Study: NCT03747341

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buprenorphine Injectable Solution - Part A
Description: Buprenorphine intravenous (IV) injection given as a primed-continuous infusion.~Low Dose: initial bolus (0.05 mg/70 kg) administered over 15 minutes and infusion continued (0.02 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.2 ng/ml.~High Dose: initial bolus (0.125 mg/70 kg) administered over 15 minutes and infusion continued (0.05 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.5 ng/ml.~Administration of buprenorphine was flexible and infusion rates were selected to target approximately 25 to 50% respiratory depression.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buprenorphine Injectable Solution - Part A
Description: Buprenorphine intravenous (IV) injection given as a primed-continuous infusion.~Low Dose: initial bolus (0.05 mg/70 kg) administered over 15 minutes and infusion continued (0.02 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.2 ng/ml.~High Dose: initial bolus (0.125 mg/70 kg) administered over 15 minutes and infusion continued (0.05 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.5 ng/ml.~Administration of buprenorphine was flexible and infusion rates were selected to target approximately 25 to 50% respiratory depression.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buprenorphine Injectable Solution - Part A
Description: Buprenorphine intravenous (IV) injection given as a primed-continuous infusion.~Low Dose: initial bolus (0.05 mg/70 kg) administered over 15 minutes and infusion continued (0.02 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.2 ng/ml.~High Dose: initial bolus (0.125 mg/70 kg) administered over 15 minutes and infusion continued (0.05 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.5 ng/ml.~Administration of buprenorphine was flexible and infusion rates were selected to target approximately 25 to 50% respiratory depression.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buprenorphine Injectable Solution - Part A
Description: Buprenorphine intravenous (IV) injection given as a primed-continuous infusion.~Low Dose: initial bolus (0.05 mg/70 kg) administered over 15 minutes and infusion continued (0.02 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.2 ng/ml.~High Dose: initial bolus (0.125 mg/70 kg) administered over 15 minutes and infusion continued (0.05 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.5 ng/ml.~Administration of buprenorphine was flexible and infusion rates were selected to target approximately 25 to 50% respiratory depression.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo - Parts A + B
Description: 0.9% normal saline for IV administration was used as placebo matching the buprenorphine formulation and administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo - Parts A + B
Description: 0.9% normal saline for IV administration was used as placebo matching the buprenorphine formulation and administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo - Parts A + B
Description: 0.9% normal saline for IV administration was used as placebo matching the buprenorphine formulation and administration.