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Acute Effects of Cortisol on Alcohol Craving in Alcohol Dependence (CAR-Bern 2013)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02196142
Recruitment Status : Completed
First Posted : July 21, 2014
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol addicted subjects.

Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication.

Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity in alcohol dependent subjects.


Condition or disease Intervention/treatment Phase
Alcohol Craving Psychological Stress Physiological Stress Drug: Cortisol 20mg Drug: Placebo Mannitol Phase 3

Detailed Description:

Background

Alcohol dependence is a chronically and relapsing disorder with major impact on the persons psychological, physiological and social functioning. There is extensive evidence from animal and human studies pointing out the important role of addiction memory in the development and maintenance of the disorder.

Cognitive behavioural therapy (CBT) has proven its high effectiveness in the treatment for addictive disorders. A core element of CBT are exposure techniques that are comparable to extinction and habituation learning. The repeated exposure to alcohol related cues in the absence of alcohol ingestion will lead to extinction of conditioned responses, thus reducing the probability of relapse to alcohol taking behaviour.

Studies have shown that glucocorticoids impair memory retrieval in healthy subjects. In fact, the investigators could show that cortisol has a fear reducing effect in patients with post-traumatic stress disorder and in phobic patients, resulting particularly in reduced symptoms of anxiety and in reduced stress reactivity. Interestingly enough, pharmacologically induced high levels of glucocorticoids lowered the subjective feeling of anxiety and stress in situations activating per se the HPA-axis. Further it has been shown that the combined therapy of glucocorticoid administration and exposition based psychotherapy leads to better therapy outcome in patients with specific phobias.

Objective

The goal of this study is to examine the acute effects of glucocorticoids administration on alcohol craving and stress reactivity of abstinent alcohol dependent patients. On the basis of clinical research in anxiety disorders, the investigators expect that a pharmacologically increased cortisol level may impair the retrieval of addiction memory, which is indicated by less craving during the alcohol exposition, while exposition therapy enhances consolidation of corrective experiences. Similar to the research in anxiety patients, the investigators aim to examine whether cortisol administration could help improve the effects of exposition therapy in patients with alcohol dependence. The purpose is to decrease therapy duration through cortisol administration in addition to already well proven therapies and make the therapy more efficient as well as a factor in reducing healthcare costs.

Methods

Patients undergo two identical experimental sessions between the 6th and 8th week (one week in between) of their 12-week inpatient treatment program for alcohol dependence. The experiment takes place in the experimental rooms of the clinic Südhang between 1 and 6 pm. One hour before the confrontation with alcohol associated stimuli patients receive either 20mg of hydrocortisone or placebo (oral administration). The experiment consists of a computer based picture task (alcoholic and neutral pictures) and an in-vivo exposure task. Psychological (craving, stress, arousal) and physiological (heart rate, saliva cortisol) parameters are repeatedly measured over the course of the experiment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Acute Effects of Cortisol on Alcohol Craving in Alcohol Dependence
Study Start Date : November 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Arm Intervention/treatment
Active Comparator: Cortisol first, Placebo second
Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)
Drug: Cortisol 20mg
Drug: Cortisol 20mg

Drug: Placebo Mannitol
Drug: Placebo Mannitol

Active Comparator: Placebo first, Cortisol second
Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)
Drug: Cortisol 20mg
Drug: Cortisol 20mg

Drug: Placebo Mannitol
Drug: Placebo Mannitol




Primary Outcome Measures :
  1. Change from baseline in alcohol craving score [ Time Frame: During and after presentation of drug stimuli, expected to be after 10 minutes ]
    Measured by Alcohol Urge Questionnaire & Visual Analogue Scale


Secondary Outcome Measures :
  1. Change from baseline in State-Trait-Anger Expression Inventory STAXI [ Time Frame: After presentation of drug stimuli, expected to be after 20 minutes ]
  2. Change from baseline in heart rate variability [ Time Frame: During and after presentation of drug stimuli, expected to be after 10 minutes ]
  3. Saliva Cortisol Level [ Time Frame: After presentation of drug stimuli, expected to be after 90 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Abstinent alcoholics in the 12-week in-patient program of the Clinic Südhang
  • Abstained from alcohol for at least 6 weeks
  • Voluntarily signed informed consent

Exclusion Criteria

  • Co-morbid psychiatric disturbances (such as major depression, bipolar disorder, schizophrenia)
  • Current medical conditions excluding participation (such as acute infectious disease)
  • Recent history of systemic or topic glucocorticoid therapy
  • Known hypersensitivity to the IMP under investigation (cortisol)
  • Pregnancy, breast-feeding
  • Inability to read and understand the participant's information
  • Positive alcohol test according to breathalyser

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196142


Locations
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Switzerland
Klinik Südhang
Kirchlindach, Bern, Switzerland, CH-3038
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Director: Leila Soravia, Dr. phil. University Hospital of Psychiatry Bern
Principal Investigator: Peter Allemann, Dr. med. Clinic Südhang
Study Chair: Dominique de Quervain, Prof. Dr. University Hospital, Basel, Switzerland

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02196142    
Other Study ID Numbers: 068/14
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015
Keywords provided by University Hospital Inselspital, Berne:
Cortisol
Alcohol Craving
Alcohol Dependence
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Alcoholism
Stress, Psychological
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Behavioral Symptoms
Ethanol
Mannitol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Anti-Inflammatory Agents