Opioid Use DisorderPhase 1NCT02765867
Single-dose, Study of RBP-6000 in Opioid Dependent Individuals
A Phase 1 study testing RBP-6000 in people with Opioid Use Disorder, run by Indivior Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an injection of RBP-6000. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- RBP-6000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to May 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- If female, must be surgically sterile or two-years post-menopausal and have a negative pregnancy test. Subjects should take reasonable precautions during the study to avoid pregnancy by agreeing to remain abstinent or to practice double-barrier forms of birth control from study screening through the last dose of study medication.
- Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for opioid dependence and who are seeking opioid-dependence treatment with methadone.
- Willing to cooperate with study procedures and provide written informed consent prior to start of any study procedures.
- Agree not to take any buprenorphine product (other than RBP-6000) throughout their participation in the study.
- Body mass index of ≥ 18 to ≤ 33 kg/m2.
- Total bilirubin < 2.5 mg/dL (51 μmol/L), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 × the upper limit of normal (ULN), serum creatinine < 2 x ULN, or international normalized ratio (INR) ≤ 2.0.
- Normal or no clinically significant ECG findings at screening
Who cannot join
- Require ongoing opioid therapy for pain or other chronic medical conditions.
- Additionally, individuals who answer "yes" to both of the following questions will be excluded from participation: A) Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than those kinds of pain today? B) If yes, has the pain persisted for three months or more?
- Currently dependent by DSM-IV-TR criteria on any substance other than opioids, caffeine, or nicotine.
- Positive urine screen at intake for barbiturates, benzodiazepines, buprenorphine, or methadone.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the study physician, would jeopardize the safety of the subject.
- Clinically significant abnormal finding on physical exam or in medical history; serology positive for HIV, hepatitis B or C [HBV antigen S positive, acute HBsAg and IgM antiHBc Chronic HCV antibody HCV, HCV RNA- acute: HCV RNA (PCR)].
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- History or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine, methadone, or the ATRIGEL Delivery System.
- Donation of more than 250 mL of blood or plasma, or participation in another clinical trial, within 30 days prior to signing of the informed consent document for this study.
- Currently (during past 30 days from the signing of the informed consent document) engaged in opioid agonist, partial agonist, or antagonist treatment, or require on-going prescription or over-the-counter medications that are clinically relevant P450 3A4 inducers or inhibitors [azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin),].
- Reporting taking buprenorphine within 30 days of screening.
- Significant traumatic injury, major surgery or open biopsy within the prior 4 weeks.
- Subjects who have been previously excluded from participation or previously enrolled into the study.
- Subjects who are unable, in the opinion of the Principal Investigator and/or the medically responsible physician, to comply fully with the study requirements.
- Subjects who have participated in another investigational product trial within 30 days of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scientific Clinical Research
Fort Lauderdale, Florida, 33301
About this study
Official title: A Single-Dose, Open-Label Study of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Individuals
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an injection of RBP-6000.
Read the detailed description
This is an open-label, single-center, first-in-human study, designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of a single subcutaneous (SC) injection of RBP-6000 in opioid dependent subjects. Enrollment will begin with 6 subjects, and additional subjects will not be enrolled until safety through Day 4 has been reviewed and analyzed. Subjects will remain in a residential unit through Day 30 post-injection and will continue with visits to the clinical unit until Day 85 or plasma buprenorphine levels are below 100 pg/mL, whichever comes later. The expected maximum duration of participation for each subject (including screening) is 120 days.
Safety will be assessed by adverse events, electrocardiograms, clinical laboratory assessments, local injection site tolerability and vital signs. PK will be assessed by measuring concentrations of buprenorphine and norbuprenorphine in plasma. The need for rescue medication will be assessed using clinical judgment along with information provided by the COWS scores.
- Conditions
- Opioid Use Disorder
- Being tested
- RBP-6000
- 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
A single injection of RBP-6000 containing a low dose of buprenorphine in the Atrigel delivery system
| Study group | Role | What they receive |
|---|---|---|
| RBP-6000 | Experimental | A single dose of RBP-6000 will be administered on Study Day 1 Receives: Drug: RBP-6000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of treatment emergent adverse events (safety and tolerability) of a single SC injection of RBP-6000 in subjects with opioid dependence.
