Trial Outcomes & Findings for Monthly Injectable BUP for MA Use Disorder (MURB) Trial (NCT NCT05283304)
NCT ID: NCT05283304
Last Updated: 2025-03-21
Results Overview
Number of Methamphetamine (MA)-negative Urine Drug Screen (UDS) results obtained during Weeks 9 through 12 of the medication phase is measured for the BUP-Inj and PBO-Inj conditions. Number of UDS results / number of expected UDS results. Two UDS results were expected each week.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
weeks 9-12
Results posted on
2025-03-21
Participant Flow
Of the 18 enrolled participants randomized, 2 withdrew prior to starting sublingual buprenorphine (SL-BUP) induction procedure and only the participants who successfully completed the open-label SL-BUP induction procedure started the Study Medication \[injectable formulation (experimental/placebo)\] as assigned in the table below.
Participant milestones
| Measure |
Injectable Buprenorphine (BUP-inj)
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monthly Injectable BUP for MA Use Disorder (MURB) Trial
Baseline characteristics by cohort
| Measure |
Injectable Buprenorphine (BUP-inj)
n=5 Participants
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=13 Participants
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
Total
n=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weeks 9-12Number of Methamphetamine (MA)-negative Urine Drug Screen (UDS) results obtained during Weeks 9 through 12 of the medication phase is measured for the BUP-Inj and PBO-Inj conditions. Number of UDS results / number of expected UDS results. Two UDS results were expected each week.
Outcome measures
| Measure |
Injectable Buprenorphine (BUP-inj)
n=16 urine samples
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=32 urine samples
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
Number of Methamphetamine-negative Urine Samples
|
0 urine samples
|
0 urine samples
|
SECONDARY outcome
Timeframe: weeks 1-12The TES is defined to be the number of MA negative UDS divided by the number of possible UDS collected during the study. In this study there are 24 possible UDS collections so the number of MA negative UDS is divided by 24. Possible score ranges from 0-24; with higher score indicating better outcome.
Outcome measures
| Measure |
Injectable Buprenorphine (BUP-inj)
n=48 urine samples
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=96 urine samples
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
Treatment Effective Score (TES) for MA-negative UDS Results
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: weeks 1-12Number of days of methamphetamine use during treatment will be measured using Timeline Followback (TLFB) procedure which will be administered to document the participant's self-reported use during Weeks 1-12. Possible scores range from 0-84, with lower scores indicating better outcome.
Outcome measures
| Measure |
Injectable Buprenorphine (BUP-inj)
n=2 Participants
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=4 Participants
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
Number of Days of Methamphetamine Use During the Medication Phase
|
56.0 days
Standard Deviation 25.46
|
53.8 days
Standard Deviation 27.54
|
SECONDARY outcome
Timeframe: weeks 1-12The TES is defined to be the number of UDS results negative for opioids divided by the number of possible UDS collected during the study. In this study there are 24 possible UDS collections, so the number of opioid negative UDS is divided by 24. Possible score ranges from 0-24; with higher score indicating better outcome.
Outcome measures
| Measure |
Injectable Buprenorphine (BUP-inj)
n=48 urine samples
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=96 urine samples
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
Treatment Effective Score (TES) for Opioid Negative UDS Results
|
0.62 score on a scale
Interval 0.5 to 0.75
|
0.75 score on a scale
Interval 0.48 to 0.9
|
SECONDARY outcome
Timeframe: weeks 1-12Number of days of opioid use during treatment will be measured using Timeline Followback (TLFB) procedure which will be administered to document the participant's self-reported opioid use at week 12. Possible scores range from 0-84, with lower scores indicating better outcome.
Outcome measures
| Measure |
Injectable Buprenorphine (BUP-inj)
n=2 Participants
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=4 Participants
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
Number of Days of Opioid Use During the Medication Phase
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: weeks 1-12The TES is defined to be the number of MA and Opioid Co-Use negative UDS divided by the number of possible UDS collected during the study. In this study there are 24 possible UDS collections, so the number of MA and Opioid Co-Use negative UDS is divided by 24. Possible score ranges from 0-24; with higher score indicating better outcome.
Outcome measures
| Measure |
Injectable Buprenorphine (BUP-inj)
n=48 urine samples
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=96 urine samples
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
Treatment Effective Score (TES) for MA and Opioid Co-Use Compiled
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: weeks 1-12Number of days of MA and opioid co-use during treatment will be measured using Timeline Followback (TLFB) procedure which will be administered to document the participant's self-reported use of substances for each day at week 12. Possible scores range from 0-84, with lower scores indicating better outcome.
Outcome measures
| Measure |
Injectable Buprenorphine (BUP-inj)
n=2 Participants
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=4 Participants
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
Number of Days of MA and Opioid Co-use During the Medication Phase
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
Adverse Events
Injectable Buprenorphine (BUP-inj)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Injectable Placebo (PBO-inj)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Injectable Buprenorphine (BUP-inj)
n=5 participants at risk
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=13 participants at risk
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic and hypercapnic respiratory failure
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
0.00%
0/13 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
Other adverse events
| Measure |
Injectable Buprenorphine (BUP-inj)
n=5 participants at risk
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Buprenorphine injection (BUP-Inj): Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
|
Injectable Placebo (PBO-inj)
n=13 participants at risk
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Placebo injection: Sublingual buprenorphine induction, then Placebo injectable (300 mg)
|
|---|---|---|
|
General disorders
Adverse Drug Reaction
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
0.00%
0/13 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Psychiatric disorders
Mental Status Changes
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
0.00%
0/13 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
23.1%
3/13 • Number of events 3 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
30.8%
4/13 • Number of events 4 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
30.8%
4/13 • Number of events 4 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 4 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
30.8%
4/13 • Number of events 4 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
General disorders
Pain
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
15.4%
2/13 • Number of events 2 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Investigations
Electrocardiogram ST Segment elevation
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Nervous system disorders
Somnolence
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
15.4%
2/13 • Number of events 2 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
60.0%
3/5 • Number of events 3 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
0.00%
0/13 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Ear and labyrinth disorders
Tinnitis
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
23.1%
3/13 • Number of events 3 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/5 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
7.7%
1/13 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Injury, poisoning and procedural complications
Chemical Burn on Skin
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
0.00%
0/13 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
0.00%
0/13 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
0.00%
0/13 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Infections and infestations
Urethritis
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
0.00%
0/13 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
|
Infections and infestations
Oropharyngeal Gonococcal Infection
|
20.0%
1/5 • Number of events 1 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
0.00%
0/13 • Adverse event assessment will initiate with participant written informed consent to 30 days post last study visit (approximately 19 weeks).
All Adverse events that occurred during the sublingual buprenorphine (SL-BUP) induction period for all randomized subjects as well as the subjects who continued to study medication period (injectable formulation-experimental/ placebo) are reported here. Hence, the number of participants at risk is greater than the number started study medication in Participant flow module.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place