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Comparing Buprenorphine/Naloxone and Methadone for Opioid Use Disorder in Patients with Chronic Pain: A Study on Reducing Opioid Misuse

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 treatment of opioid use disorder in patients who also suffer from chronic pain. The study compares two treatments: Suboxone, which contains the active substances buprenorphine and naloxone, and methadone. Suboxone is taken as a sublingual tablet, meaning it dissolves under the tongue, while methadone is taken orally. The purpose of the study is to compare how effective these treatments are in reducing the misuse of opioids, which are strong pain-relieving drugs.

Participants in the study will be randomly assigned to receive either Suboxone or methadone. The study will last for several months, during which participants will be monitored to see how their opioid use changes over time. They will be asked to complete questionnaires and may undergo various tests to assess their progress. The study aims to provide valuable information on which treatment might be more beneficial for people dealing with both opioid dependency and chronic pain.

Throughout the study, participants will be supported by healthcare professionals to ensure their safety and well-being. The results of this trial could help improve treatment options for individuals struggling with opioid use disorder and chronic pain, offering insights into the best ways to manage these conditions together.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, chronic pain condition, opioid use disorder, and willingness to comply with study procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes completing the Current Opioid Misuse Measure (COMM) questionnaire and other assessments related to pain, quality of life, and mental health.

  3. Step 3

    Treatment allocation

    Participants are randomly assigned to one of two treatment groups: methadone or suboxone (buprenorphine/naloxone).

  4. Step 4

    Medication administration

    For those in the methadone group, the medication is taken orally. The dosage and frequency are determined by the study protocol and adjusted as needed.

    For those in the suboxone group, the medication is taken as a sublingual tablet. The dosage and frequency are also determined by the study protocol and adjusted as needed.

  5. Step 5

    Ongoing assessments

    Participants undergo regular assessments to monitor progress. These include questionnaires and tests to evaluate opioid misuse, pain levels, quality of life, and other health indicators.

  6. Step 6

    Follow-up evaluations

    Follow-up evaluations occur at two and six months after starting treatment. These evaluations compare the effectiveness of methadone and suboxone in reducing opioid misuse and improving other health outcomes.

  7. Step 7

    Completion of study

    The study is estimated to conclude by January 1, 2028. Final assessments are conducted to gather comprehensive data on the long-term effects of the treatments.

Who can join the trial?

7 criteria

  • Must be 18 years or older.
  • Have chronic non-cancer pain, which means ongoing pain that is not related to cancer.
  • Currently using a prescribed opioid with a daily dose equivalent to more than 60 mg of morphine for at least 3 months.
  • Have an opioid use disorder, which is a condition where someone has problems controlling their use of opioids.
  • Want to receive treatment for opioid use disorder.
  • Agree to follow the study procedures.
  • Be able to provide informed consent, meaning you understand the study and agree to participate.

Who cannot join the trial?

4 criteria

  • Patients who are currently using opioids in a way that is not prescribed or recommended by a doctor.
  • Patients who have a history of chronic pain that is not related to cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Suboxone

    This medication is a combination of buprenorphine and naloxone. It is used to help people reduce or quit their use of opioids. Buprenorphine works by partially activating opioid receptors in the brain, which helps to reduce cravings and withdrawal symptoms. Naloxone is included to prevent misuse of the medication by blocking the effects of opioids if Suboxone is injected.

  • Methadone

    This is a medication used to treat opioid addiction and manage chronic pain. It works by fully activating opioid receptors in the brain, which helps to reduce withdrawal symptoms and cravings in people who are addicted to opioids. Methadone is often used as part of a comprehensive treatment plan that includes counseling and support.

What is already known about the treatment

  • Suboxone

    Suboxone is a medication administered orally, typically in the form of a film or tablet placed under the tongue. It is currently used in the treatment of opioid use disorder and is well-documented in medical literature for its effectiveness in reducing opioid misuse. The main therapeutic indications include managing opioid dependence and chronic non-cancer pain. Suboxone works by combining buprenorphine, a partial opioid agonist, with naloxone, an opioid antagonist, to reduce cravings and withdrawal symptoms while minimizing the risk of misuse. It is classified as a combination medication for opioid dependence treatment.

  • Methadone

    Methadone is an oral medication, usually taken as a liquid or tablet, used in the management of opioid use disorder and chronic pain. It is well-established in medical practice and literature for its role in opioid substitution therapy. Methadone's primary therapeutic indications are to alleviate withdrawal symptoms and reduce opioid cravings. It functions as a full opioid agonist, binding to the same receptors in the brain as other opioids, but with a longer duration of action, helping to stabilize patients and prevent misuse. Methadone is classified as an opioid analgesic.

Investigated diseases

  • Opioid Use Disorder

    This condition involves a problematic pattern of opioid use that leads to significant impairment or distress. It is characterized by an intense craving for opioids, increased tolerance, and withdrawal symptoms when not using the substance. Individuals may find it difficult to control or reduce their opioid use despite negative consequences. The disorder often results in neglect of responsibilities and activities, and it can lead to social and interpersonal issues. Over time, the disorder can cause physical and psychological dependence on opioids.

  • Chronic Non-Cancer Pain

    This condition refers to persistent pain that lasts for more than three months and is not associated with cancer. It can arise from various causes, including injury, surgery, or conditions like arthritis. The pain can be continuous or intermittent and may vary in intensity. It often affects daily activities and can lead to emotional distress, such as anxiety or depression. Individuals with chronic non-cancer pain may experience difficulties in maintaining a normal lifestyle due to the ongoing discomfort.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513924-41-01Estimated enrolment100 patientsSponsorStichting Radboud universitair medisch centrum

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