The frequency of all adverse events (AE) and serious adverse events (SAE) deemed to be related to treatment.
Measured: Day 1 to Day 85
Secondary outcomes (3)
Maximum plasma concentration (Cmax) for buprenorphine and norbuprenorphine
PK samples to be collected to determine Cmax over the post-injection period
Measured: Day 1 through Day 85
Time to occurrence of Cmax (Tmax) for buprenorphine and norbuprenorphine
PK samples to be collected to determine Tmax over the post-injection period
Measured: Day 1 through Day 85
Area under the plasma concentration versus time curve (AUC) for buprenorphine and norbuprenorphine
AUC to be measured from time 0 to the last sampling time post-injection at which concentrations were at or above the limit of quantitation
Measured: Day 1 through Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 2011
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT02765867
- Sponsor's protocol ID
- RB-US-10-0011
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label Study of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Individuals
- ClinicalTrials.gov ID
- NCT02765867
- Acronym / sponsor ID
- RB-US-10-0011
- Conditions
- Opioid Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 May 2016 (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.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an injection of RBP-6000.
Detailed description
This is an open-label, single-center, first-in-human study, designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of a single subcutaneous (SC) injection of RBP-6000 in opioid dependent subjects. Enrollment will begin with 6 subjects, and additional subjects will not be enrolled until safety through Day 4 has been reviewed and analyzed. Subjects will remain in a residential unit through Day 30 post-injection and will continue with visits to the clinical unit until Day 85 or plasma buprenorphine levels are below 100 pg/mL, whichever comes later. The expected maximum duration of participation for each subject (including screening) is 120 days.
Safety will be assessed by adverse events, electrocardiograms, clinical laboratory assessments, local injection site tolerability and vital signs. PK will be assessed by measuring concentrations of buprenorphine and norbuprenorphine in plasma. The need for rescue medication will be assessed using clinical judgment along with information provided by the COWS scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RBP-6000 | Experimental | Drug: RBP-6000A single dose of RBP-6000 will be administered on Study Day 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- If female, must be surgically sterile or two-years post-menopausal and have a negative pregnancy test. Subjects should take reasonable precautions during the study to avoid pregnancy by agreeing to remain abstinent or to practice double-barrier forms of birth control from study screening through the last dose of study medication.
- Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for opioid dependence and who are seeking opioid-dependence treatment with methadone.
- Willing to cooperate with study procedures and provide written informed consent prior to start of any study procedures.
- Agree not to take any buprenorphine product (other than RBP-6000) throughout their participation in the study.
- Body mass index of ≥ 18 to ≤ 33 kg/m2.
Key exclusion criteria (14 listed)
- Require ongoing opioid therapy for pain or other chronic medical conditions.
- Additionally, individuals who answer "yes" to both of the following questions will be excluded from participation: A) Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than those kinds of pain today? B) If yes, has the pain persisted for three months or more?
- Currently dependent by DSM-IV-TR criteria on any substance other than opioids, caffeine, or nicotine.
- Positive urine screen at intake for barbiturates, benzodiazepines, buprenorphine, or methadone.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the study physician, would jeopardize the safety of the subject.
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-6000A single injection of RBP-6000 containing a low dose of buprenorphine in the Atrigel delivery system | Drug | RBP-6000 |
Primary outcome
To assess the incidence of treatment emergent adverse events (safety and tolerability) of a single SC injection of RBP-6000 in subjects with opioid dependence.
Time frame: Day 1 to Day 85
The frequency of all adverse events (AE) and serious adverse events (SAE) deemed to be related to treatment.
3 secondary outcomes
Maximum plasma concentration (Cmax) for buprenorphine and norbuprenorphine
Time frame: Day 1 through Day 85
Time to occurrence of Cmax (Tmax) for buprenorphine and norbuprenorphine
Time frame: Day 1 through Day 85
Area under the plasma concentration versus time curve (AUC) for buprenorphine and norbuprenorphine
Time frame: Day 1 through Day 85
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 9 May 2016.
- Individual participant dataSharing planned: Undecided
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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 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 7 inclusion and 14 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 9 May 2016. 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?
To assess the incidence of treatment emergent adverse events (safety and tolerability) of a single SC injection of RBP-6000 in subjects with opioid dependence. (time frame: Day 1 to Day 85). 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 9 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.