OAPXRNTX: Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02617628
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 146
• Location: 1
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

This study is a collaboration between the University of Pennsylvania, the Philadelphia Prison System, and the North East Treatment Center (NETSteps). It purpose is to study the impact of an injectable opiate addiction medication (extended release naltrexone) given before reentry into the community that might help to improve reconnection to healthcare and other support systems, and possibly help reduce recidivism.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence	Drug: extended release naltrexone	Phase 2/Phase 3

Detailed Description

The primary objectives for this study is to offer tools to support improve healthcare and related outcomes and reduce the risk of relapse and recidivism for opiate addicted prisoners reentering into the community after release from correctional facilities. In this study the investigators examine a medication-assisted therapy (extended release naltrexone) that is likely to be acceptable to correctional facilities and opioid addicted prisoners and that can improve the outcomes achieved by the usual detoxification/treatment referral approach. The results may be used to facilitate policy changes that involve adding extended release naltrexone to correctional facility formularies for use before reentry, and collaborating with one or more outpatient treatment providers to maintain continuity of care. Two hundred (200) opioid addicted prisoners currently incarcerated in the Philadelphia Prison System, who meet study admission criteria and express an interest in extended release naltrexone treatment, who give informed consent and will be scheduled for release within 14 days of being randomized into the study will be enrolled. These 200 subjects will be stratified by sex (male/females), will be 18 years or older, and are not sentenced).

Study Design

• Study Type: Interventional
• Actual Enrollment: 146 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (Vivitrol) Before vs. After Reentry
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Before Re-entry Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months	Drug: extended release naltrexone; Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison, or either 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.; Other Names: Vivitrol
Active Comparator: After Re-entry Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months	Drug: extended release naltrexone; Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison, or either 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.; Other Names: Vivitrol

Outcome Measures

Primary Outcome Measures

1. Relapse to Opioid Use in Subjects by Month 3 [12 weeks (month 3)]

   Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.

Secondary Outcome Measures

1. Reincarceration [0 to 28 months]

   percentage of patients who were reincarcerated

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Opioid dependent with physiological features according to Diagnostic and Statistical Manual of Mental Disorders-5th edition

• Interested in extended release naltrexone treatment

• Eligible to have health benefits reinstated

• Detoxified and able to pass a naloxone challenge (e.g. no withdrawal within 30 minutes after receiving 0.8 mg naloxone I.M. and documented by a score <5 on the Clinical Opiate Withdrawal Scale

• Age 18 or above

• Not being transferred to serve a longer sentence in a State or Federal prison

• Provide their address or phone number along with the names and contact information of 3 or more persons likely to know where they can be reached with permission to contact them if unable to be reached in other ways

• Able to speak and read English and provide informed consent

• able to correctly answer 9 of 10 study quiz items

• not pregnant and agree to the use of an acceptable form of birth control

• can access to NET Steps via car or public or other transportation after reentry

Exclusion Criteria:

• Planning to move from the Philadelphia area within the next 6 months

• Neurological, cardiovascular, renal, hepatic (Alanine aminotransferase, Aspartate aminotransferase or Gamma-glutamyl transpeptidase >3 times top limit of normal) or another medical disorder that seriously impairs or makes hazardous ability to participate

• Active tuberculosis

• Currently psychotic, homicidal, suicidal

• Uncontrolled seizure disorder

• History of allergy to naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or any other components of the diluent

• Chronic pain for which opioids are needed

• Sentenced to naltrexone Treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center on the Studies of Addiction	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: George E Woody, MD, University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 17, 2019
• Informed Consent Form - May 17, 2019

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02617628
• Other Study ID Numbers: FC14-1409-21688
• First Posted: Dec 1, 2015
• Last Update Posted: Jan 28, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by University of Pennsylvania: opioid addiction
• Additional relevant MeSH terms: Opioid-Related Disorders; Naltrexone

Study Results

Participant Flow

Recruitment Details	Recruitment started August 2016 and ended June 16, 2018 in the Philadelphia Prison System. Subjects all were recruited while incarcerated.
Pre-assignment Detail	Subjects were stratified to sentenced/not sentenced and male/female

