Trial Outcomes & Findings for SUBLOCADE Rapid Initiation Study (NCT NCT03993392)

Last Updated: 2025-03-25

Results Overview

Clinical Opiate Withdrawal Scale (COWS) is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Precipitated withdrawal was defined as in increase in Clinical Opioid Withdrawal Scale (COWS) score by ≥6 from the pre-SUBLOCADE value within 1 hour SUBLOCADE injection.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

Day 1: Pre-SUBLOCADE evaluation taken after TM buprenorphine treatment and prior to injection: SUBLOCADE evaluation taken within one hour of SUBLOCADE injection

Results posted on

2025-03-25

Participant Flow

A total of 49 participants were screened and a total of 26 (53.1%) were enrolled into the study (i.e., were administered TM buprenorphine in the induction phase).

Reasons not enrolled: * 10 patients did not meet inclusion/exclusion criteria; * 3 did not meet Day 1 check-in criteria; * 3 withdrew consent; * 3 were not entered because the study was closed to enrolment; * 4 patients were for other reasons

Participant milestones

Participant milestones
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg Participants with a diagnosis of opioid use disorder (OUD) stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
Overall Study STARTED	26
Overall Study Treated With SUBLOCADE	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg Participants with a diagnosis of opioid use disorder (OUD) stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	2
Overall Study Did not meet Day 1 check-in criteria	1

Baseline Characteristics

SUBLOCADE Rapid Initiation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg n=24 Participants Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
Age, Continuous	40.0 years STANDARD_DEVIATION 13.45 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=5 Participants
Race/Ethnicity, Customized White	13 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Age Group >=18 to <30 years	7 Participants n=5 Participants
Age Group >=30 to <45 years	8 Participants n=5 Participants
Age Group >=45 to < 60 years	6 Participants n=5 Participants
Age Group >=60 to < 65 years	3 Participants n=5 Participants
Age Group >= 65 years	0 Participants n=5 Participants
Ethnicity Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity Not Reported	2 Participants n=5 Participants
Screening Body Mass Index (BMI)	22.60 kg/m^2 STANDARD_DEVIATION 4.058 • n=5 Participants
Screening BMI Group 0 to <18.5 (underweight)	2 Participants n=5 Participants
Screening BMI Group >=18.5 and <25 (normal)	18 Participants n=5 Participants
Screening BMI Group >=25 and <30 (overweight)	1 Participants n=5 Participants
Screening BMI Group >=30 (obesity)	3 Participants n=5 Participants
Tobacco Use Never	2 Participants n=5 Participants
Tobacco Use Current	22 Participants n=5 Participants
Caffeine Use Never	2 Participants n=5 Participants
Caffeine Use Current	22 Participants n=5 Participants
Clinical Opiate Withdrawal Scale (COWS) Total Score at Screening	4.7 units on a scale STANDARD_DEVIATION 4.63 • n=5 Participants
Opioid Craving Visual Analog Scale (OC-VAS) at Screening	58.3 units on a scale STANDARD_DEVIATION 23.97 • n=5 Participants
Urine Drug Screen (UDS) for Opioids at Screening Positive	18 Participants n=5 Participants
Urine Drug Screen (UDS) for Opioids at Screening Negative	6 Participants n=5 Participants
Opioid Drug Use History - Lifetime Use	13.88 years STANDARD_DEVIATION 13.542 • n=5 Participants
Opioid Drug Use History - Last 30 Days Use	28.88 days STANDARD_DEVIATION 3.837 • n=5 Participants
Opioid Drug Use History - Participants Use Intravenously in Last 30 Days	6 Participants n=5 Participants
Day 1 Urine Drug Screen: Participants with Positive Opioid Tests Morphine	5 Participants n=5 Participants
Day 1 Urine Drug Screen: Participants with Positive Opioid Tests Methadone	1 Participants n=5 Participants
Day 1 Urine Drug Screen: Participants with Positive Opioid Tests Fentanyl	17 Participants n=5 Participants
Day 1 Urine Drug Screen: Participants with Positive Opioid Tests Oxycodone	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1: Pre-SUBLOCADE evaluation taken after TM buprenorphine treatment and prior to injection: SUBLOCADE evaluation taken within one hour of SUBLOCADE injection

Population: Full analysis set (FAS): Participants who receive a SUBLOCADE injection and have data for \>=1 COWS assessment at the Pre-SUBLOCADE timepoint just before the SUBLOCADE injection and a COWS assessment within one hour after the SUBLOCADE injection. One participant did not have a COWS score at one hour so is not included.

