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Study on Baclofen for Reducing Benzodiazepine Use in Patients with Benzodiazepine Dependence

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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 effectiveness of a medication called baclofen in helping people reduce their use of benzodiazepines, which are medications often used to treat anxiety and sleep disorders. The study is particularly interested in patients who have developed a dependence on benzodiazepines, a condition known as benzodiazepine use disorder. Baclofen is a muscle relaxant that is being tested to see if it can help patients lower their benzodiazepine doses more effectively compared to a placebo.

The purpose of the study is to assess whether baclofen can aid in reducing the amount of benzodiazepines that patients take. Participants in the study will be randomly assigned to receive either baclofen or a placebo. The study will last for several weeks, during which time participants will gradually reduce their benzodiazepine intake under medical supervision. The study will monitor the total benzodiazepine consumption before and after the treatment period to evaluate the effectiveness of baclofen.

Throughout the study, researchers will also keep track of any side effects or adverse events that participants may experience. Additionally, the study will assess other factors such as anxiety levels, depression symptoms, sleep quality, and overall quality of life. The goal is to determine if baclofen can be a helpful tool in managing benzodiazepine dependence and improving the well-being of patients with this condition.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, benzodiazepine use disorder, and previous treatment history.
Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception throughout the trial.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline benzodiazepine consumption over the 28 days prior to inclusion.
This includes calculating the average daily dosage in mg-diazepam equivalents.
Step 3
Randomization and treatment
Participants are randomly assigned to receive either baclofen or a placebo.
The treatment involves oral administration of the assigned medication.
Step 4
Treatment period
The treatment period lasts until Day 62/64, during which the efficacy of baclofen in reducing benzodiazepine doses is assessed.
Participants continue their benzodiazepine tapering schedule as part of the study.
Step 5
Monitoring and assessments
Throughout the trial, participants are monitored for adverse events and benzodiazepine discontinuation.
Various assessments are conducted, including withdrawal severity, craving, anxiety, depression, sleep quality, and quality of life.
Step 6
Final evaluation
At the end of the treatment period, a final evaluation is conducted to compare benzodiazepine consumption before and after the trial.
The primary endpoint is the difference in total benzodiazepine consumption in mg-diazepam.

Who can join the trial?

9 criteria

Patients must be between 18 and 65 years old.
Women who can have children must have a negative pregnancy test at the start and use effective birth control during the study. They must also agree to take pregnancy tests throughout the study.
Patients must have a **benzodiazepine use disorder (BUD)**, which is a condition where someone has problems due to using benzodiazepines, as defined by specific guidelines called DSM-5 criteria.
The average daily dose of benzodiazepines should be between 50 mg and 200 mg of diazepam, based on a specific table that compares different medications, for the 28 days before joining the study. Other similar medications like zolpidem, zopiclone, and eszopiclone will be counted as part of this total dose.
Patients must have been using benzodiazepines for more than 12 weeks.
Patients must have tried to stop using benzodiazepines at least once before and not succeeded. This means they couldn't stop taking the full dose as planned with their doctor.
Patients must be part of a social security system.
Patients must be able to give their free, informed, and written consent to participate.
Patients can participate whether or not they have a legal guardian.

Who cannot join the trial?

4 criteria

Patients with **psychiatric disorders** cannot participate. This includes conditions that affect a person's mood, thinking, and behavior.
Patients with **addictology** issues are excluded. This refers to problems related to addiction or substance use disorders.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might be at a higher risk of harm or exploitation, are not eligible.

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Hospices Civils De Lyon
Responsive
Lyon, France

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Investigated drugs

Baclofen is a medication being studied for its potential to help reduce the use of benzodiazepines in people who are dependent on them. It is typically used to treat muscle spasms, but in this trial, researchers are exploring whether it can assist in managing benzodiazepine dependence by helping patients lower their benzodiazepine doses.

What is already known about the treatment

Baclofen – Baclofen is typically administered orally in tablet form. It is currently being studied in clinical trials for its potential to help reduce benzodiazepine doses in individuals with benzodiazepine use disorder. The main therapeutic indication being explored is its use in psychiatric disorders related to addiction. Baclofen works by activating specific receptors in the brain, which helps to decrease muscle spasms and may also influence neurotransmitter release, potentially aiding in addiction treatment. It is classified as a muscle relaxant and antispastic agent.

Investigated diseases

Benzodiazepine Use Disorder – This condition involves the excessive or inappropriate use of benzodiazepines, a class of medications typically prescribed for anxiety, insomnia, or other conditions. Over time, individuals may develop a tolerance, requiring higher doses to achieve the same effects, and may experience withdrawal symptoms if they reduce or stop usage. The disorder can lead to significant impairment in daily functioning, affecting personal, social, and occupational aspects of life. It often involves a cycle of craving and compulsive use, despite negative consequences. The progression of the disorder can vary, with some individuals experiencing more severe symptoms and challenges in reducing or discontinuing use.