Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Phase IV Longitudinal Study of SUBLOCADE (SUBUTEX Prolonged Release) Clinical Outcomes in Adults with Opioid Use Disorder (Opioid Dependence)

This research is a close look at how well SUBLOCADE (also known as Subutex Prolonged Release) works for adults dealing with opioid use disorder. It will track participants over three years to see if they achieve and maintain recovery, which means their symptoms of opioid use disorder have significantly reduced or gone away. Doctors will monitor how many people reach this recovery milestone at different times, like after six months, one year, and up to three years, while they are on this treatment. The study also investigates other important aspects, such as how long people stay on SUBLOCADE, why they might stop treatment, and whether they have any positive opioid use or overdoses. This helps us understand the full picture of how this medication helps people over time.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Indivior Inc.

Enrolment target

Start

15 Feb 2024

Opioid Use Disorder

What is this study about?

This study is important research for adults who are receiving treatment for opioid use disorder. Opioid use disorder is a medical condition where a person has difficulty controlling their use of opioids, even when it causes problems in their life. The main treatment being looked at here is called SUBLOCADE, which is a buprenorphine injection that works for a long time. It's already an approved treatment, but this study, called a Phase IV study, aims to understand its long-term effects in real-world settings.

The main goal of this study is to see how many people achieve 'remission' while on SUBLOCADE. In simple terms, remission means a significant reduction or disappearance of symptoms associated with opioid use disorder, indicating a path towards recovery. The researchers will check for these signs of recovery at several points over three years. This helps them understand how effective SUBLOCADE is at helping people recover and stay well over a longer period.

Beyond simply achieving remission, the study also looks at other key factors. For example, it wants to know if people's symptoms improve over time, how long they stay on SUBLOCADE treatment, and why some people might decide to stop or switch to a different medication. It also monitors for any opioid use or overdoses. By collecting all this information, researchers hope to get a much clearer picture of the full benefits and challenges of using SUBLOCADE for adults with opioid use disorder.

Key takeaways

The study looks at SUBLOCADE (buprenorphine injection) for opioid use disorder.
It checks how well the treatment helps people achieve and maintain recovery.
Researchers will follow participants for up to three years.
The study evaluates symptom improvement, treatment duration, and other health outcomes.
It aims to understand SUBLOCADE's long-term effects in real-world settings.

Who may be eligible?

This study is looking for adult participants. To be considered, you must be at least 18 years old.

The study is for both men and women. If you are an adult receiving treatment for opioid use disorder, you might be suitable for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you an adult?
Are you currently receiving SUBLOCADE (Subutex Prolonged Release) injections?
Are you being treated for opioid use disorder?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be receiving SUBLOCADE injections as part of your treatment for opioid use disorder. The study will mainly involve doctors observing your progress and collecting information about your health over a long period, up to three years.

Throughout the study, healthcare professionals will regularly check in with you to see how you are doing, monitor your symptoms, and track your treatment. They will be particularly interested in whether your symptoms of opioid use disorder are getting better or going away, which is what they call 'remission.' They will also record how long you stay on SUBLOCADE and any reasons why you might stop or change your treatment. You may have regular appointments for these checks and to receive your SUBLOCADE injection if it's part of your ongoing treatment plan.

Potential risks and benefits

Participating in this study means your doctors will be very closely monitoring your progress on SUBLOCADE, which could provide valuable insights into your own treatment journey. The potential benefits could include a deeper understanding of how SUBLOCADE helps with long-term recovery from opioid use disorder. As with any medication, there can be potential risks or side effects from SUBLOCADE, and your medical team will discuss these with you before you start. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is opioid use disorder?

Opioid use disorder is a medical condition where someone has trouble controlling their use of pain-numbing medications like opioids, even when it causes problems in their life.

What is SUBLOCADE?

SUBLOCADE is a long-acting injection of a medication called buprenorphine, used to help treat opioid use disorder.

What does 'remission' mean in this study?

In this study, 'remission' means that symptoms of opioid use disorder have significantly decreased or disappeared, showing a path towards recovery.

How long will this study last?

Participants will be followed for up to three years to understand the long-term effects of SUBLOCADE.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it will not affect your medical care.