Arm/Group Title	Before Re-entry	After Re-entry
Arm/Group Description	Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.	Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
Period Title: Overall Study
STARTED	74	72
COMPLETED	12	11
NOT COMPLETED	62	61

Baseline Characteristics

Arm/Group Title	After Re-entry	Before Re-entry	Total
Arm/Group Description	Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months Extended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone after they were released from prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.	Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months Extended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they left the prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.	Total of all reporting groups
Overall Participants	74	72	146
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	74 100%	72 100%	146 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.7 (10.0)	36.2 (8.5)	37.0 (9.3)
Sex: Female, Male (Count of Participants)
Female	20 27%	20 27.8%	40 27.4%
Male	54 73%	52 72.2%	106 72.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	19 25.7%	18 25%	37 25.3%
Not Hispanic or Latino	55 74.3%	54 75%	109 74.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.4%	0 0%	1 0.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	19 25.7%	10 13.9%	29 19.9%
White	54 73%	61 84.7%	115 78.8%
More than one race	0 0%	1 1.4%	1 0.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	74 100%	72 100%	146 100%
Opioid Drug Use (Count of Participants)
Count of Participants [Participants]	74 100%	72 100%	146 100%
EuroQol Overall Health (Count of Participants)
No Problems	69 93.2%	60 83.3%	129 88.4%
Slight Problems	3 4.1%	4 5.6%	7 4.8%
Moderate Problems	1 1.4%	7 9.7%	8 5.5%
Severe Problems	1 1.4%	0 0%	1 0.7%
x=Missing	0 0%	1 1.4%	1 0.7%
No Problems	71 95.9%	67 93.1%	138 94.5%
Slight Problems	2 2.7%	2 2.8%	4 2.7%
Moderate Problems	1 1.4%	2 2.8%	3 2.1%
Severe Problems	0 0%	0 0%	0 0%
x=Missing	0 0%	1 1.4%	1 0.7%
No Problems	65 87.8%	59 81.9%	124 84.9%
Slight Problems	5 6.8%	8 11.1%	13 8.9%
Moderate Problems	4 5.4%	3 4.2%	7 4.8%
Severe Problems	0 0%	1 1.4%	1 0.7%
x=Missing	0 0%	1 1.4%	1 0.7%
No Problems	42 56.8%	35 48.6%	77 52.7%
Slight Problems	15 20.3%	20 27.8%	35 24%
Moderate Problems	13 17.6%	12 16.7%	25 17.1%
Severe Problems	4 5.4%	4 5.6%	8 5.5%
x=Missing	0 0%	1 1.4%	1 0.7%
No Problems	18 24.3%	21 29.2%	39 26.7%
Slight Problems	27 36.5%	22 30.6%	49 33.6%
Moderate Problems	15 20.3%	21 29.2%	36 24.7%
Severe Problems	14 18.9%	7 9.7%	21 14.4%
x=Missing	0 0%	1 1.4%	1 0.7%
Beck Depression Index (Count of Participants)
No Depression	44 59.5%	39 54.2%	83 56.8%
Clinical Depression	30 40.5%	31 43.1%	61 41.8%
Missing	0 0%	2 2.8%	2 1.4%
Timeline Follow-Back (days) [Mean (Standard Deviation) ]
Heroin Use	21.91 (12.6)	25.56 (9.59)	23.71 (11.3)
Methadone Use	.92 (4.7)	1.19 (4.9)	1.05 (4.7)
Other Opioids	8.46 (12.05)	6.97 (11.06)	7.73 (11.56)
Benzodiazepines	6.36 (10.59)	7.78 (11.11)	7.06 (10.84)
Cocaine	12.7 (13.01)	14.19 (13.27)	13.44 (13.11)
Risk Assessment Battery (units on a scale) [Mean (Standard Deviation) ]
Drug Risk Score	3.19 (4.33)	4.42 (4.87)	3.79 (4.6)
Sex Risk Scoe	5.61 (2.89)	5.94 (2.66)	5.77 (2.77)
Total RAB Score	8.80 (6.17)	10.36 (6.68)	9.57 (6.45)

Outcome Measures

1. Primary Outcome

Title	Relapse to Opioid Use in Subjects by Month 3
Description	Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.
Time Frame	12 weeks (month 3)

Outcome Measure Data

Analysis Population Description

In treatment arm 1 (before reentry) 38 subjects received vivitrol before leaving prison. In treatment arm 2 (after reentry) 48 subjects were eligible to receive injections after release from prison. Arm 2 subjects were to return to the research clinic within 7 days after release to receive their first injection.

