Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate
Conditions
Brief 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.
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.
Interventions
DRUGSublocade
SUBLOCADE to be administered approximately every 4 weeks per local standard of care
Sponsors
Indivior Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Event (TEAE) Occurrence | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 17 participants who completed the INDV-6000-403 study were screened and enrolled into this extension study.
Participants by arm
| Arm | Count |
|---|---|
| SUBLOCADE All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator (either 100mg or 300mg) for up to 5 total injections
Sublocade: SUBLOCADE to be administered approximately every 4 weeks per local standard of care | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | SUBLOCADE |
|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 12.68 |
| Age, Customized ≥18 to <30 | 4 Participants |
| Age, Customized ≥30 to <45 | 6 Participants |
| Age, Customized ≥45 to <60 | 5 Participants |
| Age, Customized ≥60 to ≤ 65 | 2 Participants |
| Caffeine Use Current | 15 Participants |
| Caffeine Use Never | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Opioids - Last 30 Days Prior to INDV-6000-403 Screening Visit | 29.29 Days STANDARD_DEVIATION 2.91 |
| Opioids - Lifetime Use | 16.16 years STANDARD_DEVIATION 15.246 |
| Opioids - Use via Intravenous Route in Last 30 Days | 5 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 10 Participants |
| Region of Enrollment United States | 17 participants |
| Screening BMI Group 0 to <18.5 (Underweight) | 2 Participants |
| Screening BMI Group ≥18.5 and <25 (Normal) | 12 Participants |
| Screening BMI Group ≥25 and <30 (Overweight) | 1 Participants |
| Screening BMI Group ≥30 (Obesity) | 2 Participants |
| Screening body mass index (BMI) | 22.81 kg/m^2 STANDARD_DEVIATION 4.181 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 8 Participants |
| Tobacco Use Current | 15 Participants |
| Tobacco Use Never | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
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
Population: The safety population was used for the safety analysis, and consisted of all participants who received at least 1 dose of SUBLOCADE
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SUBLOCADE | Treatment Emergent Adverse Event (TEAE) Occurrence | 0 Participants |