Effects of oral cortisol or propranolol administration on the processing of alcohol-related key stimuli, sleep and relapse risk in alcohol-dependent patients (Copro study)

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Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2010
INTERVENTION: Trade Name: Hydrocortison 10 mg Jenapharm Product Name: Hydrocortison 10 mg Jenapharm Pharmaceutical Form: Over encapsulated tablet Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Dociton 40 mg Product Name: Propranolol Pharmaceutical Form: Over encapsulated tablet Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: alkohol dependence PRIMARY OUTCOME: Main Objective: Improvement of the success of cue‐exposure by administration of hydrocortisone or propranolol, i.e. stronger attenuation of craving for alcohol Primary end point(s): ending cue‐exposure after 10 sessions maximum, last assesment of sleep and memory in the sleep laboratory after end of cue‐exposure treatment. Secondary Objective: 1. improvement of abstination rates; 2. testing and improving emotianal memory function; 3. improvement of sleep profile; 4. normalisation of disturbed cortisol reactivity to stress; 5. testing and improving glucose tolerance and insulin resistance INCLUSION CRITERIA: alcohol dependence, abstention for 3 das minimum before entering the study, male subject, age in the rage 18 to 55 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no
Epistemonikos ID: 5ea6a56ec52a91f40d3182a5bfca3dc29ef4bd74
First added on: Aug 22, 2024
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