Clinical trial NCT03752528: Evaluation of Long-term Buprenorphine Plasma Exposure
Official title: Evaluation of Long-term Buprenorphine Plasma Exposure in Subjects Who Received at Least 2 Subcutaneous (SC) Injections of Extended-release Buprenorphine (SUBLOCADE™) in Phase III Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-26
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who participated in either of the studies listed above and who received their last SUBLOCADE injection within 12 to 30 months of the Screening visit. A maximum of 30 subjects may continue to Part B and will return for 2 additional visits 30 days apart.

Brief summary: The study objective is to characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE treatment. There are no interventions planned.

This multicentre investigation will enroll participants from Study RB-US-13-0003 (NCT02510014) or both Studies RB-US-13-0003 and INDV-6000-301 (NCT02896296) and who received at least 2 subcutaneous (SC) injections of SUBLOCADE.

There are two parts to the study:

Part A consists of a single visit during which urine samples are collected to measure free buprenorphine and free norbuprenorphine concentrations; qualitative urine drug samples (UDS) for opioids, including buprenorphine; quantitative UDS for buprenorphine, norbuprenorphine and naloxone; and determination of creatinine concentration. Blood samples are collected for the determination of buprenorphine and norbuprenorphine plasma concentrations.

Results on the quantitative UDS performed in Part A determine enrollment in Part B: participants who provide a quantifiable (i.e., positive) result for buprenorphine and/or norbuprenorphine and a non-quantifiable (i.e., negative) result for naloxone meet continuation criteria to move on to Part B if Part B is still open to enrolment. Part B consists of two visits 30 days apart in which the same tests are run as were done in Part A.

Detailed description: Data indicate that after discontinuing SUBLOCADE patients may have detectable concentrations of buprenorphine in plasma and urine for 12 months or longer. Previous Phase II/III studies did not evaluate the pharmacokinetics (PK) of buprenorphine beyond 2 months after the last injection; this study will characterize the long-term plasma exposure starting at least 12 months after the last injection. The study will also assess relationships between plasma drug concentrations, free drug concentrations in urine and urine drug screen (UDS) results in order to provide refined guidance to patients and physicians with respect to long-term exposure to buprenorphine after stopping SUBLOCADE treatment.

Eligibility criteria: Inclusion Criteria:

* Participated in Study RB-US-13-0003 or both Studies RB-US-13-0003 and INDV-6000-301 and received at least 2 subcutaneous (SC) injections of SUBLOCADE
* Within 12 to 36 months post his or her last SUBLOCADE injection at the time of the Screening Visit
* Female individuals of childbearing potential must agree to have a pregnancy test administered prior to enrollment and throughout the study. Pregnancy does not prohibit participation
* Willing to adhere to study procedures and provide written informed consent prior to the start of any study procedures.

Exclusion Criteria:

* Received SUBLOCADE or any other long-acting buprenorphine product at any time after ending their participation in Study RB-US-13-0003 or Study INDV-6000-301
* Taken any buprenorphine (prescribed or illicit) within 3 weeks prior to the Screening visit (study Part A, Visit 1)

Primary outcomes:
measure: Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B
timeFrame: Days 1, 30, 60
measure: Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B
timeFrame: Days 1, 30, 60
measure: Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B
timeFrame: Days 1, 30, 60
measure: Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B
timeFrame: Days 1, 30, 60
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Pathway Healthcare
state: Alabama
city: Tampa
country: United States
facility: Meridian Research
state: Florida
city: Prairie Village
country: United States
facility: Phoenix Medical Research
state: Kansas
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: North Canton
country: United States
facility: Neurobehavioral Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Pahl Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: SP Research
state: Oklahoma
city: Portland
country: United States
facility: CODA
state: Oregon
city: Altoona
country: United States
facility: Clinical Research Associates of Central PA, LLC
state: Pennsylvania
city: Richardson
country: United States
facility: Pillar Research
state: Texas
Study officials:
References: