Trial Outcomes & Findings for Cocaine Use Reduction With Buprenorphine (NCT NCT01402492)
NCT ID: NCT01402492
Last Updated: 2021-10-29
Results Overview
Self-reported days of cocaine use corroborated with urine drug screens (UDS).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
302 participants
Primary outcome timeframe
final 30 days of Treatment Phase, study days 25-54
Results posted on
2021-10-29
Participant Flow
Participant milestones
| Measure |
BUP4+XR-NTX
4mg buprenorphine plus naltrexone for 8 weeks of treatment
|
BUP16+XR-NTX
16mg buprenorphine plus naltrexone for 8 weeks of treatment
|
PLB+XR-NTX
Placebo plus naltrexone for 8 weeks of treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
102
|
|
Overall Study
COMPLETED
|
79
|
83
|
86
|
|
Overall Study
NOT COMPLETED
|
21
|
17
|
16
|
Reasons for withdrawal
| Measure |
BUP4+XR-NTX
4mg buprenorphine plus naltrexone for 8 weeks of treatment
|
BUP16+XR-NTX
16mg buprenorphine plus naltrexone for 8 weeks of treatment
|
PLB+XR-NTX
Placebo plus naltrexone for 8 weeks of treatment
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
11
|
11
|
|
Overall Study
Adverse Event
|
2
|
3
|
4
|
|
Overall Study
Physician Decision
|
0
|
3
|
0
|
|
Overall Study
Incarcerated (N=3)
|
2
|
0
|
1
|
Baseline Characteristics
Cocaine Use Reduction With Buprenorphine
Baseline characteristics by cohort
| Measure |
BUP4+XR-NTX
n=100 Participants
4mg buprenorphine plus naltrexone for 8 weeks of treatment
|
BUP16+XR-NTX
n=100 Participants
16mg buprenorphine plus naltrexone for 8 weeks of treatment
|
PLB+XR-NTX
n=102 Participants
Placebo plus naltrexone for 8 weeks of treatment
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
302 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 10.08 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 8.63 • n=4 Participants
|
|
Age, Customized
18-24
|
0 years
n=5 Participants
|
3 years
n=7 Participants
|
0 years
n=5 Participants
|
3 years
n=4 Participants
|
|
Age, Customized
25-34
|
9 years
n=5 Participants
|
14 years
n=7 Participants
|
7 years
n=5 Participants
|
30 years
n=4 Participants
|
|
Age, Customized
35-44
|
27 years
n=5 Participants
|
19 years
n=7 Participants
|
26 years
n=5 Participants
|
72 years
n=4 Participants
|
|
Age, Customized
45-54
|
46 years
n=5 Participants
|
45 years
n=7 Participants
|
55 years
n=5 Participants
|
146 years
n=4 Participants
|
|
Age, Customized
55-64
|
18 years
n=5 Participants
|
19 years
n=7 Participants
|
14 years
n=5 Participants
|
51 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
237 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
100 participants
n=7 Participants
|
102 participants
n=5 Participants
|
302 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: final 30 days of Treatment Phase, study days 25-54Self-reported days of cocaine use corroborated with urine drug screens (UDS).
