Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
ConditionBenzodiazepine Dependence
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospices Civils de Lyon
About this trial
Benzodiazepines and related molecules are among the most prescribed psychotropic treatments in France and Europe. 13.4% of the French population had at least one reimbursement of benzodiazepines in 2015, which places France second in Europe.
However, the chronic use of benzodiazepines is a source of numerous complications, particularly addictive. To date, there is no authorized pharmacological treatment for benzodiazepine withdrawal.
Baclofen is a gamma-aminobutyric acid (GABA)-B agonist, a pharmacological receptor that regulates GABA-A, the target of benzodiazepines. The pharmacological mechanisms of baclofen are therefore related to those of benzodiazepines. Empirical use outside of the MA has shown that baclofen can facilitate the reduction of benzodiazepines in cases of severe addiction, but this pharmaceutical interest remains to be demonstrated in a comparative study.
The main objective of the project is to evaluate the efficacy of baclofen, compared to placebo, in reducing benzodiazepine doses in patients with benzodiazepine use disorder (BUD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 18 years to ≤ 65 years
negative pregnancy test at inclusion
and use of effective contraception which will be continued throughout the trial period
and agrees to carry out pregnancy tests throughout the trial period.
Disqualifiers
Cirrhosis of the liver
Patients with significant medical conditions such as cancer, HIV, epilepsy, chronic respiratory failure, renal failure, etc.
Non-compatible health conditions (at the discretion of the investigator)
The following psychiatric conditions as defined by DSM-5 criteria: schizophrenic disorder, persistent delusional disorder, schizophreniform disorder, schizoaffective disorder, bipolar disorder, autism spectrum disorder identified using the Mini International Neuropsychiatric Interview version 7.0.2 (MINI 7.0.2)
Trial design
Design model
Parallel
Treatments tested in this trial
Baclofen 30 mg
Drug* baclofen 10 mg capsule (for the 30 mg-baclofen 30 mg arm) * Dosage: 3 capsules of baclofen 10 mg per day * route of administration: Oral * duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation
Baclofen 60 mg
Drug* baclofen 20 mg capsule (for the 60 mg baclofen arm) * Dosage: 3 capsules of baclofen 20 mg per day * route of administration: Oral * duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation
Placebo
Drug* placebo capsule (for the placebo arm) * Dosage:3 capsules of placebo per day * route of administration: Oral * duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation
Treatment groups
93 Participants
are divided into 3 treatment groupsGroup A: Baclofen 30 microgram (mg) treatmentExperimental treatment 1 intervention
Group B: Baclofen 60 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in total benzodiazepine consumption, in mg-diazepam
This difference will be compared between the two groups (winning baclofen group and placebo group). Total benzodiazepine consumption will be measured using the Benzodiazepine Timeline Follow-Back (B-TLFB). A mean value (in mg/d) for the 28 days of consumption will be calculated for each patient (between the 28 days prior to inclusion in the clinical trial and the last 28 days of the clinical trial).
Time frame
between the 28 days before inclusion in the clinical trial and the last 28 days of the clinical trialSecondary outcomes
1
Frequency of serious adverse events of special interest
The frequency of serious adverse events of particular interest will be collected from inclusion to the end of the study for each patient.
Time frame
through study completion, an average of 4 and a half months2
Frequency of non-serious adverse events of special interest
The frequency of non-serious adverse events of particular interest will be collected from inclusion to the end of the study for each patient.
Time frame
through study completion, an average of 4 and a half months3
frequency of all-cause study discontinuations
frequency of all-cause study discontinuations will be collected from inclusion to the end of the study for each patient.
Time frame
through study completion, an average of 4 and a half months4
Frequency of benzodiazepine discontinuation at the last visit of the treatment period by urine test
Toxicology will be measured by a urine test during the last visit of the treatment period.
Time frame
at study completion, an average of 4 and a half monthsSponsors and contacts
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Source ClinicalTrials.gov