Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of diazepam and oxazepam in patients with benzodiazepine and opioid dependence who are receiving opioid agonist therapy

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial focuses on treating patients who have comorbid dependencies to both benzodiazepines and opioids. The study aims to compare two different approaches for managing benzodiazepine dependence in patients who are already receiving opioid agonist therapy. The medications being tested are diazepam (Valium, Stesolid) and oxazepam (Sobril), which are commonly prescribed medications used to treat anxiety and similar conditions.

The purpose of this study is to evaluate whether maintaining patients on a stable dose of diazepam or oxazepam for 24 weeks works better than gradually reducing the dose over 20 weeks. The main focus is on measuring how these different approaches affect the use of unauthorized benzodiazepines. The medications will be given as tablets that are taken by mouth.

During the study, participants will be monitored for their mental health symptoms, reaction time, quality of life, and overall satisfaction with the treatment. The study will also track the use of other substances, any violent behavior, and safety-related events. Regular urine tests will be conducted to measure the presence of unauthorized substances. The total duration of treatment in the study is 24 weeks.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    A medical doctor will conduct a clinical assessment to confirm eligibility for participation

    The assessment will verify benzodiazepine dependence history of at least 5 years and current use equivalent to 15 mg diazepam or higher daily

    Current participation in opioid agonist therapy will be confirmed

  2. Step 2

    Treatment assignment

    Random assignment to one of two treatment groups:

    Group 1: 24-week stable dose of diazepam or oxazepam tablets

    Group 2: 20-week gradual dose reduction of diazepam or oxazepam tablets

  3. Step 3

    Treatment period

    Duration: 24 weeks total

    Regular urine tests to monitor substance use

    Completion of health questionnaires measuring mental health symptoms

    Assessment of reaction time through a standardized test

    Quality of life evaluation using standardized questionnaires

    Monitoring of treatment satisfaction

  4. Step 4

    Regular monitoring

    Assessment of any substance use through urine tests and self-reporting

    Monitoring of behavior using standardized checklists

    Documentation of any health-related incidents

    Tracking of participation in opioid agonist therapy

  5. Step 5

    Final assessment

    Completion of final health evaluations

    Comparison of results with initial assessments

    Final urine testing

    Documentation of overall treatment experience

Who can join the trial?

9 criteria

  • Must be at least 18 years old
  • Must be diagnosed with opioid dependence (a chronic disorder where a person is physically and mentally dependent on opioid drugs) and currently receiving OAT (Opioid Agonist Therapy - a medical treatment for opioid dependence)
  • Must have benzodiazepine dependence (physical and psychological dependence on anti-anxiety medications) meeting these specific conditions:
    • Been dependent for at least 5 years
    • Using benzodiazepines 5-7 days per week in the last month
    • Taking a daily dose equal to or higher than 15 mg of diazepam
    • Must have previously attempted to stop using benzodiazepines through outpatient or inpatient programs
    • Must be able to understand and sign an informed consent form
    • Must be willing to comply with all study requirements and restrictions
    • Must be evaluated and approved by a medical doctor to confirm eligibility

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 65 years
  • Known allergies or hypersensitivity to benzodiazepines (anxiety and sleep medications) or opioids (strong pain medications)
  • Pregnant or breastfeeding women
  • Severe liver disease that affects medication processing
  • Severe breathing problems or sleep apnea (breathing stops during sleep)
  • Current severe mental health conditions requiring immediate treatment
  • Active suicidal thoughts or behavior
  • Current participation in other clinical trials
  • Unable to provide informed consent
  • Severe medical conditions that could interfere with study participation
  • History of severe adverse reactions to similar medications
  • Current use of medications that could dangerously interact with study drugs
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Diazepam

    is a medication from the benzodiazepine family used to treat anxiety, muscle spasms, and seizures. In this trial, it is used as a stabilizing treatment for patients who are dependent on benzodiazepines while they undergo opioid therapy. It helps reduce anxiety and withdrawal symptoms.

  • Oxazepam

    is also a benzodiazepine medication that helps treat anxiety and insomnia. Like diazepam, it is being studied as a stabilizing treatment for patients with benzodiazepine dependence who are receiving opioid therapy. It works by calming the central nervous system and helping to manage withdrawal symptoms.

  • Opioid Agonist Therapy (OAT)

    is a treatment approach that uses medications to help people who are dependent on opioids. This therapy helps manage withdrawal symptoms and cravings while patients work toward recovery. It is the underlying treatment that all participants in this trial receive while being studied for benzodiazepine stabilization.

What is already known about the treatment

  • Diazepam

    An oral benzodiazepine medication administered in tablet form that belongs to the anxiolytic and sedative drug class. It works by enhancing the effects of GABA, a natural calming chemical in the brain, making it effective for treating anxiety, muscle spasms, and seizures. In this clinical trial, it is being studied as a stabilizing treatment for patients who have both benzodiazepine and opioid dependencies while undergoing opioid agonist therapy.

  • Oxazepam

    A benzodiazepine medication taken orally in tablet form that acts as an anxiolytic and sedative by increasing GABA neurotransmitter activity in the brain. It is generally considered to have a shorter half-life and milder effects compared to diazepam, making it particularly suitable for elderly patients and those with liver conditions. In this clinical trial, it is being evaluated as an alternative stabilizing treatment for patients with dual benzodiazepine and opioid dependencies during opioid agonist therapy.

Investigated diseases

  • Benzodiazepine Dependence

    A chronic condition where a person becomes physically and psychologically dependent on benzodiazepine medications, which are commonly prescribed for anxiety and sleep disorders. The condition develops through regular use of these medications, leading to tolerance where increasing amounts are needed to achieve the same effect. When stopping the medication, individuals may experience withdrawal symptoms including anxiety, tremors, and sleep disturbances.

  • Opioid Dependence

    A chronic medical condition characterized by a problematic pattern of opioid use that leads to significant impairment or distress. The condition involves physical dependence where the body adapts to the presence of opioids, resulting in tolerance and withdrawal symptoms when use is reduced or stopped. Regular opioid use can lead to changes in brain chemistry affecting motivation, reward, and decision-making processes.

  • Comorbid Benzodiazepine and Opioid Dependence

    A complex condition where an individual is simultaneously dependent on both benzodiazepines and opioids. This dual dependence creates more severe physical and psychological symptoms than single-substance dependence. The condition often develops when both types of medications are used together, either prescribed or obtained illicitly. The combined effects of both substances can intensify withdrawal symptoms and complicate the overall condition.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510404-44-02Estimated enrolment108 patientsSponsorHelse Bergen HF

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.