Evaluation of Long-term Buprenorphine Plasma Exposure

An observational study of Opioid-use Disorder, run by Indivior Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Opioid-use Disorder
What is being tested?: Blood sample collection and Urine sample collection
How many people: 53 participants
Where: 11 sitesUnited States
Study dates: 19 Feb 2019to 18 Jul 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Clinical Research Associates of Central PA, LLC
Altoona, Pennsylvania, 16602
Hassman Research Institute
Berlin, New Jersey, 08009
Pathway Healthcare
Hamilton, Alabama, 35570
Neurobehavioral Clinical Research
North Canton, Ohio, 44720
Pahl Research
Oklahoma City, Oklahoma, 73112
SP Research
Oklahoma City, Oklahoma, 73112
CODA
Portland, Oregon, 97232
Phoenix Medical Research
Prairie Village, Kansas, 66208
Pillar Research
Richardson, Texas, 75080
Meridian Research
Tampa, Florida, 33606
Adams Clinical
Watertown, Massachusetts, 02472

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Opioid-use Disorder
Being tested: Blood sample collection, Urine sample collection
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood sample collectionDiagnostic test
Determination of buprenorphine and norbuprenorphine plasma concentrations
Urine sample collectionDiagnostic test
Urine sample for determination of free buprenorphine and free norbuprenorphine concentrations, qualitative UDS for opioids, quantitative UDS for buprenorphine, norbuprenorphine and naloxone, and determination of creatinine concentration

Study groups in NCT03752528
Study group	Role	What they receive
Part A Cohort		Representative data set of participants from study RB-US-13-0003 or both studies RB-US-13-0003 and INDV-6000-301 who received at least 2 doses of SUBLOCADE 12-36 months prior. Part A consists of a single visit (Visit 1) for both screening and collection of blood and urine samples. Receives: Diagnostic Test: Blood sample collection; Diagnostic Test: Urine sample collection
Part B Cohort		Part A participants with a quantifiable (i.e. positive) result for buprenorphine and/or norbuprenorphine and a non-quantifiable (i.e. negative) result for naloxone continue in the study for two additional visits (Visits 2 and 3) which are conducted approximately 30 days apart during which blood and urine samples are collected. Receives: Diagnostic Test: Blood sample collection; Diagnostic Test: Urine sample collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B
The qualitative UDS (immunoassay) is the primary test used for the initial screening for opioids in patients in clinical practice. It provides only a qualitative assessment of buprenorphine exposure (i.e., positive or negative) with a low limit of quantification (LLOQ) of 5 ng/mL. The qualitative UDS is reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3).
Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Measured: Days 1, 30, 60
Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B
The quantitative UDS measures both buprenorphine and its glucuronide, or both norbuprenorphine and its glucuronide, with an LLOQ of 2 ng/mL. It is typically used by physicians for the confirmation of a positive result on the qualitative UDS.
Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3).
For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is "Not Available"
Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Measured: Days 1, 30, 60
Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B
The urine free drug test only measures the "free" buprenorphine and "free" norbuprenorphine (without their glucuronides) with an LLOQ of 0.02 ng/mL.
Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3).
For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is "Not Available"
Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Measured: Days 1, 30, 60
Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B
A sensitive liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was used to assess the plasma exposure to buprenorphine and norbuprenorphine, its major metabolite. The LLOQ was 0.02 ng/mL for both analytes, which is much lower than the LLOQ of plasma/serum assays conducted by diagnostic laboratories.
Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3).
For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is "Not Available"
Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Measured: Days 1, 30, 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 201918 Jul 2019

First posted26 Nov 2018
Study start19 Feb 2019
Primary completion18 Jul 2019
Study completion18 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03752528
Sponsor's protocol ID: INDV-6000-402
Status last verified: Aug 2020
First submitted: 21 Nov 2018
Last updated: 21 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingPhase 2
A Study of Brenipatide in Participants With Opioid Use Disorder
Opioid Use Disorder
RecruitingPhase 1
Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use
Opioid Use, Substance Use Disorders
Recruiting
Using Facebook to Support Opioid Recovery Among American Indian Women
Opioid Use Disorder
Active, not recruiting
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Chronic Pain, Opioid Use Disorder

All Opioid-use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03752528
Acronym / sponsor ID: INDV-6000-402
Conditions: Opioid-use Disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Indivior Inc.Industry (pharma, biotech, devices)
Study start: 19 Feb 2019 (actual)
Primary completion: 18 Jul 2019 (actual)
Study completion: 18 Jul 2019 (actual)
First posted: 26 Nov 2018 (actual)
Results: Posted 3 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

There are two parts to the study:

