Evaluation of Long-term Buprenorphine Plasma Exposure

Completed

Conditions studied: Opioid-use Disorder

In brief

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.

Key facts

Study ID

NCT03752528

Run by

Indivior Inc.

People needed

53

Starts

2019-02-19

Expected to finish

2019-07-18

Last updated by the study team

2020-08-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Pathway Healthcare — Hamilton, Alabama, United States
• Meridian Research — Tampa, Florida, United States
• Phoenix Medical Research — Prairie Village, Kansas, United States
• Adams Clinical — Watertown, Massachusetts, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Neurobehavioral Clinical Research — North Canton, Ohio, United States
• Pahl Research — Oklahoma City, Oklahoma, United States
• SP Research — Oklahoma City, Oklahoma, United States
• CODA — Portland, Oregon, United States
• Clinical Research Associates of Central PA, LLC — Altoona, Pennsylvania, United States
• Pillar Research — Richardson, Texas, United States

Full record on ClinicalTrials.gov

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