Opioid Use DisorderPhase 3NCT02896296
Open-Label Treatment Extension Study
A Phase 3 study testing RBP-6000 in people with Opioid Use Disorder and Opioid-related Disorders, run by Indivior Inc. at 29 sites in United States.
Trial summary
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder, Opioid-related Disorders
- 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
- 208 participants
- Where
- 29 sitesUnited States
- Study dates
- 17 Aug 2016to 23 Aug 2017
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written consent to participate in this study.
- Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014).
- Be considered eligible in the medical judgment of the Investigator.
- Females: Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent form (ICF)) must have a negative 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: Subjects with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the ICF through at least 6 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
- Subjects must agree not to take any buprenorphine products other than those administered during the current study throughout participation in the study.
- Subjects must be willing to adhere to study procedures.
Who cannot join
- Subject compliance issues during participation in the RB-US-13-0003 study which, in the opinion of the Investigator, could potentially compromise subject safety.
- Women of childbearing potential who have a positive pregnancy test at RB-US-13-0003 at the end-of-study (EOS) visit, who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study.
- History of suicidal ideation within 28 days prior to signing the ICF as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) "since last visit" assessment (completed in the EOS Visit for Study RB-US-13-0003), screening/baseline" assessment for the current study), or history of a suicide attempt (per the C-SSRS) in the 6 months prior to signing the ICF.
- Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported additional buprenorphine, or over the counter (OTC) and/or herbal supplements with the potential to prolong QTc within 28 days of Day 1 unless prior written approval was obtained from the Medical Monitor.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Keystone Clinical Solutions
Altoona, Pennsylvania, 16601
Hassman Research Institute
Berlin, New Jersey, 08009
Neuro-behavioral Clinical Research
Canton, Ohio, 44708
Carolina Clinical Trials
Charleston, South Carolina, 29407
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Pillar Clinical Research
Dallas, Texas, 75243
Midwest Clinical Research Center
Dayton, Ohio, 45417
InSite Clinical Research
DeSoto, Texas, 75115
Stanley Street Treatment and Resources
Fall River, Massachusetts, 02720
Precise Research Centers, Inc.
Flowood, Mississippi, 39232
Sarkis Clinical Trials
Gainesville, Florida, 32607
Rakesh Ranjan MD & Associates, Inc.
Garfield Heights, Ohio, 44125
Boyett Health Services
Hamilton, Alabama, 35570
Amit Vijapura
Jacksonville, Florida, 32256
Meridien Research
Lakeland, Florida, 33805
Altea Research
Las Vegas, Nevada, 89102
Innovative Clinical Research
Lauderhill, Florida, 33319
Woodland International Research Group
Little Rock, Arkansas, 72211
Collaborative Neuroscience Network
Long Beach, California, 90806
Louisiana Research Associates
New Orleans, Louisiana, 70114
Scientific Clinical Research
North Miami, Florida, 33161
Pacific Research Partners
Oakland, California, 94612
Pahl Pharmaceutical Professionals
Oklahoma City, Oklahoma, 73112
SP Research, PLLC
Oklahoma City, Oklahoma, 73112
CODA
Portland, Oregon, 97232
Phoenix Medical Research
Prairie Village, Kansas, 66206
Louisiana Clinical Research
Shreveport, Louisiana, 71101
St Louis Clinical Trials
St Louis, Missouri, 63141
Adams Clinical Trials
Watertown, Massachusetts, 02472
About this study
Official title: An Open-Label, Depot Buprenorphine (RBP-6000) Treatment Extension Study in Subjects With Opioid Use Disorder
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
Read the detailed description
This is a multi-center, open-label, RBP-6000 treatment extension study in which subjects who have completed the End of Study (EOS) procedures for study RB-US-13-0003 are eligible. EOS assessments completed at the RB-US-13-0003 EOS visit serve as part of the screening visit for this study. In addition, subjects were requested to complete a Columbia Suicide Severity Rating Scale (C-SSRS) baseline/screening survey and a medical history and height was obtained.
The informed consent may be shared with subjects up to 2 months prior to the RB-US-13-0003 EOS visit, however should not be signed until all assessments for the EOS visit have been completed.
