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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2016 |
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Main ID: |
NCT02242955 |
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Date of registration:
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15/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
DIAMA |
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Scientific title:
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Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02242955 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Benjamin ROLLAND, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Lille (CHU Lille), France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- DSM-IV-Tr criteria for alcohol dependence
- Diazepam-based outpatient detoxification procedure started 5 days prior to inclusion
Exclusion Criteria:
- contraindication for outpatient detoxification
- occurrence of delirium tremens or seizures during the pre-inclusion period
- contraindication for using diazepam
- any other DSM-IV-TR criteria for substance abuse or dependence in the preceding year
(except from tobacco)
- concurrent axis-I psychiatric disorder
- concurrent neurological pathology or cognitive impairment
- concurrent social risk, i.e., homelessness or social isolation
- liver failure, cancer, or significant breathing disorder
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alcoholism
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Intervention(s)
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Drug: Diazepam
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Primary Outcome(s)
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Rate of relapse in alcohol drinking
[Time Frame: at 3 months]
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Secondary Outcome(s)
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Average weekly alcohol consumption
[Time Frame: at 1 month; at 3 months]
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Rate of relapse in heavy drinking
[Time Frame: at 1 month; at 3 months]
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Level of clinician-assessed anxiety
[Time Frame: at 1 month; at 3 months]
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Level of self-reported anxiety
[Time Frame: at 1 month; at 3 months]
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Level of alcohol craving
[Time Frame: at 1 month; at 3 months]
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Occurrence of adverse events
[Time Frame: Over the first month, at 3 months]
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Ratio of drinking days/heavy drinking days
[Time Frame: over the first month, at 3 months]
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Secondary ID(s)
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2012-003336-23
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2011_44
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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