Arm/Group Title	Before Re-entry	After Re-entry
Arm/Group Description	Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months. intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.	Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), After they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months. outpatient treatment for six months. Subjects also received weekly psychosocial counseling.
Measure Participants	38	48
Count of Participants [Participants]	16 21.6%	20 27.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Before Re-entry, After Re-entry
	Comments	Based on Lee et al. we estimated a 23-33% group difference in relapse by month 3. Power estimates calculated this estimate with a 2-sided alpha of .05 and a baseline sample size of 100 per group resulted in 80% power to detect a difference of approximately 20% (OR = 2.4) between groups assuming a rate of 50% in the control condition and 10% and 20% attrition by 3- and 6-month follow-ups. For the 86 participants randomized and released, with 80% power; and odds ratio of 3.5.
	Type of Statistical Test	Equivalence
	Comments	The odds ratio for relapse versus non-relapse for the AR group relative to the BR group was analyzed, as well as the corresponding odds ratio for unknown relative to non-relapse.
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.56
	Confidence Interval	(2-Sided) 95%; 0.57 to 4.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	Threshold for significance was set at p<.05

2. Secondary Outcome

Title	Reincarceration
Description	percentage of patients who were reincarcerated
Time Frame	0 to 28 months

Outcome Measure Data

Analysis Population Description

This outcome was determined as follows: one XR-NTX injection provided 4 weeks of treatment. Study patients also had counseling, thus weeks in treatment equaled the weeks of protected time from XR-NTX plus the number of weeks a patient had one or more counseling appointments after the protection from the last XR-NTX dose ended.

