Overview

This trial is active, not recruiting.

Condition opioid related disorder
Treatments rbp-6000, subutex
Phase phase 2
Sponsor Reckitt Benckiser Pharmaceuticals Inc.
Start date November 2012
End date September 2013
Trial size 90 participants
Trial identifier NCT01738503, RB-US-12-0005

Summary

This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics, efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine after induction and stabilization of treatment seeking subjects onto Subutex.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
rbp-6000 buprenorphine
18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and will be given on alternate sides of the participant's abdomen.
subutex Buprenorphine
Participants were inducted and stabilized (over a 14-day period) on SUBUTEX at doses of 8 mg, 12 mg, 14 mg, or 8-24 mg. Tablets are placed under the tongue until dissolved.
(Experimental)
Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
rbp-6000 buprenorphine
18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and will be given on alternate sides of the participant's abdomen.
subutex Buprenorphine
Participants were inducted and stabilized (over a 14-day period) on SUBUTEX at doses of 8 mg, 12 mg, 14 mg, or 8-24 mg. Tablets are placed under the tongue until dissolved.
(Experimental)
Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals. Participants who receive RBP-6000 containing 200 mg buprenorphine and reach Day 112 (and have received all 4 planned SC injections) will have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants will remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.
rbp-6000 buprenorphine
18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and will be given on alternate sides of the participant's abdomen.
subutex Buprenorphine
Participants were inducted and stabilized (over a 14-day period) on SUBUTEX at doses of 8 mg, 12 mg, 14 mg, or 8-24 mg. Tablets are placed under the tongue until dissolved.
(Experimental)
Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
rbp-6000 buprenorphine
18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and will be given on alternate sides of the participant's abdomen.
subutex Buprenorphine
Participants were inducted and stabilized (over a 14-day period) on SUBUTEX at doses of 8 mg, 12 mg, 14 mg, or 8-24 mg. Tablets are placed under the tongue until dissolved.
(Experimental)
Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals. Participants who receive RBP-6000 containing 200 mg buprenorphine and reach Day 112 (and have received all 4 planned SC injections) will have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants will remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.
rbp-6000 buprenorphine
18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and will be given on alternate sides of the participant's abdomen.
subutex Buprenorphine
Participants were inducted and stabilized (over a 14-day period) on SUBUTEX at doses of 8 mg, 12 mg, 14 mg, or 8-24 mg. Tablets are placed under the tongue until dissolved.
(Experimental)
Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.
rbp-6000 buprenorphine
18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and will be given on alternate sides of the participant's abdomen.
subutex Buprenorphine
Participants were inducted and stabilized (over a 14-day period) on SUBUTEX at doses of 8 mg, 12 mg, 14 mg, or 8-24 mg. Tablets are placed under the tongue until dissolved.

Primary Outcomes

Measure
Compare the steady state PK of buprenorphine and norbuprenorphine after SC doses of RBP-6000 relative to the corresponding SUBUTEX doses
time frame: Days -13 to -1 (Subutex treatment), Days 1-113 (RBP-6000 treatment)

Secondary Outcomes

Measure
Change from Baseline To Day 113 in the Clinical Opiate Withdrawal Scale (COWS)
time frame: Day 1 (pre-treatment), Day 113
Change from Baseline To Day 113 in the Subjective Opiate Withdrawal Scale (SOWS)
time frame: Day 1 (pre-treatment), Day 113
Change from Baseline To Day 113 in the Opioid Craving Visual Analog Scale (VAS)
time frame: Day 1 (pre-treatment), Day 113
Change from Baseline To Day 113 in the Clinical Global Impression Total Scores.
time frame: Day 1 (pre-treatment), Day 113
Change from Baseline To Day 113 in the Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: Day 1 (pre-treatment), Day 113

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Male and female subjects - Agree not to take any buprenorphine products other than those administered for the current study throughout participation in the study - Body mass index (BMI) of >18.0 to < 33.0 kg/m Exclusion Criteria: - Participants with a current diagnosis requiring chronic opioid treatment - Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF > 470 in females at screening - Abuse of buprenorphine or use of buprenorphine within 14 days of informed consent

Additional Information

Official title Open-Label, Multicenter, Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, Efficacy Markers, and Opioid Receptor Availability of Subcutaneous Injections of Depot Buprenorphine in Treatment Seeking Opioid-Dependent Subjects
Principal investigator Bradley D Vince, DO
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Reckitt Benckiser Pharmaceuticals Inc..