On Day 1, eligible subjects receive a subcutaneous (SC) injection of RBP-6000 at a low or high dose based on the medical judgment of the investigator. After the injection, vital signs and the injection site were assessed. Prior to departing the site, subjects were also assessed for adverse events (AEs) and use of concomitant medications (ConMeds).
Subjects return to the site for monthly injection visits every 28 days (-2 / +7 days) for a total of up to 6 injections (participants were not required to complete all 6 injections). At each subsequent visit (Injections 2 through 6) the following procedures / assessments were performed : urine pregnancy test performed for all female subjects who are of childbearing potential before each injection; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; vital signs collected pre and post each injection; RBP-6000 injection, urine drug screen (UDS); C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; local injection site grading, subject self-assessment of injection site pain (Injection Site Pain Visual Analog Scale [VAS]), assessment for adverse events (AEs).
Laboratory tests (hematology, chemistry and urinalysis) may be requested by the Investigator on an ad-hoc basis in order to assess for AEs.
A subject's alternative treatment options were assessed at least two months before EOS at each visit.
At EOS or early termination (ET), the following assessments were performed: urine pregnancy test performed for all female subjects who are of childbearing potential; vital signs; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; UDS; C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; assessment for AEs; a brief physical exam; height and body weight were measured and a subject's body mass index (BMI) and waist-to-hip ratio calculated; laboratory tests (hematology, chemistry, urinalysis).
Subjects were to be contacted by telephone approximately 4 weeks after EOS/ET for a safety follow-up assessment of AEs and use of ConMeds.
- Conditions
- Opioid Use Disorder, Opioid-related Disorders
- 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
Also called atrigel buprenorphine, extended-release buprenorphine
Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose could be adjusted from 100 mg to 300 mg (or the reverse) based on the medical judgment of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| RBP-6000 (100/300 mg Flex) | Experimental | On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time.
For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator. Receives: Drug: RBP-6000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measured: Day 1 up to Week 29
Percentage Change From Baseline to Week 25 in Vital Signs
Vital signs include:
- systolic blood pressure (mmHg)
- diastolic blood pressure (mmHg)
- respiratory rate (breaths/minute)
- pulse oximetry (%)
- pulse rate (beats/min)
- temperature (C)
Measured: Day 1, Week 25
Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. The number of participants with TEAEs specific to laboratory tests are summarized.
Measured: Day 1 up to Week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start17 Aug 2016
- Primary completion23 Aug 2017
- Study completion23 Aug 2017
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Director Clinical Development, Study director, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896296
- Sponsor's protocol ID
- INDV-6000-301
- Status last verified
- Nov 2018
- First submitted
- 6 Sep 2016
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided
Publications
Rutrick D, Learned SM, Boyett B, Hassman D, Shinde S, Zhao Y. 18-Month efficacy and safety analysis of monthly subcutaneous buprenorphine injection for opioid use disorder: Integrated analysis of phase 3 studies. J Subst Use Addict Treat. 2023 Nov;154:209155. doi: 10.1016/j.josat.2023.209155. Epub 2023 Aug 30.
PubMed 37657559Craft WH, Tegge AN, Keith DR, Shin H, Williams J, Athamneh LN, Stein JS, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug Alcohol Depend. 2022 May 1;234:109389. doi: 10.1016/j.drugalcdep.2022.109389. Epub 2022 Mar 9.
PubMed 35287034
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Depot Buprenorphine (RBP-6000) Treatment Extension Study in Subjects With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT02896296
- Acronym / sponsor ID
- INDV-6000-301
- Conditions
- Opioid Use Disorder, Opioid-related Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
Detailed description
This is a multi-center, open-label, RBP-6000 treatment extension study in which subjects who have completed the End of Study (EOS) procedures for study RB-US-13-0003 are eligible. EOS assessments completed at the RB-US-13-0003 EOS visit serve as part of the screening visit for this study. In addition, subjects were requested to complete a Columbia Suicide Severity Rating Scale (C-SSRS) baseline/screening survey and a medical history and height was obtained.
The informed consent may be shared with subjects up to 2 months prior to the RB-US-13-0003 EOS visit, however should not be signed until all assessments for the EOS visit have been completed.
On Day 1, eligible subjects receive a subcutaneous (SC) injection of RBP-6000 at a low or high dose based on the medical judgment of the investigator. After the injection, vital signs and the injection site were assessed. Prior to departing the site, subjects were also assessed for adverse events (AEs) and use of concomitant medications (ConMeds).
Subjects return to the site for monthly injection visits every 28 days (-2 / +7 days) for a total of up to 6 injections (participants were not required to complete all 6 injections). At each subsequent visit (Injections 2 through 6) the following procedures / assessments were performed : urine pregnancy test performed for all female subjects who are of childbearing potential before each injection; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; vital signs collected pre and post each injection; RBP-6000 injection, urine drug screen (UDS); C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; local injection site grading, subject self-assessment of injection site pain (Injection Site Pain Visual Analog Scale [VAS]), assessment for adverse events (AEs).
Laboratory tests (hematology, chemistry and urinalysis) may be requested by the Investigator on an ad-hoc basis in order to assess for AEs.
A subject's alternative treatment options were assessed at least two months before EOS at each visit.
At EOS or early termination (ET), the following assessments were performed: urine pregnancy test performed for all female subjects who are of childbearing potential; vital signs; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; UDS; C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; assessment for AEs; a brief physical exam; height and body weight were measured and a subject's body mass index (BMI) and waist-to-hip ratio calculated; laboratory tests (hematology, chemistry, urinalysis).
Subjects were to be contacted by telephone approximately 4 weeks after EOS/ET for a safety follow-up assessment of AEs and use of ConMeds.
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 (100/300 mg Flex) | Experimental | Drug: RBP-6000On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide written consent to participate in this study.
- Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014).
- Be considered eligible in the medical judgment of the Investigator.
- Females: Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent form (ICF)) must have a negative 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: Subjects with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the ICF through at least 6 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
Key exclusion criteria (4 listed)
- Subject compliance issues during participation in the RB-US-13-0003 study which, in the opinion of the Investigator, could potentially compromise subject safety.
- Women of childbearing potential who have a positive pregnancy test at RB-US-13-0003 at the end-of-study (EOS) visit, who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study.
- History of suicidal ideation within 28 days prior to signing the ICF as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) "since last visit" assessment (completed in the EOS Visit for Study RB-US-13-0003), screening/baseline" assessment for the current study), or history of a suicide attempt (per the C-SSRS) in the 6 months prior to signing the ICF.
- Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported additional buprenorphine, or over the counter (OTC) and/or herbal supplements with the potential to prolong QTc within 28 days of Day 1 unless prior written approval was obtained from the Medical Monitor.
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: atrigel buprenorphine, extended-release buprenorphineMonthly injections subcutaneously on alternate sides of participant's abdomen. Dose could be adjusted from 100 mg to 300 mg (or the reverse) based on the medical judgment of the investigator. | Drug | RBP-6000 (100/300 mg Flex) |
Primary outcome
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period
Time frame: Day 1 up to Week 29
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition.
Percentage Change From Baseline to Week 25 in Vital Signs
Time frame: Day 1, Week 25
Vital signs include: * systolic blood pressure (mmHg) * diastolic blood pressure (mmHg) * respiratory rate (breaths/minute) * pulse oximetry (%) * pulse rate (beats/min) * temperature (C)
Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values
Time frame: Day 1 up to Week 25
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. The number of participants with TEAEs specific to laboratory tests are summarized.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37657559Rutrick D, Learned SM, Boyett B, Hassman D, Shinde S, Zhao Y. 18-Month efficacy and safety analysis of monthly subcutaneous buprenorphine injection for opioid use disorder: Integrated analysis of phase 3 studies. J Subst Use Addict Treat. 2023 Nov;154:209155. doi: 10.1016/j.josat.2023.209155. Epub 2023 Aug 30.
- Derived from this study: PubMed 35287034Craft WH, Tegge AN, Keith DR, Shin H, Williams J, Athamneh LN, Stein JS, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug Alcohol Depend. 2022 May 1;234:109389. doi: 10.1016/j.drugalcdep.2022.109389. Epub 2022 Mar 9.
- 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.
Global Director Clinical Development study director
Indivior Inc.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RBP-6000 in people with Opioid Use Disorder and Opioid-related Disorders, run by Indivior Inc. at 29 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 7 inclusion and 4 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 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2018). 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?
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period (time frame: Day 1 up to Week 29). The study lists 3 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 NCT02896296, which also lists 2 linked publications.
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 29 Nov 2018.