Trial Outcomes & Findings for Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (NCT NCT02032433)
NCT ID: NCT02032433
Last Updated: 2020-08-13
Results Overview
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
COMPLETED
PHASE4
570 participants
Weeks 3-24
2020-08-13
Participant Flow
Participant milestones
| Measure |
Extended-Release Naltrexone
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Overall Study
STARTED
|
283
|
287
|
|
Overall Study
COMPLETED
|
205
|
225
|
|
Overall Study
NOT COMPLETED
|
78
|
62
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Baseline characteristics by cohort
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
Total
n=570 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
195 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
238 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
471 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 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
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
206 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Randomization status
Early randomization
|
107 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Randomization status
Late randomization
|
176 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 3-24Population: Intention to treat.
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Time to Relapse (Intent to Treat Population)
|
8.4 weeks
Interval 3.0 to 23.4
|
14.4 weeks
Interval 5.1 to 23.4
|
PRIMARY outcome
Timeframe: Weeks 3-24Population: Per protocol population (those successfully inducted onto medication)
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=204 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=270 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Time to Relapse (Per Protocol Population)
|
20.4 weeks
Interval 5.4 to 23.4
|
15.2 weeks
Interval 5.7 to 23.4
|
SECONDARY outcome
Timeframe: Weeks 0-24Population: Intent to treat
Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Number Successfully Inducted Onto Assigned Study Medication
|
204 participants
|
270 participants
|
SECONDARY outcome
Timeframe: Weeks 0-36Population: These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication.
Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=204 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=270 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Adverse Events Related to Study Medications
|
115 events
|
113 events
|
SECONDARY outcome
Timeframe: Weeks 0-24Population: per protocol
Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=204 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=270 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Opioid Abstinence Over Time While on Study Medication (Subjective)
|
123 days
Interval 18.0 to 144.0
|
87 days
Interval 20.0 to 144.0
|
SECONDARY outcome
Timeframe: Week 0Alcohol use over time, drinks per day, past 30 days, at week 0
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0
|
.8 drinks per day
Standard Deviation 2.41
|
1.2 drinks per day
Standard Deviation 3.75
|
SECONDARY outcome
Timeframe: Week 0Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking, W0, 10 or Less
|
112 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: Week 0Opioid craving over time via VAS at week 0
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Opioid Craving Over Time W0
|
68.7 score on a scale
Standard Deviation 30.55
|
68.8 score on a scale
Standard Deviation 30.05
|
SECONDARY outcome
Timeframe: Week 0The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
|
8.6 score on a scale
Standard Deviation 6.45
|
9.3 score on a scale
Standard Deviation 6.63
|
SECONDARY outcome
Timeframe: Week 0The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
|
.1 score on a scale
Standard Deviation .2
|
.1 score on a scale
Standard Deviation .23
|
SECONDARY outcome
Timeframe: Week 0The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
|
5.5 score on a scale
Standard Deviation 8.85
|
5.9 score on a scale
Standard Deviation 10.46
|
SECONDARY outcome
Timeframe: Week 0Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Trail Making Test Part A
|
26.8 seconds
Standard Deviation 11.09
|
25.8 seconds
Standard Deviation 10.07
|
SECONDARY outcome
Timeframe: Weeks 0-24Population: Per protocol
A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=204 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=270 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Opioid Abstinence Over Time While on Study Medication (Objective)
|
13 Weeks
Interval 3.0 to 21.0
|
11 Weeks
Interval 3.0 to 20.0
|
SECONDARY outcome
Timeframe: Week 0Participants average cigarettes/day, in past 4 weeks, at week 0, equals none
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking, W0 0
|
17 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Week 0Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking, W0 11-20
|
106 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: Week 0Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking, W0 21-30
|
18 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Week 0Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking, W0 31 or More
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 24Participants average cigarettes/day, in past 4 weeks, at week 24, equals none
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking, W24 0
|
32 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Week 24Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking
|
70 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Week 24Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking, W24 11-20
|
57 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Week 24Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking, W24 21-30
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 24Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Cigarette Smoking, W24 31 or More
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 24OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Opioid Craving Scale (OCS)
|
9.9 score on a scale
Standard Deviation 21.54
|
9.4 score on a scale
Standard Deviation 17.67
|
SECONDARY outcome
Timeframe: Week 24The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
