Liver Cirrhosis, AlcoholicPhase 1/2NCT00525252
Efficacy of Baclofen in the Treatment of Alcohol Addiction
A Phase 1/2 study testing Baclofen in people with Liver Cirrhosis, Alcoholic, run by Catholic University of the Sacred Heart.
Trial summary
Intervention to achieve alcohol abstinence represents the most effective treatment for alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of anti-craving drugs in these patients because of the concern that these medications might worsen liver disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Alcoholic
- 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
- 86 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Nov 2006
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ranging from 18 to 75 years
- diagnosis of alcohol dependence according to DSM IV criteria
- diagnosis of liver cirrhosis
- alcohol intake of at least 2 heavy drinking days (men > 5 drinks/days; women > 4 drinks/day) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to enrolment
- presence of a referred family member
Who cannot join
- severe heart or lung disease
- kidney alterations and/or hepato-renal syndrome
- tumours, including hepatocellular carcinoma
- metabolic diseases, including diabetes
- clinical signs of hepatic encephalopathy
- patients treated with interferon or corticosteroids within the last 60 days
Show all 9Show fewer
- psychopathological illness undergoing treatment with psychoactive drugs
- epilepsy or epileptiform convulsions
- addiction to drugs other than nicotine
About this study
Official title: Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study
Intervention to achieve alcohol abstinence represents the most effective treatment for alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of anti-craving drugs in these patients because of the concern that these medications might worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have been reported in treated patients. The present study investigates the efficacy and safety of baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients.
- Conditions
- Liver Cirrhosis, Alcoholic
- Being tested
- Baclofen, placebo
- Keywords
- Liver cirrhosis, Alcoholism, Craving
- Medical subject headings
- Liver Cirrhosis, Alcoholic, Liver Cirrhosis, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Baclofen orally administered for 12 consecutive weeks. For the first 3 days, baclofen administered at a dose of 5 milligrams 3 times per day; subsequently, the daily dose of baclofen will be increased to 10 milligrams 3 times per day.
placeboDrug
Placebo will be orally administered for 12 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | A total of 42 alcoholic patients with liver cirrhosis treated with placebo Receives: Drug: placebo |
| 1 | Active comparator | a total of 42 alcoholic patients with liver cirrhosis treated by baclofen Receives: Drug: Baclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total alcohol abstinence; cumulative abstinence duration
Measured: 12 weeks
Secondary outcomes (1)
Obsessive and Compulsive craving
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startFeb 2003
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Cirrhosis, AlcoholicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Addolorato, M.D., Principal investigator, Catholic University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525252
- Sponsor's protocol ID
- Bacl001
- Status last verified
- Sep 2007
- First submitted
- 4 Sep 2007
- Last updated
- 5 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Addolorato G, Caputo F, Capristo E, Domenicali M, Bernardi M, Janiri L, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002 Sep-Oct;37(5):504-8. doi: 10.1093/alcalc/37.5.504.
PubMed 12217947Addolorato G, Leggio L, Ferrulli A, Cardone S, Vonghia L, Mirijello A, Abenavoli L, D'Angelo C, Caputo F, Zambon A, Haber PS, Gasbarrini G. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. Lancet. 2007 Dec 8;370(9603):1915-22. doi: 10.1016/S0140-6736(07)61814-5.
PubMed 18068515
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study
- ClinicalTrials.gov ID
- NCT00525252
- Acronym / sponsor ID
- Bacl001
- Conditions
- Liver Cirrhosis, Alcoholic
- Keywords
- Liver cirrhosis, Alcoholism, Craving
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Nov 2006 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intervention to achieve alcohol abstinence represents the most effective treatment for alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of anti-craving drugs in these patients because of the concern that these medications might worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have been reported in treated patients. The present study investigates the efficacy and safety of baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: placeboA total of 42 alcoholic patients with liver cirrhosis treated with placebo |
| 1 | Active comparator | Drug: Baclofena total of 42 alcoholic patients with liver cirrhosis treated by baclofen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ranging from 18 to 75 years
- diagnosis of alcohol dependence according to DSM IV criteria
- diagnosis of liver cirrhosis
- alcohol intake of at least 2 heavy drinking days (men > 5 drinks/days; women > 4 drinks/day) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to enrolment
- presence of a referred family member
Key exclusion criteria (9 listed)
- severe heart or lung disease
- kidney alterations and/or hepato-renal syndrome
- tumours, including hepatocellular carcinoma
- metabolic diseases, including diabetes
- clinical signs of hepatic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaclofenBaclofen orally administered for 12 consecutive weeks. For the first 3 days, baclofen administered at a dose of 5 milligrams 3 times per day; subsequently, the daily dose of baclofen will be increased to 10 milligrams 3 times per day. | Drug | 1 |
| placeboPlacebo will be orally administered for 12 consecutive weeks | Drug | 2 |
Primary outcome
Total alcohol abstinence; cumulative abstinence duration
Time frame: 12 weeks
1 secondary outcome
Obsessive and Compulsive craving
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2007.
- Background: PubMed 12217947Addolorato G, Caputo F, Capristo E, Domenicali M, Bernardi M, Janiri L, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002 Sep-Oct;37(5):504-8. doi: 10.1093/alcalc/37.5.504.
- Derived from this study: PubMed 18068515Addolorato G, Leggio L, Ferrulli A, Cardone S, Vonghia L, Mirijello A, Abenavoli L, D'Angelo C, Caputo F, Zambon A, Haber PS, Gasbarrini G. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. Lancet. 2007 Dec 8;370(9603):1915-22. doi: 10.1016/S0140-6736(07)61814-5.
Related trials for Liver Cirrhosis, Alcoholic
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
RecruitingPhase 3
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
RecruitingPhase 3
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Metabolic Dysfunction Associated Steatohepatitis
Not yet recruitingObservational study
Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
Cirrhosis Alcoholic, Fatigue Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Addolorato, M.D. principal investigator
Catholic University of Rome
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Baclofen in people with Liver Cirrhosis, Alcoholic, run by Catholic University of the Sacred Heart.
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 5 inclusion and 9 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 5 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total alcohol abstinence; cumulative abstinence duration (time frame: 12 weeks). 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 NCT00525252, which also lists 2 linked publications.
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 5 Sep 2007.