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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003336-23 | EudraCT Number |
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Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference medication for preventing or treating AWS. The recommended average diazepam treatment duration is usually around one week, and this duration is generally not considered to impact the subsequent relapse rate in alcohol drinking.
However, several previous studies have found that patients experienced frequent anxious symptoms during the weeks following detoxification. Such symptoms may foster early relapse in alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late withdrawal symptoms.
The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one month can significantly reduce the cumulated relapse rate in alcohol drinking over the three following months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD = "as-usual diazepam" | Active Comparator | Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification). |
|
| PD = "prolonged diazepam" | Experimental | Diazepam will be slowly tapered to be stopped at day 30 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazepam | Drug | 40 mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of relapse in alcohol drinking | Proportion of patients who will have reported any alcohol drinking over the three months following the beginning of the detoxification procedure (using the alcohol timeline follow-back method). | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | Over the first month, at 3 months | |
| Rate of relapse in heavy drinking | Proportion of patients who will have reported at least one heavy drinking day, i.e., ≥ 50 g of alcohol in a day, over the first month and the three month following the beginning of the detoxification procedure (using the alcohol timeline follow-back method). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin ROLLAND, MD, PhD | University Hospital of Lille (CHU Lille), France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Addiction Medicine | Lille | 59037 | France | |||
| Outpatient Addiction Center "CSAPA - Le Pari" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28984747 | Result | Simioni N, Labreuche J, Behal H, Cottencin O, Rolland B. Thirty- Versus Ten-Day Diazepam Treatment for Alcohol Detoxification and a Comparison of Drinking Patterns, Craving, and Anxiety for up to 12 Weeks: A "Proof-of-Concept" Open-Label Randomized Controlled Trial. J Clin Psychopharmacol. 2017 Dec;37(6):722-728. doi: 10.1097/JCP.0000000000000786. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D012008 | Recurrence |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| at 1 month; at 3 months |
| Ratio of drinking days/heavy drinking days | over the first month, at 3 months |
| Level of self-reported anxiety | Score of self-reported anxiety using the State-Trait Anxiety Inventory | at 1 month; at 3 months |
| Level of clinician-assessed anxiety | Score of anxiety using the Hamilton Anxiety Rating Scale | at 1 month; at 3 months |
| Level of alcohol craving | Level of alcohol craving using the Obsessive-Compulsive Drinking Scale | at 1 month; at 3 months |
| Average weekly alcohol consumption | at 1 month; at 3 months |
| Lille |
| 59037 |
| France |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |