Clinical Data Subjects were initially inducted onto SUBOXONE® (buprenorphine/naloxone) sublingual film for 3 days according to the SUBOXONE® sublingual film prescribing information in order to prevent withdrawal from opiates and to ensure lack of allergy to buprenorphine. The subjects then completed a 4- to 11-day SUBOXONE® sublingual film dose adjustment (SUBOXONE® doses ranging from 8 mg to 24 mg). Once subjects met the randomization criteria of no significant opioid craving (≤20 mm on the Opioid Craving Visual Analog Scale [VAS]) or withdrawal (a score of ≤ 12 on the Clinical Opiate Withdrawal Scale [COWS]) after at least 7 days of SUBOXONE® sublingual film therapy, they were randomized to either 1 of 2 dose regimens of RBP-6000 or placebo of the equivalent volume in 6 SC injections separated by 28 days. Subjects randomized to receive dose regimen #1 of RBP-6000 received 1 injection of 300 mg RBP- 6000 on Day 1 and then every 28 (±2) days thereafter. Subjects randomized to receive dose regimen #2 of RBP-6000 received 1 injection of 300 mg RBP-6000 on Day 1 and Day 29 (±2 days), which were then followed by 4 injections (once every 28 ± 2 days) of 100 mg of RBP-6000. RBP-6000 was generally well tolerated in this study. Available safety findings suggest that 2.8% of subjects on RBP-6000 (both dosage regimens combined) experienced a serious treatment-emergent adverse event (TEAE) compared with 5.1% of subjects on placebo. There were no related serious TEAEs across groups. 7.2% of subjects on RBP-6000 (both dosage regimens combined) experienced a severe TEAE compared with 4.0% of subjects on placebo. 4.6% of subjects on RBP-6000 (both dosage regimens combined) discontinued treatment due to TEAEs compared with 2.0% of subjects on placebo.