Outcome measures

Outcome measures
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg n=23 Participants Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
Participants Who Experienced Any Precipitated Withdrawal Within One Hour After SUBLOCADE Administration	1 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 28

Population: The safety population was used for the safety analysis, and consisted of all participants who received at least 1 dose of SUBLOCADE

A TEAE was an AE that started after the administration of TM buprenorphine for induction on Day 1. TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition. AEs of special interest include SUBOCADE depot removal, occurrences of alanine aminotransferase (ALT) \>3\*upper limit of normal (ULN) and bilirubin \>2\*ULN.

Outcome measures

Outcome measures
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg n=24 Participants Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
Participants With Treatment-Emergent Adverse Events (TEAE) Any TEAE	20 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Study Drug-related TEAE	5 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Serious TEAE	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Related and Serious TEAE	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) TEAE leading to discontinuation of drug	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) TEAE leading to interruption of drug	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Serious TEAEs - interruption of drug	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) AE of Special Interest	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Severe TEAE	5 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) TEAE leading to death	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Serious TEAEs - discontinuation of drug	0 Participants

SECONDARY outcome

Timeframe: Day 1 SUBLOCADE injection up to 48 hours later

Population: The safety population was used for the safety analysis, and consisted of all participants who received at least 1 dose of SUBLOCADE

Outcome measures

Outcome measures
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg n=24 Participants Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection Study Drug-related TEAE	4 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection Serious TEAE	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection Related and Serious TEAE	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection Severe TEAE	5 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection TEAE leading to death	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection TEAE leading to discontinuation of drug	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection TEAE leading to interruption of drug	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection Serious TEAEs - discontinuation of drug	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection Serious TEAEs - interruption of drug	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection AE of Special Interest	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection Any TEAE	19 Participants

SECONDARY outcome

Timeframe: Day 1: Pre-SUBLOCADE evaluation taken after TM buprenorphine treatment and prior to injection: SUBLOCADE evaluations taken 1, 6, 12, 24 and 48 hours after SUBLOCADE injection.

Population: Full analysis set (FAS) of participants 'at risk' at the start of the time interval. A participant was at risk if they had a pre-SUBLOCADE COWs assessment and COWS assessments at the current and all prior key timepoints and did not have the event in a previous timepoint. One participant did not have a COWS score at one hour so is not included.

COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Cumulative number of participants in key timepoints who had a COWS total score increase of ≥6 points from the pre-SUBLOCADE value.

Outcome measures

Outcome measures
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg n=23 Participants Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
Cumulative Number of Participants Who Experienced a >=6 Point Clinical Opiate Withdrawal Scale (COWS) Total Score Increase After SUBLOCADE Administration From the Pre-SUBLOCADE Value at Key Timepoints >12 to 24 hours	2 Participants
Cumulative Number of Participants Who Experienced a >=6 Point Clinical Opiate Withdrawal Scale (COWS) Total Score Increase After SUBLOCADE Administration From the Pre-SUBLOCADE Value at Key Timepoints >0 to 1 hour	1 Participants
Cumulative Number of Participants Who Experienced a >=6 Point Clinical Opiate Withdrawal Scale (COWS) Total Score Increase After SUBLOCADE Administration From the Pre-SUBLOCADE Value at Key Timepoints >24 to 48 hours	2 Participants
Cumulative Number of Participants Who Experienced a >=6 Point Clinical Opiate Withdrawal Scale (COWS) Total Score Increase After SUBLOCADE Administration From the Pre-SUBLOCADE Value at Key Timepoints > 1 to 6 hours	2 Participants
Cumulative Number of Participants Who Experienced a >=6 Point Clinical Opiate Withdrawal Scale (COWS) Total Score Increase After SUBLOCADE Administration From the Pre-SUBLOCADE Value at Key Timepoints >6 to 12 hours	2 Participants

SECONDARY outcome

Timeframe: SUBLOCADE injection on Day 1 through 1, 6, 12, 24 and 48 hours after SUBLOCADE injection

Population: Full analysis set. Participants were included in a given interval if they had a pre-SUBLOCADE COWS assessment and a COWS assessment at the terminal timepoint for the interval.

The area under the curve (AUC) for COWS total score from the pre-SUBLOCADE value to a later time point were calculated using the linear trapezoidal method. For each analysis time interval (AUC0-1hr, AUC0-6hrs, AUC0-12hrs, AUC0-24hrs, AUC0-48hrs) the AUC value was normalized across participants for the actual duration (in hours) of the time interval. The normalized AUC for COWS can be interpreted as the averaged AUC per hour or the averaged COWS over a time interval, as if the COWS was measured hourly during that time interval. Participants were included in a given interval if they had a pre-SUBLOCADE COWS assessment and a COWS assessment at the terminal timepoint for the interval.

