A Phase 4 interventional study of Sublocade in Opioid Use Disorder, Severe and Opioid Use Disorder, Moderate, sponsored by Indivior Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Indivior Inc. · Phase 4, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 17 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Indivior Inc. is the lead sponsor of 51 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Sublocade
SUBLOCADE to be administered approximately every 4 weeks per local standard of care
Also known as: Extended release buprenorphine
Treatment Emergent Adverse Event (TEAE) Occurrence
Study will report the number of participants with the occurrence of any TEAE during the treatment period.
Time frame: From time of informed consent at Day 1 until EOT, assessed up until Day 141
A total of 17 participants who completed the INDV-6000-403 study were screened and enrolled into this extension study.
| Milestone | SUBLOCADE |
|---|---|
| Started | 17 |
| Completed | 11 |
| Not completed | 6 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 5 |
Study will report the number of participants with the occurrence of any TEAE during the treatment period.
| Participants | SUBLOCADE |
|---|---|
| Treatment Emergent Adverse Event (TEAE) Occurrence | 0 |
Collected over Adverse events were collected from study Day 1 through end of treatment (EOT), up to Day 141. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SUBLOCADE | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(years) | SUBLOCADE |
|---|---|
| Mean | 40.9 ± 12.68 |
| Age, Customized(Participants) | SUBLOCADE |
|---|---|
| ≥18 to <30 | 4 |
| ≥30 to <45 | 6 |
| ≥45 to <60 | 5 |
| ≥60 to ≤ 65 | 2 |
| Sex: Female, Male(Participants) | SUBLOCADE |
|---|---|
| Female | 9 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | SUBLOCADE |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 16 |
| Unknown or Not Reported | 1 |
| Race/Ethnicity, Customized(Participants) | SUBLOCADE |
|---|---|
| Asian | 1 |
| Black or African American | 5 |
| White | 10 |
| Other | 1 |
| Region of Enrollment(participants) | SUBLOCADE |
|---|---|
| United States | 17 |
| Screening body mass index (BMI)(kg/m^2) | SUBLOCADE |
|---|---|
| Mean | 22.81 ± 4.181 |
| Screening BMI Group(Participants) | SUBLOCADE |
|---|---|
| 0 to <18.5 (Underweight) | 2 |
| ≥18.5 and <25 (Normal) | 12 |
| ≥25 and <30 (Overweight) | 1 |
| ≥30 (Obesity) | 2 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Indivior Inc.