
|
|---|---|---|---|---|
|
Nervous system disorders
death
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
0.00%
0/18 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Cardiac disorders
Chest pain
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
0.00%
0/18 • 1 year
|
|
Blood and lymphatic system disorders
Diabetes
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Nervous system disorders
Viral menningitis
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Nervous system disorders
Seizure
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
0.00%
0/18 • 1 year
|
|
Psychiatric disorders
alcohol detoxification
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Psychiatric disorders
Psychiatric treatment
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Nervous system disorders
Stroke
|
0.00%
0/25 • 1 year
|
4.3%
1/23 • Number of events 1 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Nervous system disorders
Weakness on right side of body
|
0.00%
0/25 • 1 year
|
4.3%
1/23 • Number of events 1 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
Other adverse events
| Measure |
Vivitrol Only
n=25 participants at risk
The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.
Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.
|
VIVITROL&Opiate Abstinence Reinforcement
n=23 participants at risk
This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Opiate Abstinence Reinforcement Only
n=18 participants at risk
This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.
Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
|
Usual Care Control
n=18 participants at risk
This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.
Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Abnormal liver function test
|
8.0%
2/25 • Number of events 2 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
elbow injury
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
General disorders
Assault
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/25 • 1 year
|
4.3%
1/23 • Number of events 1 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Broken ribs
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Psychiatric disorders
hallucinations
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
infection
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
8.0%
2/25 • Number of events 2 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back injury
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
leg injury
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
arm injury
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
11.1%
2/18 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Psychiatric treatment
|
0.00%
0/25 • 1 year
|
4.3%
1/23 • Number of events 1 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Liver discomfort
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
0.00%
0/25 • 1 year
|
4.3%
1/23 • Number of events 1 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/18 • 1 year
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/25 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/18 • 1 year
|
5.6%
1/18 • Number of events 1 • 1 year
|
Additional Information
Kenneth Silverman
Johns Hopkins University School of Medicine
Phone: 410-550-2694
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place