Evaluation of Long-term Buprenorphine Plasma Exposure
Status: | Enrolling by invitation |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 3/8/2019 |
Start Date: | February 19, 2019 |
End Date: | December 2019 |
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
To characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE
treatment. There are no interventions planned.
treatment. There are no interventions planned.
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.
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.
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 SC injections of SUBLOCADE
- Within 12 to 30 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 enrolment 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
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