Status:

COMPLETED

Acute Effects of Cortisol on Alcohol Craving in Alcohol Dependence

Lead Sponsor:

Insel Gruppe AG, University Hospital Bern

Conditions:

Alcohol Craving

Psychological Stress

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2015

    Estimated Enrollment :

    48 Patients enrolled

    Trial Details

    Trial ID

    NCT02196142

    Start Date

    November 1 2014

    End Date

    June 1 2015

    Last Update

    June 24 2015

    Active Locations (1)

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    Klinik Südhang

    Kirchlindach, Canton of Bern, Switzerland, CH-3038