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Part A Cohort	–	Diagnostic Test: Blood sample collection, Diagnostic Test: Urine sample collectionRepresentative data set of participants from study RB-US-13-0003 or both studies RB-US-13-0003 and INDV-6000-301 who received at least 2 doses of SUBLOCADE 12-36 months prior. Part A consists of a single visit (Visit 1) for both screening and collection of blood and urine samples.
Part B Cohort	–	Diagnostic Test: Blood sample collection, Diagnostic Test: Urine sample collectionPart A participants with a quantifiable (i.e. positive) result for buprenorphine and/or norbuprenorphine and a non-quantifiable (i.e. negative) result for naloxone continue in the study for two additional visits (Visits 2 and 3) which are conducted approximately 30 days apart during which blood and urine samples are collected.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood sample collectionDetermination of buprenorphine and norbuprenorphine plasma concentrations	Diagnostic test	Part A Cohort, Part B Cohort
Urine sample collectionUrine sample for determination of free buprenorphine and free norbuprenorphine concentrations, qualitative UDS for opioids, quantitative UDS for buprenorphine, norbuprenorphine and naloxone, and determination of creatinine concentration	Diagnostic test	Part A Cohort, Part B Cohort

Primary outcome

Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B
Time frame: Days 1, 30, 60
The qualitative UDS (immunoassay) is the primary test used for the initial screening for opioids in patients in clinical practice. It provides only a qualitative assessment of buprenorphine exposure (i.e., positive or negative) with a low limit of quantification (LLOQ) of 5 ng/mL. The qualitative UDS is reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B
Time frame: Days 1, 30, 60
The quantitative UDS measures both buprenorphine and its glucuronide, or both norbuprenorphine and its glucuronide, with an LLOQ of 2 ng/mL. It is typically used by physicians for the confirmation of a positive result on the qualitative UDS. Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is "Not Available" Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B
Time frame: Days 1, 30, 60
The urine free drug test only measures the "free" buprenorphine and "free" norbuprenorphine (without their glucuronides) with an LLOQ of 0.02 ng/mL. Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is "Not Available" Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B
Time frame: Days 1, 30, 60
A sensitive liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was used to assess the plasma exposure to buprenorphine and norbuprenorphine, its major metabolite. The LLOQ was 0.02 ng/mL for both analytes, which is much lower than the LLOQ of plasma/serum assays conducted by diagnostic laboratories. Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is "Not Available" Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.

Results and safety

Results posted to the registry on 3 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	53	51

Primary outcome: Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B

Time frame: Days 1, 30, 60. Count of participants. Unit: Participants

Measure	Part A Cohort: Visit 1 n = 49	Part B Cohort: Visit 1 n = 24	Part B Cohort: Visit 2 n = 23	Part B Cohort: Visit 3 n = 20
Positive	27	19	16	15
Negative	22	5	7	5

Population analysed: Full analysis set includes participants who have at least one measure of buprenorphine or norbuprenorphine concentration in plasma or in urine in Part A. Four participants who tested positive for naloxone in urine were excluded from summary results. One participant was terminated from the study prior to Part B, Visit 2.

Primary outcome: Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B

Time frame: Days 1, 30, 60. Count of participants. Unit: Participants

Measure	Part A Cohort: Visit 1 n = 49	Part B Cohort: Visit 1 n = 24	Part B Cohort: Visit 2 n = 23	Part B Cohort: Visit 3 n = 20
Buprenorphine - Positive	31	23	19	17
Buprenorphine - Negative	18	1	4	3
Buprenorphine - Not Available	0	0	0	0
Norbuprenorphine - Positive	29	21	19	17
Norbuprenorphine - Negative	19	2	4	3
Norbuprenorphine- Not Available	1	1	0	0
Bup + Nor - Positive	32	24	20	18
Bup + Nor - Negative	17	0	3	2

Primary outcome: Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B

Time frame: Days 1, 30, 60. Count of participants. Unit: Participants

Measure	Part A Cohort: Visit 1 n = 49	Part B Cohort: Visit 1 n = 24	Part B Cohort: Visit 2 n = 23	Part B Cohort: Visit 3 n = 20
Buprenorphine - Positive	30	19	17	17
Buprenorphine - Negative	19	5	5	3
Buprenorphine - Not Available	0	0	1	0
Norbuprenorphine - Positive	46	24	21	20
Norbuprenorphine - Negative	3	0	1	0
Norbuprenorphine- Not Available	0	0	1	0
Bup + Nor - Positive	46	24	21	20
Bup + Nor - Negative	3	0	1	0

Primary outcome: Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B

Time frame: Days 1, 30, 60. Count of participants. Unit: Participants

Measure	Part A Cohort: Visit 1 n = 49	Part B Cohort: Visit 1 n = 24	Part B Cohort: Visit 2 n = 23	Part B Cohort: Visit 3 n = 20
Buprenorphine - Positive	32	20	18	16
Buprenorphine - Negative	15	3	4	3
Buprenorphine - Not Available	2	1	1	1
Norbuprenorphine - Positive	20	12	11	11
Norbuprenorphine - Negative	27	11	11	8
Norbuprenorphine- Not Available	2	1	1	1
Bup + Nor - Positive	32	20	18	16
Bup + Nor - Negative	15	3	4	3

Adverse events

Time frame: Day 1 to Day 60. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 53 (0%)	0 of 53 (0%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid-use Disorder, run by Indivior Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B (time frame: Days 1, 30, 60). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03752528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.