Opioid Use DisorderPhase 1NCT02559973
Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder
A Phase 1 study testing RBP-6000 and SUBOXONE Sublingual Film in people with Opioid Use Disorder, run by Indivior Inc. at 1 site in United States.
Trial summary
This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- RBP-6000 and SUBOXONE Sublingual Film
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently meets DSM-5 criteria for moderate or severe opioid use disorder (OUD)
- Is seeking treatment for OUD
- Body mass index: ≥ 18.0 to ≤ 35.0 kg/m^2
- Females: Female individuals of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from Screening through at least 6 months after the last dose of Investigational Medicinal Product (IMP).
- Males: Male individuals with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the informed consent form through at least 6 months after the last dose of IMP. Male individuals must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
- Have a normal electrocardiogram (ECG) or ECG with no clinically significant findings in the opinion of the Investigator or medically qualified sub-investigator at Screening and through pre-dose on Day 1.
- Agree not to take any buprenorphine-containing products, other than those administered for the current study, throughout the duration of the study.
- Willing to adhere to study procedures and provide written informed consent prior to start of any study procedures.
Who cannot join
- Current diagnosis, other than OUD, requiring chronic opioid treatment.
- Pregnant or lactating females.
- Have an ECG demonstrating a corrected QT interval using Fridericia's calculation (QTcF) > 450 msec in males and QTcF > 470 msec in females upon admission to the residential facility or prior to administration of RBP-6000.
- Currently meet the criteria for diagnosis of moderate or severe substance use disorder, by DSM-5 criteria, for any substances other than opioids, and/or tobacco.
- Had a significant traumatic injury, major surgery, or open biopsy within the 4 weeks prior to signing the informed consent form.
- Used buprenorphine-containing products within the 14 days prior to signing the informed consent form.
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- Have a history of suicidal ideation within the 30 days prior to signing the informed consent form or prior to study drug administration
- Have a history or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine, naloxone, methadone, or the ATRIGEL Delivery System.
- Individuals who have a positive urine drug screen (UDS) prior to admission to the residential facility for barbiturates, benzodiazepines, buprenorphine, or methadone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince & Associates Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Single-Center, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine (RBP-6000) Using Poly (DL-lactide-co-glycolide) Polymer of Two Different Molecular Weights (Low and High Molecular Weights as Test Treatments) in Comparison to Intermediate Molecular Weight (Reference Treatment) in Treatment-Seeking Subjects With Opioid Use Disorder
This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.
- Conditions
- Opioid Use Disorder
- Being tested
- RBP-6000, SUBOXONE Sublingual Film
- Keywords
- Buprenorphine, opioid use disorder
- 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.
RBP-6000Drug
Also called buprenorphine
RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.
SUBOXONE Sublingual FilmDrug
Also called buprenorphine HCl and naloxone HCl dihydrate
Subjects will be dose-stabilized on SUBOXONE sublingual film prior to administration of RBP-6000. SUBOXONE sublingual film will be administered beginning after the subject is experiencing signs and symptoms of withdrawal on Day -8 and continue until Day -1.
| Study group | Role | What they receive |
|---|---|---|
| RBP-6000 - Light MW | Experimental | Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer. Receives: Drug: RBP-6000; Drug: SUBOXONE Sublingual Film |
| RBP-6000 - Heavy MW | Experimental | Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer. Receives: Drug: RBP-6000; Drug: SUBOXONE Sublingual Film |
| RBP-6000 - Intermediate MW | Active comparator | Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference). Receives: Drug: RBP-6000; Drug: SUBOXONE Sublingual Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
Relative bioavailability will be assessed using AUC0-28days.
Measured: Day 1 to Day 29
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
Relative bioavailability will also be assessed using Cmax
Measured: Day 1 to Day 57
Secondary outcomes (3)
Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Norbuprenorphine
Measured: Day 1 to Day 29
Maximum Observed Plasma Concentration (Cmax) of Norbuprenorphine
Measured: Day 1 to Day 57
Participants with Treatment-Emergent Adverse Events
Measured: Day 1 to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559973
- Sponsor's protocol ID
- RB-US-13-0006
- Status last verified
- Jan 2017
- First submitted
- 23 Sep 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine (RBP-6000) Using Poly (DL-lactide-co-glycolide) Polymer of Two Different Molecular Weights (Low and High Molecular Weights as Test Treatments) in Comparison to Intermediate Molecular Weight (Reference Treatment) in Treatment-Seeking Subjects With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT02559973
- Acronym / sponsor ID
- RB-US-13-0006
- Conditions
- Opioid Use Disorder
- Keywords
- Buprenorphine, opioid use disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RBP-6000 - Light MW | Experimental | Drug: RBP-6000, Drug: SUBOXONE Sublingual FilmSingle subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer. |
| RBP-6000 - Heavy MW | Experimental | Drug: RBP-6000, Drug: SUBOXONE Sublingual FilmSingle subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer. |
| RBP-6000 - Intermediate MW | Active comparator | Drug: RBP-6000, Drug: SUBOXONE Sublingual FilmSingle subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Currently meets DSM-5 criteria for moderate or severe opioid use disorder (OUD)
- Is seeking treatment for OUD
- Body mass index: ≥ 18.0 to ≤ 35.0 kg/m^2
- Females: Female individuals of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from Screening through at least 6 months after the last dose of Investigational Medicinal Product (IMP).
- Males: Male individuals with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the informed consent form through at least 6 months after the last dose of IMP. Male individuals must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
Key exclusion criteria (9 listed)
- Current diagnosis, other than OUD, requiring chronic opioid treatment.
- Pregnant or lactating females.
- Have an ECG demonstrating a corrected QT interval using Fridericia's calculation (QTcF) > 450 msec in males and QTcF > 470 msec in females upon admission to the residential facility or prior to administration of RBP-6000.
- Currently meet the criteria for diagnosis of moderate or severe substance use disorder, by DSM-5 criteria, for any substances other than opioids, and/or tobacco.
- Had a significant traumatic injury, major surgery, or open biopsy within the 4 weeks prior to signing the informed consent form.
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 |
|---|---|---|
| RBP-6000Also: buprenorphineRBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine. | Drug | RBP-6000 - Heavy MW, RBP-6000 - Intermediate MW, RBP-6000 - Light MW |
| SUBOXONE Sublingual FilmAlso: buprenorphine HCl and naloxone HCl dihydrateSubjects will be dose-stabilized on SUBOXONE sublingual film prior to administration of RBP-6000. SUBOXONE sublingual film will be administered beginning after the subject is experiencing signs and symptoms of withdrawal on Day -8 and continue until Day -1. | Drug | RBP-6000 - Heavy MW, RBP-6000 - Intermediate MW, RBP-6000 - Light MW |
Primary outcome
Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
Time frame: Day 1 to Day 29
Relative bioavailability will be assessed using AUC0-28days.
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
Time frame: Day 1 to Day 57
Relative bioavailability will also be assessed using Cmax
3 secondary outcomes
Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Norbuprenorphine
Time frame: Day 1 to Day 29
Maximum Observed Plasma Concentration (Cmax) of Norbuprenorphine
Time frame: Day 1 to Day 57
Participants with Treatment-Emergent Adverse Events
Time frame: Day 1 to Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RBP-6000 and SUBOXONE Sublingual Film in people with Opioid Use Disorder, run by Indivior Inc. at 1 site 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 8 inclusion and 9 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine (time frame: Day 1 to Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2017.