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Alcohol DependencePhase 3ALPADIRNCT01738282

Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients

A Phase 3 study testing Baclofen in people with Alcohol Dependence, run by Ethypharm at 38 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Dependence
What is being tested?
Baclofen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
316 participants
Where
38 sitesFrance
Study dates
Dec 2012to Jul 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients meeting DSM IV(Diagnosis and Statistical Manual of Mental Disorders, 4th edition) criteria for alcohol dependence
  • Willing to participate in the study and express a desire to achieve the objective of continuous and long term abstinence after withdrawal
  • Abstinent (last drinking) for a minimum of 3 days and maximum of 14 days
  • At least one previous abstinence attempt

Who cannot join

  • Need for a stay at the end of the withdrawal period in a health care and rehabilitation institution specialized in addiction
  • Need for a heavy psychosocial out of hospital care
  • History of baclofen intake, by prescription or self medication
  • Porphyria
  • Concomitant treatment with one or several drugs for the maintenance of abstinence
  • Severe renal, cardiac or pulmonary disorder
Show all 13Show fewer
  • Epilepsy or history of epilepsy
  • Concomitant treatment with psychotropic drugs, except antidepressants at stable dose for 2 months, diazepam and oxazepam
  • Severe psychiatric disease (schizophrenia and bipolar disorder)
  • Suicidal risk or history of suicide
  • Clinically significant cognitive disorders
  • Hepatic encephalopathy
  • Ongoing dependence or within the last 12 months on other addictive substances (opioid, cocaine, cannabis, other substances or drugs…), excepted tobacco

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

France38 sites

  • Study site

    Angers

  • Study site

    Bron

  • Study site

    Clermont de l'Oise

  • CHU

    Clermont-Ferrand

  • Hopital Beaujon

    Clichy

  • Study site

    Dax

  • Centre hospitalier

    Dijon

  • Centre hospitalier

    Erstein

  • Centre hospitalier

    La Membrolle-sur-Choisille

  • Hopital Michallon

    La Tronche

  • Study site

    LArbresle

  • Centre hospitalier

    Le Mans

  • CHRU

    Lille

  • CSAPA

    Lille

  • Study site

    Limoges

  • Hopital de la Croix Rousse

    Lyon

  • Hopital Sainte Marguerite

    Marseille

  • Centre hospitalier

    Montauban

  • Study site

    Morlaix

  • Hopital Villemin

    Nancy

  • CHU

    Nantes

  • Centre hospitalier

    Nice

  • CHRU

    Nîmes

  • Hopital Bichat Claude Bernard

    Paris

  • Hopital Cochin

    Paris

  • Hopital Fernand Widal

    Paris

  • Hopital Saint Anne

    Paris

  • Centre hospitalier

    Perpignan

  • Centre hospitalier

    Pont-du-Casse

  • Study site

    Reims

  • Hopital Pontchaillou

    Rennes

  • Hopital de la Fraternité

    Roubaix

  • Study site

    Saint-Égrève

  • Hopital René Muret

    Sevran

  • CSAPA

    Seynod

  • Centre hospitalier intercommunal

    Toulon

  • Hopital Brabois

    Vandœuvre-lès-Nancy

  • Hopital Paul Brousse

    Villejuif

Other trials in France

About this study

Official title: A Randomized, Multicentric, Double Blind Study to Assess the Efficacy of Xylka® (Baclofen) at the Target Dosage of 180mg/Day Compared to Placebo, for Maintenance of Abstinence in Alcohol Dependent Patients

The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions.

Being tested
Baclofen, Placebo (for baclofen)
Keywords
baclofene, Alcohol dependence, Maintenance of abstinence
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaclofenDrug

  • Placebo (for baclofen)Drug

Study groups in NCT01738282
Study groupRoleWhat they receive
BaclofenExperimentalBaclofen 20mg tablet. Titration:increasing dosage regimen to reach the target dosage of 180 mg (9 tablets)in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks
Receives: Drug: Baclofen
PlaceboPlacebo comparatorPlacebo tablet Titration:increasing dosage regimen to reach the target dosage of 9 tablets in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks
Receives: Drug: Placebo (for baclofen)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168.

    Measured: Day 168

Secondary outcomes (7)

  1. Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of the maintenance dose period (Day 168), i.e. 24 weeks

    Measured: Day 168

  2. Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of 4-week post treatment follow up period (Day 210), i.e. 30 weeks

    Measured: Day 210

  3. Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence

    Measured: Day 168

  4. Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the level of drinking before withdrawal (Time Line Follow Back calendar/ World Health Organization criteria for risk of consumption)

    Measured: Day 168

  5. Drinking characteristics for patients having a relapse between Day 1 and Day 210

    Time to relapse (Day 1 to first drinking day) Time to relapse to first high risk drinking day (>60g for a male, > 40g for a female) Percentage of drinking days from Day 1 to Day 210 Mean number of standard drinks per drinking day and classification according to World Health Organization criteria for the risk of consumption Percentage of high risk drinking days during the maintenance period at the target dosage (Day 50 to Day 168) compared to the percentage of high risk drinking days during the preceding 4 weeks of the withdrawal Percentage of drinking days during the maintenance period at the target dosage (Day 50 to Day 168) compared to the percentage of drinking days during the preceding 4 weeks of the withdrawal

    Measured: Day 210

  6. Change in craving, addiction and Quality of Life scales

    Clinical Global Impression (CGI), Alcohol dependence Quality of Life (AlQoL9), Obsessive Compulsive Drinking Scale (OCDS), Hospital Anxiety and Depression Scale (HAD), Visual Analogue Scale (VAS) craving scores and liver biomarkers

    Measured: Day 210

  7. Recording of safety data

    Adverse events, vital signs, biological parameters, ECG and urinary pregnancy test

    Measured: Day 210

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01738282
Sponsor's protocol ID
ALP 2011007/002
Acronym
ALPADIR
Status last verified
Jul 2014
First submitted
26 Nov 2012
Last updated
30 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Braillon A, Naudet F. Pharmacotherapies for Alcohol Use Disorder: Over Both Sides of the Atlantic Ocean. Mayo Clin Proc. 2020 Oct;95(10):2294-2295. doi: 10.1016/j.mayocp.2020.08.005. No abstract available.

    PubMed 33012365

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baclofen in people with Alcohol Dependence, run by Ethypharm at 38 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168. (time frame: Day 168). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01738282, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.

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