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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Region Oestergoetland	Linkoping	Sweden
Region Stockholm – SLSO	Stockholm	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.02.2024

Trial locations

Investigated drugs:

Buprenorphine

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.

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 ID:

2023-505098-34-00

Protocol code:

INDV-6000-406

NCT ID:

NCT05860959

Trial Phase:

Therapeutic confirmatory (Phase III)

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