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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Sykehuset I Vestfold HF	Tonsberg	Norway
Smsoxuwia Thuuvnuy Hb	Skien	Norway
Ayriipbz Utcfvhqpus Hgmaetsa	Lorenskog	Norway
Hyavs Bskcvl Hn	Bergen	Norway

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.09.2022

Trial locations

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.

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 ID:

2023-510404-44-02

Trial Phase:

Therapeutic confirmatory (Phase III)

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