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Study on Long-Term Effects of Buprenorphine in Adults with Opioid Use Disorder

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Opioid Use Disorder, a condition where individuals have a strong desire to use opioids, which can lead to significant health issues. The treatment being studied is called SUBLOCADE, which contains the active substance buprenorphine. This medication is given as a solution for injection and is designed to be released slowly over time to help manage opioid dependence.

The purpose of the study is to assess the long-term outcomes of using SUBLOCADE in adults who have a history of moderate to severe opioid use disorder. Participants in the study will receive regular injections of the medication and will be monitored over several years to see how well the treatment helps them manage their condition. The study will look at various outcomes, such as whether participants achieve remission, which means they no longer show symptoms of the disorder, and how long it takes to reach this state.

Throughout the study, participants will be observed for any changes in their symptoms and any potential side effects. The study aims to provide valuable information on the effectiveness and safety of long-term treatment with SUBLOCADE for individuals struggling with opioid use disorder. This research is important for understanding how to best support people in overcoming opioid dependence and improving their quality of life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study is designed for adults aged 18 and over who have signed the informed consent form.

    Participants must have started treatment for opioid use disorder with SUBLOCADE within the last 3 months or have completed a previous SUBLOCADE study and received the last dose within 3 months before the baseline visit.

  2. Step 2

    Baseline visit

    The baseline visit marks the official start of the study for each participant.

    Participants will receive an injection of SUBLOCADE, which is a solution for injection administered subcutaneously.

  3. Step 3

    Treatment phase

    Participants will continue to receive SUBLOCADE injections. The medication is available in two dosages: 300 mg and 100 mg.

    The frequency and duration of the injections will be determined by the study protocol and the participant's response to treatment.

  4. Step 4

    Assessment of outcomes

    The study aims to assess clinical outcomes over a long-term period, focusing on remission and symptom improvement.

    Primary outcomes include achieving remission by 6 months and at various intervals up to 3 years from the baseline.

  5. Step 5

    Monitoring and follow-up

    Participants will be monitored for any symptoms or changes in their condition throughout the study.

    Secondary outcomes include monitoring for any opioid use, overdose incidents, and reasons for discontinuing treatment.

  6. Step 6

    Completion of study

    The study is expected to conclude by August 31, 2027.

    Participants' overall treatment duration and outcomes will be evaluated at the end of the study.

Who can join the trial?

4 criteria

  • Must be an adult who is at least 18 years old and has signed the informed consent form, which is a document that explains the study and confirms your agreement to participate.
  • Plans to receive more injections of **SUBLOCADE**, a medication used to treat **Opioid Use Disorder**, which is a condition where a person has problems due to using opioids.
  • Has started treatment for **Opioid Use Disorder** or opioid dependence with **SUBLOCADE** within the last 3 months before the first visit of the study.
  • Alternatively, has completed a previous study with **SUBLOCADE** and received the last dose within 3 months before the first visit of the study.

Who cannot join the trial?

4 criteria

  • Participants who are not diagnosed with **Opioid Use Disorder**. This means the study is only for those who have or had issues with using opioids.
  • Participants who are not within the specified age range. The study is for certain age groups, so if you are too young or too old, you may not be eligible.
  • Participants who are part of a vulnerable population. This means people who might need special protection or care, like those with certain disabilities or conditions, are not included.
  • Participants who do not meet other specific health criteria set by the study. This could include having other medical conditions that might interfere with the study.
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Investigated drugs

SUBLOCADE is a medication used in the treatment of opioid use disorder, which is also known as opioid dependence. It is designed to help people who have a history of moderate to severe opioid use disorder. The medication works by releasing its active ingredient over a prolonged period, which helps to reduce cravings and withdrawal symptoms associated with opioid dependence. This can support individuals in their recovery journey by helping them maintain stability and avoid relapse.

What is already known about the treatment

Sublocade – Sublocade is administered as a monthly injection under the skin, specifically designed for individuals with opioid use disorder. It is currently approved and used in medical practice to help manage opioid dependence, with ongoing studies to assess its long-term effectiveness. The medication works by slowly releasing buprenorphine, which binds to opioid receptors in the brain, reducing cravings and withdrawal symptoms. It is classified as a partial opioid agonist, providing a safer alternative to full opioid agonists by minimizing the risk of misuse and overdose.

Investigated diseases

Opioid Use Disorder – Opioid Use Disorder is a condition characterized by a problematic pattern of opioid use that leads to significant impairment or distress. Individuals with this disorder may develop a strong desire to use opioids, experience difficulties in controlling their use, and continue using them despite harmful consequences. Over time, they may develop a tolerance, requiring larger amounts to achieve the same effect, and experience withdrawal symptoms when not using the substance. The disorder can affect various aspects of life, including personal relationships, work, and health. It often involves cycles of relapse and remission, with periods of heavy use followed by attempts to quit. The progression of the disorder can vary widely among individuals, influenced by factors such as genetics, environment, and personal circumstances.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505098-34-00Protocol codeINDV-6000-406Estimated enrolment1 200 patientsSponsorIndivior Inc.

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