The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only. The hypothesis is that starting directly on OX219 works equally well (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on Day 3.
This was a prospective, randomized, multicenter, blinded, parallel-group, active-controlled, non-inferiority study conducted at 13 sites within the US. Eligible patients participated in 8 treatment visits on Days 1, 2, 3, 4, 8, 15, 22, and 29. Effectiveness of treatment was assessed as follows: * Retention in treatment at Day 3 * Clinician and patient assessments of opioid withdrawal symptoms * Assessment opioid cravings
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
313
Advanced-formulation buprenorphine/naloxone sublingual tablets
Buprenorphine sublingual tablets
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Haleyville, Alabama, United States
Unnamed facility
National City, California, United States
Retention in Treatment in the Per Protocol Population
Retention in treatment at Day 3 in the per protocol population (n=256) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3.
Time frame: Day 3
Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive
Least squares mean AUC in COWS total score on Days 1 to 3; COWS scores range from 0-48, with a lower score being more favorable
Time frame: Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1
AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive
Least squares mean AUC day 1 pre-dose through Day 3 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable
Time frame: Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1
AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive
Least squares mean AUC measurement in VAS score for cravings on Days 1 to 3; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")
Time frame: Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1
Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase)
Mean change from baseline in COWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); COWS scores range from 0-48, with a lower score being more favorable
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Unnamed facility
Oceanside, California, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Maitland, Florida, United States
Unnamed facility
North Miami, Florida, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Fall River, Massachusetts, United States
Unnamed facility
Flowood, Mississippi, United States
...and 4 more locations
Time frame: Predose on Days 4, 8, 15, 22, and 29
Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase)
Mean change from baseline in SOWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); SOWS scores range from 0-64, with a lower score being more favorable
Time frame: Pre-dose on Days 4, 8, 15, 22, and 29
Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase)
Mean change from baseline in VAS scores for cravings during the maintenance phase (Days 4, 8, 15, 22, and 29); the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")
Time frame: Pre-dose on Days 4, 8, 15, 22, and 29
Retention in Treatment in the Full Analysis Population
Retention in treatment at Day 3 in the full analysis population (N=310) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3.
Time frame: Day 3