|
5.2 score on a scale
Standard Deviation 6.53
|
4.8 score on a scale
Standard Deviation 5.48
|
SECONDARY outcome
Timeframe: Week 0The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Subjective Opiate Withdrawal Scale (SOWS)
|
15.6 score on a scale
Standard Deviation 13.38
|
15.6 score on a scale
Standard Deviation 13.15
|
SECONDARY outcome
Timeframe: Week 24The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Subjective Opiate Withdrawal Scale (SOWS)
|
4.5 score on a scale
Standard Deviation 7.53
|
5.3 score on a scale
Standard Deviation 7.49
|
SECONDARY outcome
Timeframe: Week 24The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
|
7.3 score on a scale
Standard Deviation 9.37
|
6.0 score on a scale
Standard Deviation 10.63
|
SECONDARY outcome
Timeframe: Week 0The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
|
3.6 score on a scale
Standard Deviation 7.34
|
4.3 score on a scale
Standard Deviation 10.07
|
SECONDARY outcome
Timeframe: Week 24The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
|
4.8 score on a scale
Standard Deviation 8.4
|
4.3 score on a scale
Standard Deviation 10.34
|
SECONDARY outcome
Timeframe: Week 24Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Trail Making Test Part A
|
21.6 seconds
Standard Deviation 9.81
|
20.3 seconds
Standard Deviation 7.03
|
SECONDARY outcome
Timeframe: Week 0Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Trail Making Test Part B
|
79.1 seconds
Standard Deviation 40.19
|
78.3 seconds
Standard Deviation 40.73
|
SECONDARY outcome
Timeframe: Week 24Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Trail Making Test Part B
|
61.2 seconds
Standard Deviation 39.32
|
58.1 seconds
Standard Deviation 33.37
|
SECONDARY outcome
Timeframe: Week 0The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Word Card of Stoop Test
|
95.8 seconds
Standard Deviation 16.6
|
96.4 seconds
Standard Deviation 16.03
|
SECONDARY outcome
Timeframe: Week 24The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Word Card of Stoop Test
|
103.2 seconds
Standard Deviation 18.02
|
102.9 seconds
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Week 0The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Color Card of Stoop Test
|
69.3 seconds
Standard Deviation 13.63
|
70.5 seconds
Standard Deviation 12.46
|
SECONDARY outcome
Timeframe: Week 24The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Color Card of Stoop Test
|
75.3 seconds
Standard Deviation 15.31
|
76.1 seconds
Standard Deviation 14.84
|
SECONDARY outcome
Timeframe: Week 0The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Color Word Card of Stoop Test
|
41.1 seconds
Standard Deviation 10.33
|
42.2 seconds
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: Week 24The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on Color Word Card of Stoop Test
|
47.6 seconds
Standard Deviation 12.07
|
48.8 seconds
Standard Deviation 12.35
|
SECONDARY outcome
Timeframe: Week 24The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
|
.1 score on a scale
Standard Deviation .11
|
0.0 score on a scale
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Week 0The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
|
0.3 score on a scale
Standard Deviation 0.08
|
.3 score on a scale
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Week 24The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
|
.1 score on a scale
Standard Deviation .13
|
.1 score on a scale
Standard Deviation .12
|
SECONDARY outcome
Timeframe: Week 0The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
|
.3 score on a scale
Standard Deviation .25
|
.3 score on a scale
Standard Deviation .24
|
SECONDARY outcome
Timeframe: Week 24The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
|
.1 score on a scale
Standard Deviation .18
|
.1 score on a scale
Standard Deviation .19
|
SECONDARY outcome
Timeframe: Week 0The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
|
.2 score on a scale
Standard Deviation .21
|
.2 score on a scale
Standard Deviation .21
|
SECONDARY outcome
Timeframe: Week 24The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
|
.1 score on a scale
Standard Deviation .17
|
.1 score on a scale
Standard Deviation .17
|
SECONDARY outcome
Timeframe: Week 0The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
|
.2 score on a scale
Standard Deviation .25
|
.2 score on a scale
Standard Deviation .27
|
SECONDARY outcome
Timeframe: Week 24The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
|
.1 score on a scale
Standard Deviation .24
|
.2 score on a scale
Standard Deviation .25
|
SECONDARY outcome
Timeframe: Week 0The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
|
.3 score on a scale
Standard Deviation .22
|
.3 score on a scale
Standard Deviation .22
|
SECONDARY outcome
Timeframe: Week 24The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
|
.2 score on a scale
Standard Deviation .21
|
.2 score on a scale
Standard Deviation .21
|
SECONDARY outcome
Timeframe: Week 0Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on EuroQOL EQ-5D Questionnaire
|
6.8 score on a scale
Standard Deviation 1.44
|
6.8 score on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Week 24Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Score on EuroQOL EQ-5D Questionnaire
|
5.8 score on a scale
Standard Deviation 1.15
|
6.1 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Week 24Alcohol use over time, drinks per day
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Alcohol Use Over Time, Drinks Per Day
|
.1 drinks per day
Standard Deviation .82
|
.4 drinks per day
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: week 0Other drug use over time measuring cannabis at week 0
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Other Drug Use Over Time, Cannabis, W0
|
123 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: week 24Other drug use over time measuring cannabis at week 24
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Other Drug Use Over Time, Cannabis, W24
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: week 0Other drug use over time measuring cocaine at week 0
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Other Drug Use Over Time, Cocaine, W0