Outcome measures
| Measure |
BUP4+XR-NTX
n=100 Participants
4mg buprenorphine plus naltrexone for 8 weeks of treatment
|
BUP16+XR-NTX
n=100 Participants
16mg buprenorphine plus naltrexone for 8 weeks of treatment
|
PLB+XR-NTX
n=102 Participants
Placebo plus naltrexone for 8 weeks of treatment
|
|---|---|---|---|
|
Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens
|
6.6 days of cocaine use
Standard Deviation 5.25
|
7.2 days of cocaine use
Standard Deviation 6.77
|
7.7 days of cocaine use
Standard Deviation 6.16
|
Adverse Events
BUP4+XR-NTX
Serious events: 13 serious events
Other events: 66 other events
Deaths: 0 deaths
BUP16+XR-NTX
Serious events: 8 serious events
Other events: 64 other events
Deaths: 0 deaths
PLB+XR-NTX
Serious events: 12 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BUP4+XR-NTX
n=100 participants at risk
4mg buprenorphine plus naltrexone for 8 weeks of treatment
|
BUP16+XR-NTX
n=100 participants at risk
16mg buprenorphine plus naltrexone for 8 weeks of treatment
|
PLB+XR-NTX
n=102 participants at risk
Placebo plus naltrexone for 8 weeks of treatment
|
|---|---|---|---|
|
Psychiatric disorders
Depression
|
1.0%
1/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Psychiatric disorders
Suicidal Behavior
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Psychiatric disorders
Psychotic Disorder
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Pancreatitis
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Surgical and medical procedures
Drug Detoxification
|
2.0%
2/100
|
1.0%
1/100
|
0.98%
1/102
|
|
Surgical and medical procedures
Dialysis
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Infections and infestations
Sinusitis
|
0.00%
0/100
|
2.0%
2/100
|
0.00%
0/102
|
|
Infections and infestations
Wound Infection Staphylococcal
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Infections and infestations
Cellulitis
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
General disorders
Chest Pain
|
2.0%
2/100
|
0.00%
0/100
|
0.00%
0/102
|
|
General disorders
Non-Cardiac Chest Pain
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
General disorders
Cardiac Death
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Spine
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Skin and subcutaneous tissue disorders
Acute Febrile Neutrophilic Dermatosis
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
Other adverse events
| Measure |
BUP4+XR-NTX
n=100 participants at risk
4mg buprenorphine plus naltrexone for 8 weeks of treatment
|
BUP16+XR-NTX
n=100 participants at risk
16mg buprenorphine plus naltrexone for 8 weeks of treatment
|
PLB+XR-NTX
n=102 participants at risk
Placebo plus naltrexone for 8 weeks of treatment
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
28.0%
28/100
|
32.0%
32/100
|
20.6%
21/102
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
12/100
|
15.0%
15/100
|
7.8%
8/102
|
|
Gastrointestinal disorders
Constipation
|
10.0%
10/100
|
10.0%
10/100
|
8.8%
9/102
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
3/100
|
9.0%
9/100
|
7.8%
8/102
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/100
|
3.0%
3/100
|
2.0%
2/102
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/100
|
3.0%
3/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Toothache
|
1.0%
1/100
|
3.0%
3/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
2.0%
2/100
|
1.0%
1/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.0%
1/100
|
2.0%
2/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Sensitivity of Teeth
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Pancreatitis
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Faeces Hard
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Nervous system disorders
Dizziness
|
10.0%
10/100
|
9.0%
9/100
|
3.9%
4/102
|
|
Nervous system disorders
Headache
|
9.0%
9/100
|
6.0%
6/100
|
4.9%
5/102
|
|
Nervous system disorders
Somnolence
|
3.0%
3/100
|
4.0%
4/100
|
3.9%
4/102
|
|
Nervous system disorders
Tremor
|
1.0%
1/100
|
1.0%
1/100
|
0.98%
1/102
|
|
Nervous system disorders
Sedation
|
0.00%
0/100
|
2.0%
2/100
|
0.98%
1/102
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/100
|
2.0%
2/100
|
0.00%
0/102
|
|
Nervous system disorders
Dysgeusia
|
1.0%
1/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Nervous system disorders
Sciatica
|
1.0%
1/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Nervous system disorders
Lethargy
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Nervous system disorders
Depressed Level of Consciousness
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Nervous system disorders
Tension Headache
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Nervous system disorders
Aura
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Nervous system disorders
Parosmia
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Psychiatric disorders
Insomnia
|
4.0%
4/100
|
5.0%
5/100
|
2.0%
2/102
|
|
Psychiatric disorders
Depression
|
3.0%
3/100
|
2.0%
2/100
|
2.0%
2/102
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/100
|
5.0%
5/100
|
0.00%
0/102
|
|
Psychiatric disorders
Libido Decreased
|
2.0%
2/100
|
0.00%
0/100
|
2.9%
3/102
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/100
|
3.0%
3/100
|
2.0%
2/102
|
|
Psychiatric disorders
Euphoric Mood
|
1.0%
1/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Psychiatric disorders
Depressed Mood
|
1.0%
1/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Psychiatric disorders
Sleep Disorder
|
1.0%
1/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Psychiatric disorders
