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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005787-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Société de Formation Thérapeutique du Généraliste | OTHER |
| Hôpital Cochin | OTHER |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The main objective of this study is to show the effectiveness to a year of baclofen compared to placebo, on the proportion of patients with a low risk alcohol consumption or no, according to the WHO standards.
Baclofen, a gamma-aminobutyric acid 'B-receptor' agonist, has long been used to treat spasticity from neurological diseases, at a dose of 30-90 mg/day. It appears today to be a promising but controversial candidate for treating alcoholic patients (Enserick, 2011) by reducing or even suppressing their craving to drink. A few case reports (Ameisen, 2005; Bucknam, 2007; Dore et al., 2011) and a retrospective study (Rigal et al, 2012) suggest that some patients might respond favorably to baclofen at higher doses than 90 mg/day. This is a randomized controlled trial versus placebo testing such doses.
An extraction of patients DNA and a genetic analysis will be done after the end of the trial. In a gene candidate approach, the association of several genes with the efficiency of the treatment and its side effects, based on the literature, will be investigated using micro-array technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baclofen | Experimental | Baclofen will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams three times a day; then the dose of baclofen will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased. |
|
| Placebo | Placebo Comparator | Sugar pill will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive sugar pill in a dose of 5 milligrams three times a day; then the dose of sugar pill will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug | Baclofen will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams three times a day; then the dose of baclofen will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of abstainer patients and patients with a low risk consumption | Low risk consumption according to the criteria of WHO (World Health Organization). The assessment will be on the declarative of the patient (with autoquestionnaire). It will be compared between the two groups using a Chi-2 test. | 12 months after the initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Efficience dosage of baclofen | Published studies indicate that the average dose would be about 140 mg per day without, a priori, report with the weight of the patient. Animal studies show an optimal dose of 3 mg/kg. | 12 months after the initiation of treatment |
| To evaluate the tolerance of baclofen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Jaury, MD, PhD | University of Paris 5 - Rene Descartes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paris Descartes University | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31833590 | Result | Rigal L, Sidorkiewicz S, Treluyer JM, Perrodeau E, Le Jeunne C, Porcher R, Jaury P. Titrated baclofen for high-risk alcohol consumption: a randomized placebo-controlled trial in out-patients with 1-year follow-up. Addiction. 2020 Jul;115(7):1265-1276. doi: 10.1111/add.14927. Epub 2020 Feb 16. | |
| 33012365 | Derived |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | Sugar pill will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive sugar pill in a dose of 5 milligrams three times a day; then the dose of sugar pill will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased. |
|
To try, if possible, to differentiate which is due to the molecule, which is due to the stop of drinking alcohol and which is due to the alcohol-baclofen potentiation and looking for all the side effects including at high dosages. |
| 12 months after the initiation of treatment |
| To better characterize the alcoholic patients in whom this molecule is effective | By using the anxiety/depression HAD scale. By using the scale of craving (Obsessive Compulsive Drinking Scale). By using the DSM - IV for the dependency. | 12 months after the initiation of treatment |
| Evolution of patients under treatment | At each consultation, the consumption self-assessment questionnaire is analysed with the patient (book of follow-up) and missing data are sought and completed. To describe the evolution of patients under treatment from the point of view of the total consumption of alcohol, the monthly average consumption, the number of days of abstinence, the number of "heavy drinking days". | 12 months after the initiation of treatment |
| Cumulative quantity of alcohol drunk in the last month | To analyse the cumulative quantity of alcohol drunk by the patient during the last month of treatment | 12 months after the initiation of treatment |
| Quality of life during treatment | To assess the quality of life during treatment by using the scale SF36 at the beginning and at the end of the study. | at Day 1 and 12 months after the initiation of treatment |
| Evolution of biology | To study the evolution of biology, including liver, compared to the declaration made by the patient from his response to treatment. Biological examinations will be performed at the beginning, at 6 month and at the end of the trial. | At day one, 6 months and 12 months after the initiation of treatment |
| 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. |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |