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Zopiclone

Clinical trials investigating Zopiclone are studying its role in a patient group with benzodiazepine dependence and related psychiatric or addiction disorders. These studies focus on outcomes such as changes in benzodiazepine use and compare Zopiclone with other study treatments or placebo. They help show how Zopiclone is being evaluated in real research settings.

Table of contents

Trial overview

The provided clinical trial data include one study that mentions Zopiclone as one of the study drugs.[1] This trial is titled “BACLOFEN FOR IMPROVING BENZODIAZEPINE TITRATION IN BENZODIAZEPINE DEPENDENCE. BABET,” and it is an interventional study in Phase 4.[1] The study is authorised and plans to enroll 93 participants.[1]

Who the trial is for

The trial targets people with psychiatric disorders and addictology conditions, which means mental health and addiction-related problems.[1] The brief summary says the study is designed for patients with benzodiazepine use disorder, a condition where benzodiazepine use causes harm or is hard to control.[1] This means the study is not aimed at healthy volunteers, but at a patient group with dependence-related needs.[1]

Study design and treatment groups

This is an interventional trial, which means the researchers assign study treatments and then measure the results.[1] The intervention list includes baclofen, ZOLPIDEM, ZOPICLONE, cellulose microcristalline, and placebo-like entries shown as “-” in the record.[1] The trial summary states that baclofen is being compared to placebo to see whether it helps reduce benzodiazepine doses.[1]

In the source data, randomisation is used, which means participants are assigned by chance to study groups.[1] This helps make the comparison between groups fairer and reduces bias, which is when results are influenced by the way groups are chosen rather than by the treatment itself.[1]

What is being measured

The main outcome is the difference in total benzodiazepine use, measured in mg-diazepam, between the 28 days before study entry and the last 28 days before the final visit on Day 62/64 of randomisation.[1] Diazepam-equivalent measurement is a way to compare different benzodiazepines using one common scale.[1] This outcome shows whether the study treatment helps lower benzodiazepine consumption over time.[1]

The study brief summary says the goal is to assess the efficacy of baclofen compared with placebo in reducing benzodiazepine doses in patients with benzodiazepine use disorder.[1] Although Zopiclone appears in the intervention list, the source data do not describe Zopiclone as the main study question by itself.[1]

Trial status and size

The trial status is listed as Authorised, meaning it has approval to proceed in the setting described in the record.[1] The planned enrollment is 93 participants, which is the number of people the researchers expect to include.[1] The study is in Phase 4, so it is being done in a later stage of clinical research rather than an early testing stage.[1]

Why this research matters

This trial is important because it studies treatment approaches for people who have difficulty reducing benzodiazepine use.[1] By measuring changes in benzodiazepine consumption over a defined time period, the researchers can learn whether the study approach helps patients lower use more successfully.[1] The presence of Zopiclone in the intervention list shows that it is part of the clinical research setting described in the record.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05935553 Phase 4 Psychiatric disorders, addictology; benzodiazepine dependence Authorised 93

FAQ

  • What clinical trial is studying Zopiclone? One authorised Phase 4 trial is studying Zopiclone in people with benzodiazepine dependence and related psychiatric or addiction disorders. The trial looks at how study treatments affect benzodiazepine use over time.
  • Who may take part in the Zopiclone trial? The trial is focused on patients with benzodiazepine use disorder and related psychiatric or addictology conditions. It is not a general healthy-volunteer study.
  • What is the main goal of the trial involving Zopiclone? The main goal is to measure the change in total benzodiazepine use, converted to diazepam milligrams. This helps researchers see whether the study treatment reduces benzodiazepine consumption.
  • What phase is the Zopiclone trial? The trial is in Phase 4. Phase 4 studies are done after earlier testing and are used to learn more about how a treatment performs in a patient group.
  • How many people are in the Zopiclone trial? The trial plans to include 93 participants. This number helps researchers collect enough data to compare the study groups.

Ongoing Clinical Trials on Zopiclone

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

    Recruiting

    4 1 1
    Investigated drugs:
    France

Glossary

  • Benzodiazepine dependence: A condition where a person has become dependent on benzodiazepines and may have trouble reducing or stopping them.
  • Benzodiazepine use disorder: A medical condition where benzodiazepine use causes harm, loss of control, or difficulty cutting down.
  • Psychiatric disorders: Mental health conditions that affect mood, thinking, behavior, or daily life.
  • Addictology: A field of medicine that studies and treats addiction and substance-related problems.
  • Interventional study: A study where researchers give a treatment or placebo and measure the results.
  • Phase 4: A late stage of clinical research done after earlier testing, often in real patient groups.
  • Placebo: A treatment that looks like the study drug but does not contain the active medicine.
  • Randomisation: A method that assigns participants by chance to different study groups.
  • Primary outcome: The main result researchers measure to judge whether the study works.
  • Diazepam-equivalent: A way to compare different benzodiazepines by converting them into a common measurement based on diazepam.

References