Restlessness
|
1.0%
1/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Psychiatric disorders
Intentional Self-injury
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Psychiatric disorders
Drug Dependence
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Psychiatric disorders
Disorentation
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Psychiatric disorders
Suicidal Behavior
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Psychiatric disorders
Substance-induced Mood Disorder
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Psychiatric disorders
Psychotic Disorder
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Psychiatric disorders
Panic Attack
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
General disorders
Fatigue
|
9.0%
9/100
|
6.0%
6/100
|
3.9%
4/102
|
|
General disorders
Drug Withdrawal Syndrome
|
2.0%
2/100
|
2.0%
2/100
|
2.9%
3/102
|
|
General disorders
Irritability
|
3.0%
3/100
|
0.00%
0/100
|
0.00%
0/102
|
|
General disorders
Chest Pain
|
2.0%
2/100
|
0.00%
0/100
|
0.98%
1/102
|
|
General disorders
Non-cardiac Chest Pain
|
2.0%
2/100
|
0.00%
0/100
|
0.00%
0/102
|
|
General disorders
Influenza-like Illness
|
0.00%
0/100
|
2.0%
2/100
|
0.00%
0/102
|
|
General disorders
Sluggishness
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
General disorders
Asthenia
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
3/100
|
2.0%
2/100
|
2.9%
3/102
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
2/100
|
2.0%
2/100
|
2.0%
2/102
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
1/100
|
1.0%
1/100
|
0.98%
1/102
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.0%
1/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
1/100
|
1.0%
1/100
|
2.9%
3/102
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/100
|
3.0%
3/100
|
0.00%
0/102
|
|
Infections and infestations
Sinusitis
|
0.00%
0/100
|
2.0%
2/100
|
0.98%
1/102
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/100
|
0.00%
0/100
|
2.0%
2/102
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Infections and infestations
Periorbital Infection
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Infections and infestations
Haemophilus Infection
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Infections and infestations
Cellulitis
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Infections and infestations
Wound Infection Staphylococcal
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.0%
3/100
|
5.0%
5/100
|
0.98%
1/102
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/100
|
3.0%
3/100
|
0.00%
0/102
|
|
Skin and subcutaneous tissue disorders
Cold Sweats
|
1.0%
1/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Skin and subcutaneous tissue disorders
Acute Febrile Neutrophilic Dermatosis
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Respiratory, thoracic and mediastinal disorders
Astma
|
2.0%
2/100
|
2.0%
2/100
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.0%
1/100
|
1.0%
1/100
|
0.98%
1/102
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
1/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Metabolism and nutrition disorders
Decreased Appetitie
|
4.0%
4/100
|
3.0%
3/100
|
2.0%
2/102
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/100
|
2.0%
2/100
|
0.00%
0/102
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Laceration
|
1.0%
1/100
|
0.00%
0/100
|
2.0%
2/102
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Injury, poisoning and procedural complications
Post-traumatic Neck Syndrome
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Injury, poisoning and procedural complications
Post-lumbar Puncture Syndrome
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Surgical and medical procedures
Drug Detoxification
|
2.0%
2/100
|
1.0%
1/100
|
0.98%
1/102
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Surgical and medical procedures
Dialysis
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Investigations
Weight Increased
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Investigations
Urine Analysis Abnormal
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Investigations
Liver Function Test Abnormal
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Investigations
International Normalized Ratio Increased
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Vascular disorders
Hot Flush
|
1.0%
1/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Vascular disorders
Hypertension
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Spine
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Immune system disorders
Seasonal Allergy
|
2.0%
2/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Ear and labyrinth disorders
Ear Pain
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/100
|
0.00%
0/100
|
0.98%
1/102
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/100
|
1.0%
1/100
|
0.00%
0/102
|
|
Eye disorders
Lacrimation Increased
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Endocrine disorders
Hyperthyrodism
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Endocrine disorders
Adrenal Mass
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
|
Blood and lymphatic system disorders
Monocytosis
|
1.0%
1/100
|
0.00%
0/100
|
0.00%
0/102
|
Additional Information
Walter Ling, MD
UCLA Integrated Substance Abuse Programs
Phone: 310-267-5888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results. The sponsor can require changes to the communication and can extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER