Opioid Use Disorder, SeverePhase 4NCT04060654
SUBLOCADE Rapid Initiation Extension Study
A Phase 4 study testing Sublocade in people with Opioid Use Disorder, Severe and Opioid Use Disorder, Moderate, run by Indivior Inc. at 1 site in United States.
Trial summary
A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate
- What is being tested?
- Sublocade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2019to 15 May 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
- Completed the EOT Visit for the INDV-6000-403 Study.
- Is an appropriate candidate in the opinion of the Investigator or medically qualified sub-Investigator.
Who cannot join
- Subject compliance issues during participation in the INDV-6000-403 study which, in the opinion of the Investigator, could potentially compromise subject safety.
- Subjects who are unable, in the opinion of the Investigator or Indivior, to comply fully with the study requirements including those who are currently incarcerated or pending incarceration legal action.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hassman Research Institute
Berlin, New Jersey, 08009
About this study
Official title: An Open-label, Treatment Extension Study for the Rapid Initiation of Extended-Release Buprenorphine Subcutaneous Injection (SUBLOCADE™)
A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.
Read the detailed description
This study is being conducted to assess the longer-term safety of an abbreviated initiation protocol of SUBLOCADE in subjects who have completed the INDV-6000-403 study. It is also to provide treatment to these individuals while they seek longer-term treatment arrangements, as on average it can take an individual with opioid use disorder (OUD) 6 months between seeking treatment and achieving an appointment at a provider in the United States (US).
Subjects who have completed the end of treatment (EOT) procedures for the INDV-6000-403 study may be eligible for participation. It is planned that the EOT visit for INDV-6000-403, which will occur approximately 28 days after the subject's first dose of SUBLOCADE, and Day 1 for INDV-6000-404 will occur within 2 days of the EOT visit, and that EOT assessments will serve as the screening assessments for this study.
On Day 1, eligible subjects will receive a subcutaneous (SC) injection of 300 mg SUBLOCADE. Subjects will return to the clinic for subsequent injections approximately every 4 weeks for a total of up to 5 injections. Adverse events and concomitant medications will be captured throughout the study, female subjects of childbearing potential will receive urine pregnancy tests and all subjects will have urine drug screening (UDS) and evaluation of the previous injection site performed. Subjects will otherwise be treated in accordance with local standard of care, and SUBLOCADE doses will be based on the medical judgment of the Investigator.
- Being tested
- Sublocade
- Medical subject headings
- Opioid-Related Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SublocadeDrug
Also called Extended release buprenorphine
SUBLOCADE to be administered approximately every 4 weeks per local standard of care
| Study group | Role | What they receive |
|---|---|---|
| SUBLOCADE | Experimental | All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator (either 100 mg or 300 mg) for up to 5 total injections Receives: Drug: Sublocade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Event (TEAE) Occurrence
Study will report the number of participants with the occurrence of any TEAE during the treatment period.
Measured: From time of informed consent at Day 1 until EOT, assessed up until Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start21 Oct 2019
- Primary completion15 May 2020
- Study completion15 May 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use Disorder, SevereStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- After an initial injection of 300mg SUBLOCADE, all subjects will receive SUBLOCADE doses of 100mg or 300mg based on the medical judgement of the Investigator
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hassman, Principal investigator, Hassman Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060654
- Sponsor's protocol ID
- INDV-6000-404
- Status last verified
- Mar 2025
- First submitted
- 15 Aug 2019
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mariani JJ, Dobbins RL, Heath A, Gray F, Hassman H. Open-label investigation of rapid initiation of extended-release buprenorphine in patients using fentanyl and fentanyl analogs. Am J Addict. 2024 Jan;33(1):8-14. doi: 10.1111/ajad.13484. Epub 2023 Nov 8.
PubMed 37936553
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Treatment Extension Study for the Rapid Initiation of Extended-Release Buprenorphine Subcutaneous Injection (SUBLOCADE™)
- ClinicalTrials.gov ID
- NCT04060654
- Acronym / sponsor ID
- INDV-6000-404
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Posted 25 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.
Detailed description
This study is being conducted to assess the longer-term safety of an abbreviated initiation protocol of SUBLOCADE in subjects who have completed the INDV-6000-403 study. It is also to provide treatment to these individuals while they seek longer-term treatment arrangements, as on average it can take an individual with opioid use disorder (OUD) 6 months between seeking treatment and achieving an appointment at a provider in the United States (US).
Subjects who have completed the end of treatment (EOT) procedures for the INDV-6000-403 study may be eligible for participation. It is planned that the EOT visit for INDV-6000-403, which will occur approximately 28 days after the subject's first dose of SUBLOCADE, and Day 1 for INDV-6000-404 will occur within 2 days of the EOT visit, and that EOT assessments will serve as the screening assessments for this study.
On Day 1, eligible subjects will receive a subcutaneous (SC) injection of 300 mg SUBLOCADE. Subjects will return to the clinic for subsequent injections approximately every 4 weeks for a total of up to 5 injections. Adverse events and concomitant medications will be captured throughout the study, female subjects of childbearing potential will receive urine pregnancy tests and all subjects will have urine drug screening (UDS) and evaluation of the previous injection site performed. Subjects will otherwise be treated in accordance with local standard of care, and SUBLOCADE doses will be based on the medical judgment of the Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After an initial injection of 300mg SUBLOCADE, all subjects will receive SUBLOCADE doses of 100mg or 300mg based on the medical judgement of the Investigator
| Arm | Type | Receives |
|---|---|---|
| SUBLOCADE | Experimental | Drug: SublocadeAll subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator (either 100 mg or 300 mg) for up to 5 total injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
- Completed the EOT Visit for the INDV-6000-403 Study.
- Is an appropriate candidate in the opinion of the Investigator or medically qualified sub-Investigator.
Key exclusion criteria (2 listed)
- Subject compliance issues during participation in the INDV-6000-403 study which, in the opinion of the Investigator, could potentially compromise subject safety.
- Subjects who are unable, in the opinion of the Investigator or Indivior, to comply fully with the study requirements including those who are currently incarcerated or pending incarceration legal action.
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 |
|---|---|---|
| SublocadeAlso: Extended release buprenorphineSUBLOCADE to be administered approximately every 4 weeks per local standard of care | Drug | SUBLOCADE |
Primary outcome
Treatment Emergent Adverse Event (TEAE) Occurrence
Time frame: From time of informed consent at Day 1 until EOT, assessed up until Day 141
Study will report the number of participants with the occurrence of any TEAE during the treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37936553Mariani JJ, Dobbins RL, Heath A, Gray F, Hassman H. Open-label investigation of rapid initiation of extended-release buprenorphine in patients using fentanyl and fentanyl analogs. Am J Addict. 2024 Jan;33(1):8-14. doi: 10.1111/ajad.13484. Epub 2023 Nov 8.
- 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.
Michael Hassman principal investigator
Hassman Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sublocade in people with Opioid Use Disorder, Severe and Opioid Use Disorder, Moderate, 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 3 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 25 Mar 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 25 Jan 2021). 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?
Treatment Emergent Adverse Event (TEAE) Occurrence (time frame: From time of informed consent at Day 1 until EOT, assessed up until Day 141). 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 NCT04060654, which also lists 1 linked publication.
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 25 Mar 2025.