Trial Outcomes & Findings for Extended Release Naltrexone for Opioid-Dependent Youth (NCT NCT01843023)
NCT ID: NCT01843023
Last Updated: 2021-11-10
Results Overview
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
288 participants
Primary outcome timeframe
6 months
Results posted on
2021-11-10
Participant Flow
Participant milestones
| Measure |
Extended Release Naltrexone
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
|
Treatment as Usual
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
144
|
|
Overall Study
3 Months
|
110
|
114
|
|
Overall Study
COMPLETED
|
111
|
109
|
|
Overall Study
NOT COMPLETED
|
33
|
35
|
Reasons for withdrawal
| Measure |
Extended Release Naltrexone
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
|
Treatment as Usual
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
24
|
29
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
Baseline Characteristics
Extended Release Naltrexone for Opioid-Dependent Youth
Baseline characteristics by cohort
| Measure |
Extended Release Naltrexone
n=144 Participants
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
|
Treatment as Usual
n=144 Participants
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
127 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
19.18 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
19.46 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
19.32 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
118 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
144 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Self-reported opioid use past 90 days
|
65.71 days
STANDARD_DEVIATION 23.2 • n=5 Participants
|
63.19 days
STANDARD_DEVIATION 23.5 • n=7 Participants
|
64.45 days
STANDARD_DEVIATION 23.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry.
Outcome measures
| Measure |
Extended Release Naltrexone
n=111 Participants
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
|
Treatment as Usual
n=109 Participants
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
|
|---|---|---|
|
Opioid Use at 6 Month Follow-up
|
19.63 days
Standard Error 2.55
|
18.42 days
Standard Error 2.68
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed 6-month follow-up assessment with complete data.
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of days in treatment. Treatment defined as medications for OUD received in past 30 days at 6-month follow-up.
Outcome measures
| Measure |
Extended Release Naltrexone
n=109 Participants
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
|
Treatment as Usual
n=109 Participants
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
|
|---|---|---|
|
Treatment Retention
|
5.53 days
Standard Deviation 11.07
|
4.69 days
Standard Deviation 10.16
|
SECONDARY outcome
Timeframe: 6 monthsThe cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization at 6 months.
Outcome measures
| Measure |
Extended Release Naltrexone
n=140 Participants
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
|
Treatment as Usual
n=142 Participants
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
|
|---|---|---|
|
Monetized Healthcare Utilization
|
8136 dollars
Standard Error 646.07
|
6629 dollars
Standard Error 602.55
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed 6-month follow-up assessment.
To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months. Past 90 days self-reported HIV sex risk behaviors on the Risk Assessment Battery (RAB). Minimum value 0; maximum value 24. Higher scores reflect endorsement of more risk behaviors (worse outcome).
Outcome measures
| Measure |
Extended Release Naltrexone
n=111 Participants
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
|
Treatment as Usual
n=109 Participants
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
|
|---|---|---|
|
HIV Sex Risk Behaviors
|
3.53 score on a scale
Standard Deviation 2.23
|
3.42 score on a scale
Standard Deviation 2.34
|
Adverse Events
Extended Release Naltrexone
Serious events: 5 serious events
Other events: 132 other events
Deaths: 1 deaths
Treatment as Usual
Serious events: 5 serious events
Other events: 122 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extended Release Naltrexone
n=144 participants at risk
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
|
Treatment as Usual
n=144 participants at risk
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
|
|---|---|---|
|
Hepatobiliary disorders
Acute Hepatitis
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Infections and infestations
Infection
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.69%
1/144 • Number of events 1 • 6 months
|
1.4%
2/144 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Amputation
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Psychiatric disorders
Mood Instability
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Suicidal Ideation
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Epidural Hematoma
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Extended Release Naltrexone
n=144 participants at risk
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
|
Treatment as Usual
n=144 participants at risk
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.69%
1/144 • Number of events 1 • 6 months
|
4.9%
7/144 • Number of events 7 • 6 months
|
|
Endocrine disorders
Seizure
|
1.4%
2/144 • Number of events 3 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Endocrine disorders
Hypoglycemia
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.6%
11/144 • Number of events 13 • 6 months
|
7.6%
11/144 • Number of events 11 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.69%
1/144 • Number of events 1 • 6 months
|
3.5%
5/144 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
3/144 • Number of events 3 • 6 months
|
3.5%
5/144 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
10.4%
15/144 • Number of events 17 • 6 months
|
11.1%
16/144 • Number of events 18 • 6 months
|
|
Gastrointestinal disorders
Vomitting
|
8.3%
12/144 • Number of events 14 • 6 months