Outcome measures

Outcome measures
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg n=24 Participants Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
COWS Total Score Normalized Area Under the Curve (AUC) Through Key Timepoints Post SUBLOCADE Injection Through 1 hour post SUBLOCADE	11.91 hours*units on a scale Standard Deviation 3.700
COWS Total Score Normalized Area Under the Curve (AUC) Through Key Timepoints Post SUBLOCADE Injection Through 6 hours post SUBLOCADE	9.27 hours*units on a scale Standard Deviation 3.939
COWS Total Score Normalized Area Under the Curve (AUC) Through Key Timepoints Post SUBLOCADE Injection Through 12 hours post SUBLOCADE	7.91 hours*units on a scale Standard Deviation 3.772
COWS Total Score Normalized Area Under the Curve (AUC) Through Key Timepoints Post SUBLOCADE Injection Through 24 hours post SUBLOCADE	6.59 hours*units on a scale Standard Deviation 3.021
COWS Total Score Normalized Area Under the Curve (AUC) Through Key Timepoints Post SUBLOCADE Injection Through 48 hours post SUBLOCADE	5.03 hours*units on a scale Standard Deviation 2.566

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: Full analysis set of participants with data at each timepoint.

Outcome measures

Outcome measures
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg n=24 Participants Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
Total Score on COWS At Timepoints During the Treatment Period Day 1 Check-in	12.5 units on a scale Standard Deviation 3.74
Total Score on COWS At Timepoints During the Treatment Period Pre TM Buprenephrine	14.6 units on a scale Standard Deviation 4.13
Total Score on COWS At Timepoints During the Treatment Period Pre-SUBLOCADE	12.6 units on a scale Standard Deviation 4.05
Total Score on COWS At Timepoints During the Treatment Period 1 hour post-SUBLOCADE dose	11.1 units on a scale Standard Deviation 4.51
Total Score on COWS At Timepoints During the Treatment Period 2 hours post-SUBLOCADE dose	10.1 units on a scale Standard Deviation 4.99
Total Score on COWS At Timepoints During the Treatment Period 3 hours post-SUBLOCADE dose	9.1 units on a scale Standard Deviation 5.32
Total Score on COWS At Timepoints During the Treatment Period 4 hours post-SUBLOCADE dose	8.0 units on a scale Standard Deviation 3.93
Total Score on COWS At Timepoints During the Treatment Period 6 hours post-SUBLOCADE dose	6.9 units on a scale Standard Deviation 4.06
Total Score on COWS At Timepoints During the Treatment Period 8 hours post-SUBLOCADE dose	6.6 units on a scale Standard Deviation 3.83
Total Score on COWS At Timepoints During the Treatment Period 12 hours post-SUBLOCADE dose	6.6 units on a scale Standard Deviation 3.69
Total Score on COWS At Timepoints During the Treatment Period 16 hours post-SUBLOCADE dose	6.0 units on a scale Standard Deviation 2.65
Total Score on COWS At Timepoints During the Treatment Period 20 hours post-SUBLOCADE dose	5.0 units on a scale Standard Deviation 2.90
Total Score on COWS At Timepoints During the Treatment Period 24 hours post-SUBLOCADE dose	4.2 units on a scale Standard Deviation 3.16
Total Score on COWS At Timepoints During the Treatment Period 30 hours post-SUBLOCADE dose	3.9 units on a scale Standard Deviation 3.00
Total Score on COWS At Timepoints During the Treatment Period 36 hours post-SUBLOCADE dose	3.5 units on a scale Standard Deviation 2.65
Total Score on COWS At Timepoints During the Treatment Period 48 hours post-SUBLOCADE dose	2.8 units on a scale Standard Deviation 2.54
Total Score on COWS At Timepoints During the Treatment Period Day 8	1.9 units on a scale Standard Deviation 1.64
Total Score on COWS At Timepoints During the Treatment Period Day 15	2.0 units on a scale Standard Deviation 1.99
Total Score on COWS At Timepoints During the Treatment Period Day 22	2.0 units on a scale Standard Deviation 2.58
Total Score on COWS At Timepoints During the Treatment Period End of Treatment Day 29	1.8 units on a scale Standard Deviation 2.12

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: Full analysis set of participants with data at each timepoint.

Participants indicated their level of craving for opioids by marking a 100mm visual analogue scale where 0 = no craving and 100 = maximal craving.