|
61 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: week 24Other drug use over time measuring cocaine at week 0
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Other Drug Use Over Time, Cocaine, W24
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: week 0Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Other Drug Use Over Time, Stimulant, W0
|
132 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: week 24Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24
Outcome measures
| Measure |
Extended-Release Naltrexone
n=283 Participants
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 Participants
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Other Drug Use Over Time, Stimulant, W24
|
5 Participants
|
3 Participants
|
Adverse Events
Extended-Release Naltrexone
Buprenorphine-Naloxone
Serious adverse events
| Measure |
Extended-Release Naltrexone
n=283 participants at risk
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 participants at risk
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Infections and infestations
Infections and infestations
|
2.5%
7/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
2.1%
6/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.37%
1/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
6.0%
17/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
3.0%
8/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
General disorders
General disorders and administration site conditions
|
0.71%
2/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.74%
2/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.74%
2/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
1.8%
5/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.00%
0/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Nervous system disorders
Nervous system disorders
|
0.71%
2/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.74%
2/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.37%
1/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.00%
0/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.00%
0/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.37%
1/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Eye disorders
Eye disorders
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.00%
0/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.00%
0/270 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Psychiatric disorders
Psychiatric
|
3.5%
10/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
4.2%
12/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
Other adverse events
| Measure |
Extended-Release Naltrexone
n=283 participants at risk
Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
|
Buprenorphine-Naloxone
n=287 participants at risk
Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
12.7%
36/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
20.2%
58/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Psychiatric disorders
Psychiatric
|
10.2%
29/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
7.7%
22/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Injury, poisoning and procedural complications
Injury poisoning and procedural complications
|
6.4%
18/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
7.7%
22/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Infections and infestations
Infections and infestations
|
7.8%
22/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
7.7%
22/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Nervous system disorders
Nervous system disorders
|
10.2%
29/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
9.4%
27/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
General disorders
General Disorders and Administration Site Conditions
|
3.5%
10/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
7.3%
21/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
5.7%
16/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
5.2%
15/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Investigations
Investigations
|
3.5%
10/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
3.8%
11/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.5%
7/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
2.4%
7/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
3.2%
9/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
2.4%
7/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition
|
2.1%
6/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
1.4%
4/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Eye disorders
Eye disorders
|
2.1%
6/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
1.0%
3/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.4%
4/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
1.7%
5/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Vascular disorders
Vascular disorders
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
2.1%
6/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.71%
2/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
1.0%
3/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.00%
0/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
1.0%
3/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Hepatobiliary disorders
Hepatbiliary disorders
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.35%
1/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.35%
1/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Immune system disorders
Immune system disorders
|
0.00%
0/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.35%
1/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Cardiac disorders
Cardiac disorders
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.00%
0/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Social circumstances
Social circumstances
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.00%
0/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.35%
1/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.00%
0/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
|
Product Issues
Product issues
|
0.00%
0/283 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
0.35%
1/287 • Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place