Arm/Group Title	Before Re-entry	After Re-entry
Arm/Group Description	Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.	Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
Measure Participants	38	48
Count of Participants [Participants]	28 37.8%	22 30.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Before Re-entry, After Re-entry
	Comments	We used Cox proportional hazards regression model to compare the groups on time to reincarceration.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	-0.74486
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	2 years, 2 months
Adverse Event Reporting Description	The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
Arm/Group Title	Before Re-entry		After Re-entry
Arm/Group Description	Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.		Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.
All Cause Mortality
	Before Re-entry		After Re-entry
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/74 (1.4%)		3/72 (4.2%)
Serious Adverse Events
	Before Re-entry		After Re-entry
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/74 (13.5%)		13/72 (18.1%)
Gastrointestinal disorders
abdominal pain	1/74 (1.4%)	1	0/72 (0%)	0
Musculoskeletal and connective tissue disorders
broken rib	0/74 (0%)	0	1/72 (1.4%)	1
Pregnancy, puerperium and perinatal conditions
pregnancy	0/74 (0%)	0	1/72 (1.4%)	1
Psychiatric disorders
panic attack	0/74 (0%)	0	1/72 (1.4%)	1
suicidal ideation	0/74 (0%)	0	1/72 (1.4%)	1
Renal and urinary disorders
kidney pain	2/74 (2.7%)	2	0/72 (0%)	0
Respiratory, thoracic and mediastinal disorders
overdose	7/74 (9.5%)	7	9/72 (12.5%)	9
Other (Not Including Serious) Adverse Events
	Before Re-entry		After Re-entry
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/74 (47.3%)		21/72 (29.2%)
Cardiac disorders
chest pain-cardiac	1/74 (1.4%)	1	1/72 (1.4%)	1
Eye disorders
blurry vision	1/74 (1.4%)	1	0/72 (0%)	0
allergy in left eye	0/74 (0%)	0	1/72 (1.4%)	1
Gastrointestinal disorders
abdominal pain	1/74 (1.4%)	1	0/72 (0%)	0
diarrhea	3/74 (4.1%)	3	1/72 (1.4%)	1
toothache	6/74 (8.1%)	8	1/72 (1.4%)	1
nausea	3/74 (4.1%)	3	1/72 (1.4%)	1
nausea with vomiting	2/74 (2.7%)	2	0/72 (0%)	0
dry mouth	1/74 (1.4%)	1	2/72 (2.8%)	2
heart burn	1/74 (1.4%)	1	0/72 (0%)	0
sore throat	1/74 (1.4%)	1	0/72 (0%)	0
General disorders
nose bleed	0/74 (0%)	0	1/72 (1.4%)	1
injection site reaction	8/74 (10.8%)	12	4/72 (5.6%)	5
excessive sweating	1/74 (1.4%)	1	0/72 (0%)	0
hernia pain	0/74 (0%)	0	1/72 (1.4%)	1
hot-cold sweats	1/74 (1.4%)	1	0/72 (0%)	0
lethargic	0/74 (0%)	0	1/72 (1.4%)	1
Immune system disorders
malaise	2/74 (2.7%)	2	4/72 (5.6%)	4
flu like symptoms	0/74 (0%)	0	2/72 (2.8%)	2
insect bite swelling	1/74 (1.4%)	1	0/72 (0%)	0
Infections and infestations
eye infection	0/74 (0%)	0	1/72 (1.4%)	1
infected boil	1/74 (1.4%)	1	0/72 (0%)	0
Injury, poisoning and procedural complications
wrist pain	0/74 (0%)	0	1/72 (1.4%)	1
accidental inury, arm and knuckle	0/74 (0%)	0	1/72 (1.4%)	1
Metabolism and nutrition disorders
decreased appetite	0/74 (0%)	0	1/72 (1.4%)	1
Musculoskeletal and connective tissue disorders
back pain	4/74 (5.4%)	5	1/72 (1.4%)	1
back pain-lower	1/74 (1.4%)	2	0/72 (0%)	0
achey joints	1/74 (1.4%)	1	0/72 (0%)	0
arthritis in leg	1/74 (1.4%)	1	0/72 (0%)	0
body aches	1/74 (1.4%)	1	1/72 (1.4%)	1
hip and left femor ache	0/74 (0%)	0	1/72 (1.4%)	1
foot pain	0/74 (0%)	0	1/72 (1.4%)	1
hip arthrosis	0/74 (0%)	0	1/72 (1.4%)	1
muscle ache	0/74 (0%)	0	1/72 (1.4%)	1
neck pain	1/74 (1.4%)	1	0/72 (0%)	0
Nervous system disorders
headache	6/74 (8.1%)	6	3/72 (4.2%)	3
dizziness	1/74 (1.4%)	1	0/72 (0%)	0
restless	0/74 (0%)	0	1/72 (1.4%)	1
Pregnancy, puerperium and perinatal conditions
miscarriage of pregnancy	0/74 (0%)	0	1/72 (1.4%)	1
pregnancy	0/74 (0%)	0	2/72 (2.8%)	3
Psychiatric disorders
anxiety	6/74 (8.1%)	6	3/72 (4.2%)	3
anxiousness	5/74 (6.8%)	5	0/72 (0%)	0
depression	5/74 (6.8%)	7	2/72 (2.8%)	2
suicidal ideation	0/74 (0%)	0	1/72 (1.4%)	1
insomnia	1/74 (1.4%)	1	1/72 (1.4%)	1
withdrawn feeling	1/74 (1.4%)	1	0/72 (0%)	0
irritable	1/74 (1.4%)	1	0/72 (0%)	0
Renal and urinary disorders
urinary tract infection	1/74 (1.4%)	1	2/72 (2.8%)	2
increased urine	1/74 (1.4%)	1	0/72 (0%)	0
Reproductive system and breast disorders
decreased sex drive	0/74 (0%)	0	1/72 (1.4%)	1
fibrois mass on ovary	1/74 (1.4%)	1	0/72 (0%)	0
Respiratory, thoracic and mediastinal disorders
bronchitis	1/74 (1.4%)	1	1/72 (1.4%)	1
common cold	4/74 (5.4%)	4	2/72 (2.8%)	2
breathing problems	1/74 (1.4%)	1	0/72 (0%)	0
runny nose	1/74 (1.4%)	1	0/72 (0%)	0
breathing abnormality	1/74 (1.4%)	1	0/72 (0%)	0
Surgical and medical procedures
tooth extraction	1/74 (1.4%)	1	0/72 (0%)	0
Vascular disorders
deep vein thrombosis	0/74 (0%)	0	1/72 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.