Outcome measures

Outcome measures
Measure	TM Buprenorphine Followed by SUBLOCADE 300 mg n=24 Participants Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period Day 1 Check-in	66.0 units on a scale Standard Deviation 22.03
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period Pre TM Buprenephrine	65.0 units on a scale Standard Deviation 31.06
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 2 hours post-SUBLOCADE dose	52.8 units on a scale Standard Deviation 29.99
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 3 hours post-SUBLOCADE dose	53.9 units on a scale Standard Deviation 30.22
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 4 hours post-SUBLOCADE dose	44.5 units on a scale Standard Deviation 29.75
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 6 hours post-SUBLOCADE dose	42.6 units on a scale Standard Deviation 26.98
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 8 hours post-SUBLOCADE dose	43.1 units on a scale Standard Deviation 27.20
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 12 hours post-SUBLOCADE dose	39.3 units on a scale Standard Deviation 31.19
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 16 hours post-SUBLOCADE dose	29.7 units on a scale Standard Deviation 38.48
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 20 hours post-SUBLOCADE dose	33.5 units on a scale Standard Deviation 20.79
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 24 hours post-SUBLOCADE dose	27.3 units on a scale Standard Deviation 20.77
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 30 hours post-SUBLOCADE dose	16.7 units on a scale Standard Deviation 12.37
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 36 hours post-SUBLOCADE dose	13.8 units on a scale Standard Deviation 13.74
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 48 hours post-SUBLOCADE dose	12.1 units on a scale Standard Deviation 12.09
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period End of Treatment Day 29	7.3 units on a scale Standard Deviation 9.24
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period Pre-SUBLOCADE	57.0 units on a scale Standard Deviation 28.91
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period 1 hour post-SUBLOCADE dose	56.5 units on a scale Standard Deviation 26.52
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period Day 8	7.6 units on a scale Standard Deviation 11.00
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period Day 15	6.4 units on a scale Standard Deviation 9.54
Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period Day 22	13.1 units on a scale Standard Deviation 20.32

Adverse Events

Induction Phase

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Safety Population (Post -SUBLOCADE)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Induction Phase n=26 participants at risk Treatment-emergent adverse events (TEAEs) where the start date/time of the event is on or after the date/time of the administration of transmucosal (TM) buprenorphine (BUP) for induction but prior to the date/time of the SUBLOCADE injection.	Safety Population (Post -SUBLOCADE) n=24 participants at risk Treatment-emergent adverse events (TEAEs) where the start date/time of the event is post-SUBLOCADE injection.
Psychiatric disorders Irritability	0.00% 0/26 • Day 1 to Day 29	50.0% 12/24 • Day 1 to Day 29
Psychiatric disorders Anxiety	7.7% 2/26 • Day 1 to Day 29	37.5% 9/24 • Day 1 to Day 29
Psychiatric disorders Insomnia	0.00% 0/26 • Day 1 to Day 29	25.0% 6/24 • Day 1 to Day 29
Psychiatric disorders Agitation	0.00% 0/26 • Day 1 to Day 29	4.2% 1/24 • Day 1 to Day 29
Gastrointestinal disorders Nausea	0.00% 0/26 • Day 1 to Day 29	41.7% 10/24 • Day 1 to Day 29
Gastrointestinal disorders Diarrhoea	0.00% 0/26 • Day 1 to Day 29	16.7% 4/24 • Day 1 to Day 29
Gastrointestinal disorders Vomiting	3.8% 1/26 • Day 1 to Day 29	12.5% 3/24 • Day 1 to Day 29
General disorders Pain	7.7% 2/26 • Day 1 to Day 29	33.3% 8/24 • Day 1 to Day 29
General disorders Chills	0.00% 0/26 • Day 1 to Day 29	12.5% 3/24 • Day 1 to Day 29
General disorders Injection site bruising	0.00% 0/26 • Day 1 to Day 29	12.5% 3/24 • Day 1 to Day 29
General disorders Injection site erythema	0.00% 0/26 • Day 1 to Day 29	4.2% 1/24 • Day 1 to Day 29
General disorders Drug withdrawal syndrome	3.8% 1/26 • Day 1 to Day 29	0.00% 0/24 • Day 1 to Day 29
Infections and infestations Gastroenteritis viral	0.00% 0/26 • Day 1 to Day 29	4.2% 1/24 • Day 1 to Day 29
Infections and infestations Herpes zoster	0.00% 0/26 • Day 1 to Day 29	4.2% 1/24 • Day 1 to Day 29
Infections and infestations Infusion site cellulitis	0.00% 0/26 • Day 1 to Day 29	4.2% 1/24 • Day 1 to Day 29
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/26 • Day 1 to Day 29	4.2% 1/24 • Day 1 to Day 29
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/26 • Day 1 to Day 29	4.2% 1/24 • Day 1 to Day 29
Nervous system disorders Headache	0.00% 0/26 • Day 1 to Day 29	4.2% 1/24 • Day 1 to Day 29

Additional Information

Global Director, Clinical Development

Indivior, Inc

Phone: 804-379-1090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multicenter publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.
Publication restrictions are in place

Restriction type: OTHER