CompletedPhase 4

SUBLOCADE Rapid Initiation Extension Study

United States17 participantsStarted 2019-10-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Emergent Adverse Event (TEAE) Occurrence

Timeframe: From time of informed consent at Day 1 until EOT, assessed up until Day 141

Trial details

NCT IDNCT04060654

SponsorIndivior Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-15

Results submitted2021-01-05

View on ClinicalTrials.gov More Opioid Use Disorder, Severe trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.