|
10.4%
15/144 • Number of events 16 • 6 months
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Root Canal Infection
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Gastrointestinal disorders
Toothache
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
General disorders
Hot flush
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
General disorders
Injection site bruising
|
2.8%
4/144 • Number of events 6 • 6 months
|
2.8%
4/144 • Number of events 4 • 6 months
|
|
General disorders
Injection site erythema
|
1.4%
2/144 • Number of events 4 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
General disorders
Injection site mass
|
8.3%
12/144 • Number of events 16 • 6 months
|
7.6%
11/144 • Number of events 14 • 6 months
|
|
General disorders
Injection site pain
|
12.5%
18/144 • Number of events 26 • 6 months
|
9.7%
14/144 • Number of events 20 • 6 months
|
|
General disorders
Injection site pruritus
|
1.4%
2/144 • Number of events 4 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
General disorders
Injection site swelling
|
3.5%
5/144 • Number of events 8 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
General disorders
Pyrexia
|
0.00%
0/144 • 6 months
|
3.5%
5/144 • Number of events 5 • 6 months
|
|
General disorders
Pain
|
6.2%
9/144 • Number of events 10 • 6 months
|
7.6%
11/144 • Number of events 12 • 6 months
|
|
Hepatobiliary disorders
Dark urine
|
6.9%
10/144 • Number of events 11 • 6 months
|
6.2%
9/144 • Number of events 9 • 6 months
|
|
Hepatobiliary disorders
Hepatitis C
|
1.4%
2/144 • Number of events 2 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Jaundice
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Hepatobiliary disorders
Liver function test
|
2.1%
3/144 • Number of events 3 • 6 months
|
0.00%
0/144 • 6 months
|
|
Immune system disorders
Multiple Allergies
|
4.2%
6/144 • Number of events 6 • 6 months
|
1.4%
2/144 • Number of events 2 • 6 months
|
|
Infections and infestations
Infection
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Overdose
|
7.6%
11/144 • Number of events 11 • 6 months
|
8.3%
12/144 • Number of events 13 • 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
12/144 • Number of events 12 • 6 months
|
11.8%
17/144 • Number of events 17 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Amputation
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
2.8%
4/144 • Number of events 5 • 6 months
|
5.6%
8/144 • Number of events 8 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Ligament Sprain
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
18/144 • Number of events 22 • 6 months
|
10.4%
15/144 • Number of events 17 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Tingling in arm
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Nervous system disorders
Cold stimulus headache
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Nervous system disorders
Dizziness
|
2.8%
4/144 • Number of events 4 • 6 months
|
4.2%
6/144 • Number of events 6 • 6 months
|
|
Nervous system disorders
Epidural Hemorrage
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Nervous system disorders
Headache
|
19.4%
28/144 • Number of events 38 • 6 months
|
20.1%
29/144 • Number of events 36 • 6 months
|
|
Pregnancy, puerperium and perinatal conditions
Unintended Pregnancy
|
2.1%
3/144 • Number of events 3 • 6 months
|
0.00%
0/144 • 6 months
|
|
Psychiatric disorders
Anxiety
|
16.0%
23/144 • Number of events 25 • 6 months
|
20.8%
30/144 • Number of events 33 • 6 months
|
|
Psychiatric disorders
Depression
|
13.2%
19/144 • Number of events 20 • 6 months
|
16.0%
23/144 • Number of events 25 • 6 months
|
|
Psychiatric disorders
Drug withdrawal syndrome
|
36.8%
53/144 • Number of events 68 • 6 months
|
36.1%
52/144 • Number of events 65 • 6 months
|
|
Psychiatric disorders
Acute intoxication
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Hospitalized for observation
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.00%
0/144 • 6 months
|
|
Psychiatric disorders
Insomnia
|
23.6%
34/144 • Number of events 43 • 6 months
|
26.4%
38/144 • Number of events 45 • 6 months
|
|
Psychiatric disorders
Irritability
|
10.4%
15/144 • Number of events 18 • 6 months
|
11.8%
17/144 • Number of events 18 • 6 months
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Nervousness
|
4.2%
6/144 • Number of events 6 • 6 months
|
2.8%
4/144 • Number of events 4 • 6 months
|
|
Psychiatric disorders
Suicidal Ideation
|
2.1%
3/144 • Number of events 3 • 6 months
|
5.6%
8/144 • Number of events 8 • 6 months
|
|
Psychiatric disorders
Intentional Self Injury
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/144 • 6 months
|
1.4%
2/144 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/144 • 6 months
|
1.4%
2/144 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
4.2%
6/144 • Number of events 6 • 6 months
|
7.6%
11/144 • Number of events 11 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
1.4%
2/144 • Number of events 2 • 6 months
|
4.2%
6/144 • Number of events 6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.6%
11/144 • Number of events 11 • 6 months
|
7.6%
11/144 • Number of events 13 • 6 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Formication
|
0.00%
0/144 • 6 months
|
1.4%
2/144 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.69%
1/144 • Number of events 1 • 6 months
|
2.1%
3/144 • Number of events 3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
4/144 • Number of events 4 • 6 months
|
5.6%
8/144 • Number of events 8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/144 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
|
Vascular disorders
Contusion
|
2.8%
4/144 • Number of events 4 • 6 months
|
1.4%
2/144 • Number of events 2 • 6 months
|
|
Vascular disorders
Epistaxis
|
1.4%
2/144 • Number of events 2 • 6 months
|
2.1%
3/144 • Number of events 3 • 6 months
|
|
Vascular disorders
Hypertension
|
0.69%
1/144 • Number of events 1 • 6 months
|
0.69%
1/144 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place